Tag Archives: Fluoroquinolone toxicity

Dr. Bennett identifies what the government should be doing — but isn’t — to guard against unsafe prescription drugs

Dr. Charles Bennett has been an advocate for addressing fluoroquinolone safety concerns for many years. He has has filed multiple petitions with the FDA to get them to change the warning labels for fluoroquinolones–one of the petitions is to get the FDA to add Psychiatric Adverse Events to the Levaquin/levofloxacin warning label, another is to have the FDA add “Possible Mitochondrial Toxicity” to the Levaquin Label, another requesting a black box warning to specifically identify psychiatric adverse events, including suicide and suicide-related adverse events, and likely others. These petitions have led to warning label changes, and have been featured in many of the news stories about fluoroquinolones. Dr. Bennett has also testified before the FDA about fluoroquinolone adverse reactions, and has helped many “floxies” to gain information and support. He is a wonderful advocate, and his advocacy work has increased the credibility of other advocates for fluoroquinolone toxicity awareness. He has changed how many people think of fluoroquinolones, and he has changed how fluoroquinolones are prescribed. He is making a difference.

Dr. Bennett recently wrote a wonderful editorial that was published in the LA Times entitled, “What the government should be doing — but isn’t — to guard against unsafe prescription drugs.” I highly recommend that you read and share it. He has some great ideas and insights, some of which I’m going to highlight in this post (all italicized and indented sections of this post are quotes from the editorial).

He, and his co-authors, state:

The failings are at every point in the system, starting with drug approvals. But we believe there is a particularly serious problem with the mechanisms for identifying, monitoring and disseminating information about issues with a drug after its release.

Once a drug is approved for market, the FDA relies on an informal and ineffective system of case reports and citizens’ petitions to alert it to problems and adverse events. In the past, case reports, submitted to medical journals by physicians, served as an important mechanism for detailing drug toxicity. But today, because of changes to editorial guidelines, peer-reviewed journals rarely accept such reports for publication.

Indeed. Take it from a doctor who specializes in studying adverse drug reactions that the current system of tracking and addressing concerns about adverse drug reactions is failing and ineffective. How many of the thousands (perhaps millions) of adverse reactions to fluoroquinolones have been reported to the FDA through either the adverse event reporting system, a case report, or a citizen’s petition? Unfortunately, not many. It should be noted that, “Many studies have documented that only 10%-15% of serious adverse reactions are reported” to the FDA. Though I encourage every “floxie” to report his or her adverse reaction to the FDA, a voluntary reporting system that is confusing and difficult to navigate, is not a particularly effective way of tracking the actual incidence of adverse drug reactions.

Dr. Bennett also notes that Citizen’s Petitions (many of which he has filed) are not an effective tool for tracking and evaluating post-market adverse drug reactions:

Citizens’ petitions, in which any citizen can petition the FDA to report adverse drug effects, are intended to be another check. But the petition process is cumbersome, and they are rarely granted. Of the 1,915 Citizens Petitions filed in the 12-year period between 2001 and 2013, a total of 13 were granted. Many go unanswered altogether.

The citizen’s petitions filed by Dr. Bennett, Public Citizen, and others, have been helpful advocacy tools, but, as Dr. Bennett and his co-authors point out, they have not been adequate.

Rather than continuing with the ineffective system of depending on patient and doctor reports of adverse reactions, citizen’s petitions, and case-reports to monitor and track adverse drug reactions, Dr. Bennett suggests that a new system for tracking and monitoring drugs with black-box warnings be implemented.

We propose a “black box” database or “registry,” publicly available and simple to use, that would contain extensive information about where, by whom and for what purpose black box drugs are prescribed, as well as where and in what quantities such drugs are being distributed and sold. Information about adverse side effects, culled from the myriad of government databases that now collect them, would also be consolidated in an open form and format.

In addition to the benefits of a black box database/registry noted above, a black box database/registry also has the potential to decrease usage of drugs that have black box warnings:

Is there a chance that the existence of a black box registry would decrease the use of those drugs? Possibly, and that would be a good thing. Too often black box warnings are seen as meaningless, and they are counteracted with marketing campaigns that promote off-label use. If adding more transparency, thought and effort to the prescription and sale of dangerous drugs winds up decreasing their use, that will likely be a beneficial side effect.

It would be WONDERFUL if there were a system in-place that cut down on unnecessary fluoroquinolone prescriptions. It would be WONDERFUL if there were a system in-place that adequately communicated the real risks of fluoroquinolones. I think that Dr. Bennett’s idea of creating a black box registry is an excellent way to do both those things, and it’s absolutely worth a try. The system that we currently have for tracking and addressing adverse drug reactions is woefully inadequate. Change is good – especially if it is in the direction of making people safer.

Thank you Dr. Bennett and co-authors for writing “What the government should be doing — but isn’t — to guard against unsafe prescription drugs.” Your insights and advocacy are greatly appreciated!

*****

Prominent Activist Notes Possible Connections Between Fluoroquinolones and ME/CFS

I’m a big fan of Jennifer Brea–an activist and advocate for those with ME (Myalgic Encephalomyelitis – also known as Chronic Fatigue Syndrome or CFS), and the filmmaker behind the wonderful documentary Unrest. She is also heavily involved with the ME Action Network, “A global, grassroots network for people with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome,” and a blogger on Medium. She is powerful, thoughtful, interesting, insightful, an amazing leader, and she has helped thousands (maybe millions) of people with ME to live with, and maintain hope through, a horrible and debilitating disease. She has brought understanding of the horror of ME to people in a way that is empathetic and thought provoking. She is a wonderful advocate for her community.

AND, I’m excited to tell the “floxed” community…

Fluoroquinolones are on her radar as a possible cause of connective tissue disorders that may lead to ME.

In her July 10, 2019 post, “Onset: Part III (Connections),” she notes that antibiotics are a potential cause of collagen and connective tissue disorders:

Antibiotics: doxycycline, which anecdotally some patients have benefited from, inhibits MMPs. Fluroquinolone antiobiotics, which can produce an ME/CFS-like illness, increases MMPs and in December 2018, the FDA issued a warning against its use in patients with Ehlers-Danlos Syndrome and Marfan Syndrome.”

Indeed, fluoroquinolones increase production of MMPs–a category of enzymes that are capable of degrading all kinds of extracellular matrix proteins including, but not limited to, the structural proteins of the aortic wall.

The article, “Ciprofloxacin enhances the stimulation of matrix metalloproteinase 3 expression by interleukin‐1β in human tendon‐derived cells” notes the following:

In this study, we have shown that the antibiotic ciprofloxacin, which induces tendon pain in some patients (1) and tendon pathology in rodents (3, 4), can increase MMP expression in human tendon‐derived fibroblasts. Specifically, ciprofloxacin potentiated IL‐1β–stimulated expression of MMP‐3 at both the mRNA and protein level.

Tendon pain and degeneration have been associated with an increase in the normal turnover of matrix proteins (9, 10, 12). MMP‐3 has a broad substrate specificity; it is able to degrade matrix components including type III collagen and the proteoglycans aggrecan and versican, and is capable of activating a variety of other MMPs and pro–tumor necrosis factor (11). However, its role in tendon physiology and pathology has not been clearly defined.

Our results raise the possibility that a combination of fluoroquinolone and (fluoroquinolone‐induced) inflammatory mediators might result in the inappropriate or unbalanced expression of MMPs.

Changes in expression of matrix components such as collagen and proteoglycans have also been reported in response to various fluoroquinolones.

The increase in MMP expression may not be the only way that fluoroquinolones damage and destroy connective tissues, but it’s almost certainly one way.

More information about the increase of MMP expression caused by fluoroquinolone antibiotics can be found in the post, “Fluoroquinolones Increase Expression of MMPs” as well as these links:

In a couple posts on this site, I have noted that ME/CFS caused by connective tissue disorders may be proceeded (even caused by) fluoroquinolone exposure. You can read about these theories in the posts Are Fluoroquinolones Causing Connective Tissue Disorders that are Leading to ME/CFS? and Do Fluoroquinolones Cause Cerebrospinal Fluid Leaks?

In Jen Brea’s post she note that there are many causes of collagen and connective tissue disorders, including viral infections, bacterial infections, mold, pregnancy, surgery, car accident, concussion, Ehlers-Danlos Syndrome and other connective tissue disorders, and sex hormones.

It is likely that many people who suffer from ME/CFS, as well as many “floxies,” have been exposed to several of these triggers. Personally, I was exposed to both fluoroquinolone antibiotics and changes in sex hormones (my period) when the flox bomb went off in me. I don’t think I had an actual infection, but most people also have a concurrent bacterial or viral infection when they take fluoroquinolones. I have also surmised in the past that perhaps floxies (as well as people with ME/CFS) have a yet-to-be-discovered form of Ehlers-Danlos syndrome. I also think that there are genetic predispositions to both fluoroquinolone toxicity and ME/CFS, and that the RCCX theory by Dr. Sharon Meglathery is a good place to start when looking at genetic predispositions for all sorts of mysterious illnesses. On the site https://www.rccxandillness.com/ Dr. Meglathery states:

“I believe that the RCCX Theory solves some of medicine and psychiatry’s greatest mysteries. The RCCX Theory explains the co-inheritance of a wide range of overlapping chronic medical conditions in individuals and families (EDS/hypermobility, autoimmune diseases, chronic fatiguing illness, psychiatric conditions, autism, etc.). It explains the underlying pathophysiology of chronic fatiguing illnesses with so many overlapping features (EDS-HT, CFS, Chronic Lyme Disease, Fibromyalgia, toxic mold, Epstein Barr Infection, MCAS, POTS, etc.). And finally, it reveals the gene which I believe confers a predisposition toward brilliance, gender fluidity, autistic features, and stress vulnerability, as well as the entire spectrum of psychiatric conditions (other than schizophrenia which can be co-inherited).”

Though there is significant overlap between fluoroquinolone toxicity and ME/CFS they are not the same, and there are many people suffering from ME/CFS who had other triggers set off their illness. With that said, the evidence that ME/CFS is a connective tissue disorder is mounting, and if a debilitating disease like ME/CFS is caused by disordered connective tissues, perhaps drugs that are known to cause connective tissue disorders (fluoroquinolones) shouldn’t be prescribed by the millions each year.

I appreciate that a leader like Jennifer Brea has the fluoroquinolone connection on her radar, and I hope that those in the ME/CFS community that are floxies as well are able to gain insight and support from both our communities.

I also suggest that everyone watch her wonderful film, Unrest. As a recent floxie hope commenter said, “It’s a good window of what it’s like to live with a chronic illness and I think a great example of what it’s like to have a supportive partner (her husband Omar).” Here’s the trailer:

At the risk of sounding too much like a fan-girl, I’m pretty stoked that fluoroquinolone toxicity is on Jen Brea’s radar, because I think she’s amazing. Read and watch her work, and I think you’ll agree. Much of it will likely resonate with many “floxies” as well.

*****

 

Floxed Friday – Levofloxacin in the Hospital

Every Friday Michelle Polacinski, a Floxie as well as the Director and Producer of ‘Floxed,’ sends out a newsletter to those who have subscribed to the ‘Floxed’ newsletter. The Floxed Friday updates are always interesting and thoughtful, and Michelle has given me permission to share them here. 
 
If you would like to receive the Floxed Friday updates directly from Michelle, please subscribe to the Floxed Documentary email list. You can subscribe through THIS LINK. Subscribing also helps Michelle to gain funding for the Floxed Documentary, and she doesn’t send out spam. 
 
The following was written by Michelle: 

I almost missed the Floxed Friday update this week because for the past few days, we have been applying to grants to finish post-production (and scheduling the rest of production – very exciting!) and I’ve been tending to my grandmother with her recent dementia episode.

Because of this, I’ve been in-and-out of the hospital, working from my phone. After getting floxed myself, I had PTSD, triggered any time I entered a hospital or even thought about a hospital. If you haven’t read my floxie story, it’s here, but TL;DR: (“too long, didn’t read” for those of you unfamiliar with internet culture), I had a horrendous experience admitted to one of the worst hospitals in Los Angeles while neurotoxic. Thanks to a ton of work with an amazing PTSD therapist, I am no longer triggered by hospitals. Still, it isn’t fun for anyone to spend three days in-and-out of one.

While waiting for a prescription antibiotic the other day (yes, I checked – it wasn’t a fluoroquinolone), I overheard someone at the window say “levofloxacin” to another patient. Although I’m not afraid of hospitals, anything with “-floxacin” makes my heart beat a little faster. I immediately questioned what to do.

Should I say something? We are in a hospital, it could be prescribed appropriately, but outpatient? Would saying something change anything or just make things worse? Would they believe me? Is it too late anyway? I didn’t even see who it was.

Sitting with my uncle, who had previously told me that a coworker of his takes Cipro regularly “with no side effects” and yes, he did tell him what happened to me, I figured that saying anything (which would violate HIPAA anyway) may not matter at all, so I sat in silence, impatiently tapping the chair. I’m already doing something. We’re making a film about this. It’s okay. They are explaining the side effects. Relax.

It’s frustrating to feel helpless in scenarios like these, especially considering you don’t want to be seen as the “crazy person” yelling at a complete stranger, telling them about that one drug that ruined your life with words like “mitochondria damage, tendonitis, and neurotoxicity,” even if that’s the first instinct. Yelling, making scenes, and applying a sense of urgency to your tone rarely makes anyone listen. Dare I say, it may hurt the cause.

Thankfully, during an interview with Dr. Joe Ketcherside, MD last week, we discussed possible solutions to end antibiotic misuse once-and-for-all. I want to tell you guys everything we discussed because as a former neurosurgeon, Joe has a lot of experience with antibiotics and a passion for change. He had a lot to say and even gave me a bit of hope. However, you will have to wait until the film is out!

Until then, we will be searching for funding so we can finish this thing and I will still visit hospitals regularly… unfortunately. If you would like to help in any way, feel free to email us.

Have a great weekend!

Best,

Michelle Polacinski
Floxie, Director, and Executive Producer of ‘Floxed’

******

 

Finding the Silver Linings

“Do some good things possibly come out of it? That’s not the point! Some good things come out of a car wreck, but that doesn’t mean we need to have car wrecks. That’s a dumb-butt idea. You can find good out of almost anything. You get enough manure you can grow things with it. There’s good in almost everything. But that doesn’t mean it doesn’t stink to high heaven.” -Dave Ramsey (speaking about things that have absolutely nothing to do with fluoroquinolone toxicity, I just liked the little rant.)

This post is about the lipstick on the pig that is fluoroquinolone toxicity. There are several shades of lipstick that I’m going to point out in this post, and some of the shades are lovely, but they’re still on the big, fat, stinking, disgusting pig of fluoroquinolone toxicity.

No matter what good has come to my life, or the life of anyone else, from fluoroquinolone toxicity, it was still an awful and painful thing to experience. Sometimes pain and suffering lead to growth, and sometimes that growth is valuable or even beautiful, but that doesn’t make the pain or suffering “worth it” or justified in any way. You don’t torture people to make them stronger. You don’t poison people so that they can shift their perspective on the world. You don’t damage every tendon in a person’s body so that they can feel better about saving their children from their fate.

I know that fluoroquinolone toxicity is awful, and that most people would say that ZERO good has come from it for them. Fluoroquinolones have ruined people’s lives. They have killed people. They have disabled people, stolen careers, destroyed relationships, and smashed dreams.

This post is not to justify the pain that fluoroquinolones brought to me or anyone else. The harm that these drugs have done isn’t justifiable.

But life is complicated, and figuring out how to wrap your head around something like fluoroquinolone toxicity isn’t black/white. Perhaps finding the good in difficult situations is helpful (or even necessary) to move on from fluoroquinolone toxicity. Maybe it’s even healing.

A lot of good has come to my life since getting “floxed,” and some of those good things are a direct result of getting floxed. In no particular order, here are some of my silver linings of fluorouqinolone toxicity:

  1. I have this web site. Floxiehope has been a blessing for me in more ways than I can count. It has given me community, purpose, passion, drive, a powerful tool through which to communicate with others, and so much more. I am grateful for all the good that this site has brought to my life.
  2. I now have empathy for people who are suffering from multi-symptom chronic illness. I was never callous toward people with poorly understood illnesses, but I never made any effort to understand them before I got floxed. I now have appreciation for how difficult ME/CFS, Lyme disease, multiple chemical sensitivities, POTS, autoimmune diseases, iatrogenic illnesses of all types, etc. are for people. I now understand that these diseases are incredibly complex and poorly understood, and that people who suffer from them are often victimized over and over again by both the medical system and society at-large.
  3. I have a community of floxed people throughout the world that I love. I have connected with people all over the world who have suffered from the adverse effects of these drugs. These connections have added to my life in wonderful ways.
  4. I now see the harm that pharmaceuticals can do, and I will never blindly trust the pharmaceutical industry, or doctors, again. I think that this skepticism will protect me.
  5. I learned patience and kindness toward myself. I was really hard on myself while I was sick. It didn’t help. Eventually learning patience and kindness for my body, soul, and all other aspects of my self was helpful, and it made me a better person.

Fluoroquinolone toxicity has been such a big part of my life for so long that it has touched every aspect of my life, and all the good and bad that has happened since 2011 has something to do with my journey through fluoroquinolone toxicity. It shaped me. It shaped me into the woman who my husband fell in-love with and married. It shaped me into the woman who took the job that I now have. It shaped me into the friend I am today, and even the daughter I am today. I cannot separate any aspect of my life from the effects of fluoroquinolones because they changed the course of my life.

This post was inspired by a post in The Fluoroquinolone Toxicity Group on Facebook. In it, Gene asked, “Often we hear of people going through a trial in life and then they say, “X was the best thing that ever happened to me”. Can anyone share a ‘best thing’ story about their fluoroquinolone story?”

Several people responded with really thoughtful and insightful answers. With their permission, I am sharing some of the things they wrote:

Alanna: “I was always a health nut, but I became much more informed & disciplined about my general health & healing protocols that work with the body, not against it. I like to help people, including passing on what I’ve learned. My faith deepened, I had miracle answers to prayer. My husband stepped up & did hero’s work, bringing us closer. With limited energy, I trimmed the extraneous out of my life to focus on that which has value, It straightens out your priorities, doesn’t it.”

Charles: “I changed my whole perspective on life, brought me back into my faith, and generally has helped me become a much better person emotionally and spiritually”

Amanda: “Got the opportunity to dive deep with my spirituality. I’ve learned what is and what is not worth my time and energy. I’m much more compassionate and am learning how to be more assertive, as I have to voice my needs for quality of life.”

Annette: “I learned how to be my own doctor. I learned not to trust or rely on anyone but myself (that may sound like a negative, but it has actually served me well post FQ).”

Nora: “Confirmed my belief that Western medicine is about masking symptoms and a business and that sauna, fasting, exercising, and eating well make a difference in one’s health.”

Gene: “I think the best thing I can say about it is I’ve learned that I seem to have an endless will to fight and to not accept that small chalky things i put in my mouth will win. When the first symptoms hit in 2010 I said ” I do not accept this”. I’ve been fighting ever since to figure out ways to get my health back. So I am incredibly strong in that way, even if my body doesn’t always feel strong. The other thing I have gained in this is a stronger faith in the fact that there is much more to this than 80 years and than the end. We enter another world and this one will be but the blink of an eye. So maybe it is teaching me patience as well. The hardest lesson i am beginning to learn and I try to do is forgive the doctor. He did not intentionally hurt me. He is also the victim in a dysfunctional medical system. There are some powerful people in the fluoroquinolone distribution system who I do believe know a lot, and they are not acting as they should. My doctor was not one of them. He will be a victim too when full enlightenment about these drugs becomes the norm and he realizes how many people he hurt. Rather than hate him for what he did I see him more as one might see a pure accident, like an asteroid hitting me and hurting me. S—t happens to people, it’s how this place works. It’s probably good to accept that about this planet and then try all we can to make it better.”

Cathy: ” I have set an example for my kids of what true strength looks like.”

Lisa: “I am alive. Cipro was one of the few antibiotics that does not result in anaphylactic shock for me. It was used to treat a super bug I contracted after cancer surgery. I suppose that is why I am able to reconcile my current situation easier than others might.”

Bill: “Nope. No upside whatsoever. I was fine before and now still trying to get back to baseline. The “best thing that ever happened to me” thing is just an attempt at a cognitive reframe for the traumatic event….helps put it behind you. If it works for ya-great. If something good came as a result of your poisoning—again…great.”

Langdon: “Compassion for myself and appreciation for the people who are nice to me.”

Jennifer: “For sure Levaquin wasn’t the worst thing that’s ever happened to me but it was up there with the top 3 worst. The only good thing that came out of it is it forced me to alter my life and change my diet pretty drastically. I now lead a more healthy lifestyle eating 85-95% organic, way way less refined sugars & processed foods. Additionally, I am trying to lessen the toxins coming into my household by buying mostly cleaning and skincare products that are free of toxic chemicals. Of course it’s not 100% but I’ve made great strides. I’m not sure if I would’ve been on this trajectory had it not been for Levaquin. I was always health conscious but now it’s on another level. I feel like it’s life or death or at least life or really poor health. I truly grasp the concept of “if you don’t have your health you have nothing”. It’s so difficult to do anything (or care for anything) when your health is suffering so badly. I am grateful every day that I’m recovering from this nightmare and I wish everyone here the best. Healing hugs.”

Each and every one of those quotes/comments is thoughtful, insightful, and contains gems of wisdom. Thank you to each person who took the time to write these thoughtful comments, and for allowing me to re-publish them here.

Again, I am not trying to make light of the horror of fluoroquinolone toxicity. It’s not a trite, “make lemonade out of lemons” kind of situation. But I do appreciate all that has grown from the manure that ciprofloxacin brought to my life, and I hope for something positive to come of it for each of you too.

*****

 

The A to Z of Fluoroquinolone Toxicity Syndrome

The following was written by Kim Jansen. You can read Kim’s story of fluoroquinolone toxicity HERE

If you are interested in writing a guest-post for floxiehope.com, please let me know. Here is a post with more information about writing for floxiehope.

Here is a version of this post that is easier to read and print. It’s a great overview of fluoroquinolone toxicity to give to your loved-ones. The A to Z of Fluoroquinolone Toxicity Syndrome

The A to Z of Fluoroquinolone Toxicity Syndrome

A. Antibiotic. Fluoroquinolones are a family of broad-spectrum antibiotics that are commonly used to treat a variety of illnesses such as respiratory and urinary tract infections. Types of fluoroquinolones (along with their brand-names in brackets), include: ciprofloxacin (Cipro); levofloxacin (Levaquin); moxifloxacin (Avelox); gatifloxacin (Tequin); ofloxacin (Ocuflox/Floxin/Floxacin); norfloxacin (Noroxin). These antibiotics have serious side effects, with the term ‘fluoroquinolone toxicity syndrome’ being used to refer to the condition experienced by those who suffer from these side effects.

B. Bayer. Bayer is a pharmaceutical company that manufactures Cipro and Avelox. Bayer is currently facing a new lawsuit from a complainant, who has been diagnosed with peripheral neuropathy (see ‘Nerve Damage’ entry below) since 2011. She alleges that Bayer knew that Cipro could cause chronic or permanent peripheral neuropathy soon after receiving FDA (U.S) approval in 1987. By 1988, the drug companies possessed at least one published case report that constituted a safety “signal” that fluoroquinolones were associated peripheral nerve damage and that further investigation and study were necessary to protect patients. Since then, numerous other studies have affirmed this connection. This complainant’s Cipro lawsuit joins hundreds of other fluoroquinolone toxicity claims pending against manufacturers of fluoroquinolone antibiotics.

C. Central Nervous System Damage. Fluoroquinolones are able to penetrate the blood brain barrier, thus also able to damage a person’s central nervous system . The FDA in America acknowledged this fact and placed a warning about potential CNS damage on fluoroquinolone medication (see ‘FDA Warnings’ entry below). Some of the side effects of CNS damage include insomnia, restlessness, seizures, convulsions, and psychosis. An extensive collaborative investigation by scientists and member of a social network in 2016 found that 93 of 94 respondents of a survey reported fluoroquinolone-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of fluoroquinolone initiation or days to months of fluoroquinolone discontinuation. They also discovered that mice treated with ciprofloxacin had lower grip strengths, reduced balance, and depressive behaviour compared with the controls.

D. DNA Damage. Fluoroquinolones work by inhibiting the replication of bacterial DNA. Tests have shown that these antibiotics also damage healthy DNA, including mitochondrial DNA. This is one of the likely reasons why the damage caused by fluoroquinolone toxicity affects multiple body systems and is persistent.

E. EMA. Public Hearing. In June 2018, the EMA (European Medicines Agency) held a public hearing to discuss the serious health concerns surrounding side effects of quinolones and fluoroquinolones. On 15 November 2018, EMA finalised a review of serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018. Here is an excerpt from the press release of their findings:
EMA’s human medicines committee (CHMP) endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended. The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.

F. FDA Warnings. The U.S. Food and Drug Administration has issued a series of warnings over the last number of years regarding serious and potentially permanent adverse side effects of fluoroquinolones, including a ‘Black Box’ warning (its strongest warning possible) in 2008, which it has upgraded numerous times since. A summary of the warnings is below:
a. 2008 – increased risk of tendinitis and tendon rupture.
b. 2011 – fluoroquinolones may have neuromuscular blocking activity.
c. 2013 – the potential for irreversible peripheral neuropathy (serious nerve damage).
d. 2016 – disabling and potentially permanent serious side effects that can occur together which may involve the tendons, muscles, joints, nerves, and central nervous system.
e. 2018 (July) – may cause significant decreases in blood sugar, potentially resulting in coma, as well as certain mental health side effects, including disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.
f. 2018 (December) – the risk of aortic aneurysm and dissection.
Fluoroquinolones are now deemed to be a ‘drug of last resort’ in the U.S for most infections. The clinical guidelines in Australia, whilst not quite as strong, clearly indicate that fluoroquinolones should be reserved for serious bacterial infections for which an alternative treatment is not available. The reality of over-prescription and lack of physician awareness of the side effects of fluoroquinolones indicate a significant disconnect between the official regulatory bodies and current medical practice.

G. Glutathione. Glutathione is an important antioxidant. It is comprised of three amino acids (cysteine, glutamic acid, and glycine) present in most mammalian tissue. Glutathione also acts as a free radical scavenger and a detoxifying agent. A 2011 study found that the fluoroquinolone antibiotic Ciprofloxacin causes a significant decrease in glutathione levels in the body (a 25.5% decrease in levels by the fifth day of treatment.) . The reduction of glutathione in the body caused by fluoroquinolones is likely to be a contributing factor to the oxidative stress (see ‘Oxidative Stress’ entry below) caused by fluoroquinolones. Tests conducted on rats also revealed administering Ciprofloxacin resulted in a significant decrease in glutathione content in the liver.

H. Heart Damage. Due to its collagen-depleting mechanism, fluoroquinolones can cause serious damage to the heart. The U.S FDA released a warning in December 2018, stating that patients should avoid fluoroquinolone antibiotics due to an increased risk of heart-vessel tears. ‘These tears,’ it stated, ‘called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death’.

I. Income loss. One of the all-too frequent associated impacts of fluoroquinolone toxicity is the sufferer’s inability to continue in paid employment. There are many media and online stories where people share the devastating impact this drug has had, not just on their health, but on their family relationships, their livelihood and their ability to be financially independent. One such news story is footnoted here.

J. Johnson & Johnson. Johnson & Johnson’s Janssen Pharmaceuticals unit discontinued production of the fluoroquinolone antibiotic Levaquin in December 2017, amid growing concerns over the serious side effects and complications potentially associated with the use of fluoroquinolone antibiotics. Another likely reason for this discontinuation by Johnson & Johnson is due to its having lost millions of dollars in previous lawsuits over Levaquin, (including settling 845 lawsuits over Levaquin in 2012) . There are still hundreds of individuals waiting to have their cases heard over debilitating injuries caused by Levaquin and other fluoroquinolones, which is another likely reason for Johnson & Johnson’s decision. Johnson & Johnson’s decision to cease manufacturing this drug does not constitute a product recall, with the drug still being available with the J&J brand until 2020 and generic versions of the drug continuing indefinitely at this stage.

K. Kidney Damage. Fluoroquinolone antibiotics can cause kidney damage including renal failure. A 2013 study found a twofold increased risk of acute kidney injury requiring hospital admission with the use of fluoroquinolone antibiotics among adult men.

L. Levaquin. Levaquin is the brand name of a type of fluoroquinolone antibiotic manufactured by Janssen Pharmaceutical (see ‘Johnson & Johnson’ entry above). The drug’s scientific name is levofloxacin. Levaquin has been the subject of hundreds of lawsuits by patients who have suffered debilitating side effects from this drug.

M. Mitochondrial Toxicity. The mitochondria are rod-shaped organelles that are the ‘power generators’ of cells, ‘turning sugars, fats and proteins that we eat, into forms of chemical energy that the body can use to carry on living’. Fluoroquinolones damage mitochondrial DNA, resulting in a range of disabling symptoms in sufferers, including pain, weakness and fatigue.

N. Nerve Damage. Many sufferers of fluoroquinolone toxicity syndrome experience nerve damage, often resulting in peripheral neuropathy. Peripheral neuropathy is a condition in which the nerves in the peripheral nervous system become damaged. Usually the disorder affects the nerves that provide sensation, which causes pain, tingling, and burning symptoms of the nerves affected, frequently, but not limited to, the hands and feet. The U.S. Food and Drug Administration enhanced its warnings of fluoroquinolone side effects in 2013 to include ‘the potential for irreversible peripheral neuropathy’.

O. Oxidative Stress. ‘Oxidative stress occurs when excess oxygen radicals are produced in cells, which could overwhelm the normal antioxidant capacity. [Oxidative stress can lead to damage of] proteins, lipids, and DNA, which could lead to cytotoxicity, genotoxicity, and even carcinogenesis when damaged (mutated) cells can proliferate.’ A scientific study conducted in 2011 demonstrated that fluoroquinolone antibiotics are a significant cause of oxidative stress, with tests revealing this stress was ‘greatest 5 days after exposure to ciprofloxacin and levofloxacin therapy, which indicates the formation of reactive oxygen species as in previous studies with fluoroquinolones. These results [were] further supported by [a] decrease in plasma antioxidant status by 77.6% and 50.5% for ciprofloxacin and levofloxacin respectively’24. They concluded their report with the finding that ‘[t]here was a considerable increase in lipid peroxide levels indicating an enormous oxidative stress’ in patients taking fluoroquinolones and suggested that increase in oxidative stress may be responsible for the pathological mechanism of tendinitis (see ‘Tendon Ruptures’ entry below).

P. Pain. Pain is often (but not always) the first symptom fluoroquinolone toxicity sufferers experience. This can occur after the first dose taken. The pain usually begins in the legs or feet before spreading to other parts of the body. The pain will often be constant and remain for months or years. Pain in joints, hands, feet, tendons and nerves (see ‘Nerve Damage’ entry above) is common, ranging in severity from a dull ache to, extreme, sharp, unbearable pain. Many case studies document patients living with extreme, ongoing pain that cannot be medically managed.

Q. Quinolones. Quinolones are an earlier generation of the current fluoroquinolone family of antibiotics (although quinolones are still in limited use). A fluorine atom was added to the quinolone’s central ring system, thus creating fluoroquinolones, which have proven to be more effective in disrupting bacterial DNA than the quinolone form of the antibiotic.

R. Relapse. Many sufferers of fluoroquinolone toxicity syndrome report (often multiple) relapses of their symptoms, sometimes years after the initial onset of their illness. This is likely due to the multi-system, cellular and oxidative-stress nature of this toxicity. Sometimes a relapse can be caused by a specific trigger, such as the subsequent use of NSAIDs (such as ibuprofen) or steroid medications.

S. Suicide. There have been thousands of reported cases of deaths linked to fluoroquinolone toxicity (over 6500 to the end of 2015 in the U.S alone). This number, however, does not include the large number of people who have taken their own lives after experiencing sudden and extreme mental health side effects from fluoroquinolones. A group of doctors wrote an article for the European Journal of Internal Medicine in which they report on the concerning number of suicides or attempted suicides by patients on fluoroquinolone antibiotics. They cite that in the United States, 40% of reported fluoroquinolone-related suicide events occurred within two weeks of taking fluoroquinolone medication. Many of these patients had no previous mental health issues.

T. Tendon Ruptures/Tendonitis. One of the most common adverse side effects of fluoroquinolones is tendon damage, including tendon ruptures, frequently to the Achilles tendon. This is due to a combination of factors, including fluoroquinolones being responsible for destroying collagen (collagen is a major component of tendons). A study in 2015 investigated the impact of fluoroquinolones on collagen and discovered that fluoroquinolones ‘were associated with almost a tripling of the risk of tendon ruptures—a recognised collagen-associated adverse event induced by these medications.’ Perhaps of even greater concern was their finding that ‘fluoroquinolones were associated with a similar increase in the risk of aortic aneurysms.’

U. Under-reporting. It is almost certain that fluoroquinolone toxicity is under-reported. Drug safety professionals estimate that only 10% of adverse events (across all drugs) are reported to the FDA every year, in part due to physicians having no requirement or incentive to report adverse reactions. It is highly likely that the rate of adverse reaction reporting for fluoroquinolone antibiotics is lower still, for the following reasons:
a. The noticeable symptoms of fluoroquinolone toxicity can take months to manifest, thus making it more likely that the patient does not connect their ‘new’ symptoms with a course of fluoroquinolone antibiotics they took previously.
b. Many medical practitioners are still unaware of, or refuse to acknowledge, the damage that fluoroquinolone antibiotics can cause. This is evidenced in the frequency with which these antibiotics are prescribed for uncomplicated (suspected) infections when safer alternatives are available. As one report states: ‘Despite these seemingly significant numbers and overwhelming reports from patients, physicians continue to prescribe fluoroquinolone antibiotics unsystematically, against US Food and Drug Administration recommendations. Thus, adverse reactions to fluoroquinolones are often not reported by physicians, nor by the patient themselves. Even though significant under-reporting is extremely likely, there are over 200,000 reported cases of adverse reactions to fluoroquinolone antibiotics in the U.S alone, tens of thousands of these being serious and over 6,000 reported deaths. 1,498 cases of adverse reactions to Ciprofloxacin have been submitted to Australia’s Therapeutic Goods Administration (up to 18 January 2019).

V. Vitamins and Minerals. There is no quick cure or treatment for fluoroquinolone toxicity. Healing plans usually focus on rest and a diet/supplement regime which aims to replenish those essential elements that have been depleted or damaged by the drug. One of the most important mineral supplements is magnesium. This is because fluoroquinolones deplete magnesium from the body and also because toxicity from fluoroquinolones is reduced by the supplementation of magnesium (as proven through tests conducted on both humans and rats).

W. Weakness and Fatigue. Alongside pain, muscle weakness and fatigue are often the first symptoms fluoroquinolone toxicity sufferers experience. The weakness is likely a result of the cellular damage caused by the drug, including damage to the mitochondria in the cells (see ‘Mitochondrial Toxicity’ entry above). As a consequence, many sufferers are (mis)diagnosed with CFS/ME (Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis).

X. The X Factor (the unknowns). Scientists and medical professionals are still discovering all the ways in which fluoroquinolones adversely affect the body and mind. Much is still unknown about the long-term impacts of this drug. One of the more frightening discoveries in recent years is the likelihood that fluoroquinolone toxicity sufferers are at a significantly higher risk of developing Parkinson’s Disease and Alzheimer’s due to the long-term oxidative stress caused by this drug and by the damage it causes to the cells’ mitochondria (see ‘Oxidative Stress’ and ‘Mitochondrial Toxicity’ entries above). In 2014, A U.S. medical practitioner, Charles Bennett, who has conducted a great deal of research on fluoroquinolone toxicity, filed a citizen’s petition with the FDA seeking to expand the black box warning to include mitochondrial toxicity as one of its side effects, with the concern that it can lead to Parkinson’s Disease and Alzheimer’s.

Y. Years. People who suffer from fluoroquinolone toxicity often take years to recover, whilst others experience little improvement in their symptoms, even years after first suffering toxicity (as evidenced by some of the speakers at the EMA public hearing in June 2018).

Z. ZZZZ (sleep). The European Medicines Agency’s 2018 public hearing and investigation into fluoroquinolones concluded that sleep problems (including nightmares and insomnia) were among the many long-term side effects of fluoroquinolone toxicity. Sadly, much of the medical profession world-wide seems to have no trouble being asleep to the dangers of fluoroquinolones, with doctors continuing to prescribe this drug in the millions each year for uncomplicated health conditions where safer, as effective antibiotics are available. Patients also continue to report having been prescribed fluoroquinolones without being given any information about the risk of serious, potentially permanent, side effects.

References:

  1. The Marshall Protocol Knowledge Base. “Fluoroquinolone Antibiotics”: https://mpkb.org/home/othertreatments/antibacterials/fluoroquinolones
  2. Arentz Law Group. “Cipro Lawsuit Alleges Bayer Actively Concealed Irreversible Peripheral Neuropathy Risks.” https://arentzlaw.com/defective-drug/cipro-lawsuit-peripheral-neuropathy/
  3. Dr Joseph Mercola. “Antibiotic Alert: The Drug the Doctor Ordered Could Cause Deadly Side Effects.”
    https://articles.mercola.com/sites/articles/archive/2012/10/20/fluoroquinolones-side-effects.aspx
  4. Oncology Practice. “Fluoroquinolone-related neuropsychiatric and mitochondrial toxicity: a collaborative investigation by scientists and members of a social network.” https://www.ncbi.nlm.nih.gov/pubmed/26955658
  5. Nucleic Acids Research. “Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase-2.” https://academic.oup.com/nar/article/46/18/9625/5088042
  6. European Medicines Agency. “Quinolone- and fluoroquinolone-containing medicinal products – European Commission Final Decision.” https://www.ema.europa.eu/en/medicines/human/referrals/
    quinolone-fluoroquinolone-containing-medicinal-products
  7. FDA Drug Safety Communication. “FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects.” https://www.fda.gov/drugs/drugsafety/ucm511530.htm
  8. U.S. Food and Drug Administration. “FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections”. https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm
  9. U.S National Library of Medicine. “Glutathione.” https://pubchem.ncbi.nlm.nih.gov/compound/glutathione
  10. Journal of Young Pharmacists. “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/
  11. Drug and Chemical Toxicology. “Ciprofloxacin‐Induced Glutathione Redox Status Alterations in Rat Tissues.” https://www.tandfonline.com/doi/abs/10.1081/DCT-120037504?journalCode=idct20
  12. Medical Xpress. “Certain antibiotics tied to deadly heart vessel tears: FDA.”
    https://medicalxpress.com/news/2018-12-antibiotics-tied-deadly-heart-vessel.html
  13. Al Jazeera. “Left paralysed from Fluoroquinolone antibiotic toxicity.”
    https://www.aljazeera.com/indepth/features/2017/09/left-paralysed-fluoroquinolone-antibiotic-toxicity-170919135407632.html
  14. RX Injury Help. “Janssen Discontinued Levaquin Production as Concerns Over Fluoroquinolone Side Effects Grow.” https://www.rxinjuryhelp.com/news/2018/07/18/janssen-discontinued-levaquin-production-as-concerns-over-fluoroquinolone-side-effects-grew/
  15. Drug Injury Law: Medical and Legal Information. “Johnson & Johnson settles 845 Levaquin Lawsuits.” https://www.drug-injury.com/drug_injury/2012/11/johnson-johnson-settles-845-levaquin-lawsuits.html
  16. Arentz Law Group. “Levaquin pulled from market to avoid lawsuit.”
    https://arentzlaw.com/defective-drug/jj-stops-levaquin-sales/
  17. Canadian Medical Association Journal. “Risk of acute kidney injury associated with the use of fluoroquinolones.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3708027/
  18. Thomas J Henry Law. “Johnson & Johnson Settles Levaquin Lawsuits”. https://thomasjhenrylaw.com/blog/dangerous-drugs-devices/johnson-johnson-settles-levaquin-lawsuits/
  19. Mitochondrial Biology Unit. http://www.mrc-mbu.cam.ac.uk/what-are-mitochondria
  20. Oncology Practice. “Fluoroquinolone-related neuropsychiatric and mitochondrial toxicity: a collaborative investigation by scientists and members of a social network.” https://www.mdedge.com/hematology-oncology/article/106661/patient-survivor-care/fluoroquinolone-related-neuropsychiatric
  21. Journal of Investigative Medicines: “Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528905/
  22. Medicine Net. “Peripheral Neuropathy Causes, Symptoms, and Treatment Medications.” https://www.medicinenet.com/peripheral_neuropathy/article.htm#peripheral_neuropathy_definition_and_facts
  23. Science Direct. “Oxidative Stress.” https://www.sciencedirect.com/topics/neuroscience/oxidative-stress
  24. Journal of Young Pharmacists: “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/
  25. Journal of Pain & Palliative Care Pharmacotherapy. “Intractable Acute Pain Related to Fluoroquinolone-Induced Peripheral Neuropathy.” https://www.ncbi.nlm.nih.gov/pubmed/28358229
  26. US National Library of Medicine. “Fluoroquinolone-induced serious, persistent, multisymptom adverse effects.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4600819/
  27. US National Library of Medicine. “Fluoroquinolones interactions with nonsteroidal anti-inflammatory drugs.” https://www.ncbi.nlm.nih.gov/pubmed/15176310
  28. European Medicines Agency. “EMA public hearing on quinolones and fluoroquinolones.” https://www.ema.europa.eu/en/documents/other/public-hearing-quinolone-fluoroquinolone-written-interventions_en.pdf
  29. Nature. “When antibiotics turn toxic.” https://www.nature.com/articles/d41586-018-03267-5
  30. European Journal of Internal Medicine. “Fluoroquinolone-associated suicide.” https://www.ejinme.com/article/S0953-6205(18)30284-X/fulltext
  31. The Journal of Clinical and Aesthetic Dermatology. “The Risk of Fluoroquinolone-induced Tendinopathy and Tendon Rupture.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2921747/
  32. BMJ Journals. “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study.” https://bmjopen.bmj.com/content/5/11/e010077
  33. PSQH: Patient Safety and Quality Healthcare. “A Closer Look at FDA’s Adverse Event Reporting System.” https://www.psqh.com/analysis/a-closer-look-at-fdas-adverse-event-reporting-system/
  34. Oxidative Medicine and Cellular Longevity. “Treatment of the Fluoroquinolone-Associated Disability: The Pathobiochemical Implications.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632915/
  35. Journal of Investigative Medicine. “Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528905/
  36. Therapeutic Goods Administration (Australia) Database of Adverse Event Notifications – medicines https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx
  37. American Society for Microbiology. “Diminished Ciprofloxacin-Induced Chondrotoxicity by Supplementation with Magnesium and Vitamin E in Immature Rats.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1803142/
  38. ME Association UK. “Update: MHRA issues new restrictions and precautions for Fluoroquinolone antibiotics 29 March.” https://www.meassociation.org.uk/2019/03/update-mhra-restrictions-and-precautions-for-fluoroquinolone-antibiotics-28-march-2019/
  39. CBS Chicago. “Safety Advocate: Powerful Antibiotics Being Overprescribed.”
    https://chicago.cbslocal.com/2015/03/11/safety-advocate-powerful-antibiotics-being-overprescribed/
  40. European Medicines Agency. “Public Hearing on quinolone and fluoroquinolone antibiotics” .
    https://www.youtube.com/watch?v=1vao8o5NGUc
  41. European Medicines Agency. “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics.” https://www.ema.europa.eu/en/news/disabling-potentially-permanent-side-effects-lead-suspension-restrictions-quinolone-fluoroquinolone

******

The Term “Flox”

When I tell people about this site they often ask me what the terms flox, floxed, and floxie mean. I am not a lexicographer by any stretch, and these are not official definitions, but here are my answers:

Flox (noun): A shorthand term for the multi-symptom, chronic illnesses brought on by fluoroquinolone antibiotics that are referred to as Fluoroquinolone toxicity or Fluoroquinolone Associated Disability (FQAD).

Flox (verb): To be afflicted with fluoroquinolone toxicity or FQAD. The term “flox” is typically used in the past tense as “floxed,” as in, “I was floxed by cipro in 2011.”

Floxie (noun): A person who suffers from fluoroquinolone toxicity or FQAD.

The term “flox” comes from the names of the fluroquinolone antibiotics. All the fluoroquinolones contain “flox” in their names – ciproFLOXacin, levoFLOXacin, moxiFLOXacin, gatiFLOXacin, oFLOXacin, etc. As communities of victims of these drugs formed, people found it easier to say, “I’ve been floxed” or, “I’m a floxie” than to say, “I am going though a multi-symptom illness brought on by fluoroquinolone antibiotics.” Perhaps the term “FQAD” would have been just as easy to say as “flox,” but “flox” preceded “FQAD” by more than a decade and the term has stuck.

The earliest written record of the term “flox” that I can find is in Stephen Fried’s 1998 bestselling book, “Bitter Pills: Inside the Hazardous World of Legal Drugs.” In it, Fried describes his wife’s severe, primarily psychiatric, adverse reaction to ofloxacin, a fluoroquinolone antibiotic. Fried noted that the community of people who had been hurt by this class of drugs referred to themselves as “floxies” and spoke of their condition as being “floxed.” (EDIT/NOTE – Please see Mr. Fried’s comment below for correct information about the early usage of the term “flox.)

Most journal, and even news, articles don’t use the terms “flox” or “floxie.” They typically refer to the constellation of symptoms that “floxies” deal with as “adverse reactions to fluoroquinolone antibiotics” or they don’t refer to the syndrome as a whole at all, rather, they’ll list the symptoms that their featured victim suffers from, and then note that the victim attributes those symptoms to fluoroquinolone antibiotics. A couple news articles have used the term FQAD, as it was coined by the FDA, and is seen as a bit more official than “flox.”

In online communities new terms are often coined, and they gain traction in those communities. “Flox” is one of those terms. The terms “flox” and “floxie” are primarily used on the internet in support groups for victims of fluoroquinolones. The biggest Facebook group for victims of fluoroquinolones is The Fluoroquinolone Toxicity Group, and their url is https://www.facebook.com/groups/floxies/ (note the “floxies” in the url – it’s easier than https://www.facebook.com/groups/FluoroquinoloneToxicityGroup). Additionally, this site is one of the more popular blogs about fluoroquinolones, and it’s called Floxie Hope. The terms “flox” and “floxie” are used throughout blogs and support groups dedicated to fluoroquinolone toxicity.

People within the “floxie” groups and communities know these terms and what they mean and imply. The people in the “floxie” community know when someone says that they are “severely floxed” that it means that person is suffering from more symptoms than they can count or name and that they are likely bed or house bound as a result of their fluoroquinolone-induced injuries. Of course, everyone’s experience is different, and people are encouraged in these communities to further describe their pain and their experience, but it’s far easier to say, “I’m severely floxed” than it is to list dozens of symptoms then say that those symptoms were caused by fluoroquinolone antibiotics.

Some people really hate the terms “flox” and they particularly hate the term “floxie.” They see the terms as silly and flippant, and they see it as disrespectful to those who are suffering from fluoroquinolone toxicity. Fluoroquinolone toxicity IS a serious and severe illness, and it should be taken seriously by doctors, patients, regulators, and everyone else. It is not a joke, or something to be taken lightly. It is a life-altering, often disabling, syndrome. Fluoroquinolones have maimed and killed people, and fluoroquinolone toxicity should be taken as seriously as other multi-symptom, chronic, mysterious illnesses like M.S., Lupus, Lyme Disease, M.E./CFS, etc.

Neither “flox” nor “floxie” are particularly serious terms, and I empathize, and even agree with, those who see it as minimizing the seriousness and severity of fluoroquinolone toxicity.

But… sometimes terms just stick. Both flox and floxie are terms that have resonated with people in the community, and they have stuck. Many people find it easier to describe their illness as being “floxed” than to describe it any other way. It resonates with people more to say, “floxies unite!” than it does to say, “victims of fluoroquinolone antibiotics come together!” For the purposes that the the terms are used, they work well for expressing what people want and need to say. I don’t think that anyone who uses the terms “flox” or “floxie” mean any disrespect to the illness or the people suffering from it. In fact, most of the people using the terms are either victims of fluoroquinolones or those who love a victim of fluoroquinolones.

I am writing this post on a site called Floxie Hope, so I am, of course, somewhat biased. I like the term “floxie” and it has become part of my brand (if you can say that a blog has a brand). I think that the term sticks in people’s minds and it resonates with them. There is an understanding of what it means–at least within our community. The naming of this site was somewhat accidental–I was trying to figure out how to create a web site and this was supposed to be my place-holder site until I figured out the mechanics of blogging, then I was supposed to think of a more well thought out name for the official site, but then this site got rolling while named Floxie Hope, and 5.5 years later, it’s still going and here we are.

I hear the people who think that “flox” and “floxie” aren’t serious enough terms to connote the severity of fluoroquinolone toxicity. In a lot of ways, I think they’re right. BUT, I don’t think that the term has held this community back. We have made a lot of progress over the last decade. We still have a lot of work to do, but millions of people have become aware of fluoroquinolone toxicity and fluoroquinolone dangers over the last decade, and part of the momentum of this community is our shared language and our shared understanding of terms like “flox.”

The terms “flox” and “floxie” are ingrained in our community, and they are likely here to stay as long as fluoroquinolones are hurting people (I hope for the extinction of the term through the strict limiting of the drugs – but we’re a long way from that and it’s certainly a matter for another post). I think that the terms are doing more good (through ease of communication, bringing people together, and having terms that resonate with many) than harm.

I am hopeful that the terms “flox” and “floxie” will someday be so well understood and accepted that they make it into the dictionary. The only criteria for words making it into the dictionary is that they appear in edited text, so I actually hope that more journalists start using the terms “flox” and “floxie” in their articles. Having the terms “flox” and “floxie” in the dictionary would be wonderfully validating, and it would help to increase awareness of fluoroquinolone toxicity.

When I describe this site, I often try to tell the back-story and give the long explanation of how I was hurt by ciprofloxacin. Sometimes the person who I’m talking to says something like, “Oh, you’ve been floxed – that happened to my sister-in-law.” The word is getting out, and the terms “flox” and “floxie” are spreading. It’s a good thing. Awareness is one of the most important steps toward change, and short, easy-to-remember terms like “flox” and “floxie” help people to become aware of the dangers of fluoroquinolones.

*****

NY Resolution to Heal My Gut

Seven years after I got floxed, and 5.5 years since I wrote my recovery story, I am still doing well. I am working at a job that I enjoy, I am in a good relationship, I can hike, bike, swim, and otherwise move my body, I have my reading comprehension and intellect back, my energy level is decent, and my autonomic nervous system generally operates as it’s supposed to. I feel good, and I’m living a good life. As I’ve said many times before, I hope that my recovery gives you hope for your healing.

With it noted that I’m generally healed, and that I feel good in most areas of my life, I’m going to confess that…

My gut is a mess, and I am worried about it.

I have no idea whether my gut issues are from being floxed or not. GI tract problems weren’t part of my initial floxing–I didn’t have any gut issues until recently. But in the last year(ish), my gut has started to have… issues. Unfortunately, there is no way to describe GI issues without describing bowel movements, so here goes – I haven’t had a normal textured poo in ages. It has been at least a year. TMI? Sorry.

Poorly formed stools are definitely a sign of inflammation and other gut issues, and, despite the fact that I feel generally okay, I’m concerned about my gut health.

I want a gut that doesn’t hurt every day, that forms healthy-textured poos, and that I don’t worry about. I don’t want to be concerned that I’m developing IBS, or crohn’s disease, or that I have c-diff, or anything else. I’m guessing that I don’t have any of those things, and that I just have an inflamed gut, but I don’t want that either. I want a healthy, happy, healed gut that feels good and operates entirely normally. I don’t think that’s too much to ask for. I also think that my gut is my responsibility, and that no one other than me can do anything about MY gut health.

It’s December 28th as I write this, and the beginning of the new year seems as good a time as any to commit to healing my gut. Here are some of the things I plan to do to heal my gut in 2019 (public accountability is good, right?):

Clean up my diet

When I first got floxed I ate only meat and veggies. I was scared of most foods, and I ended up losing weight and feeling worn-down because I wasn’t ingesting enough calories. After I got over the fear of food, I added fruits and other good things to my diet, and ended up eating as outlined in The Floxie Food Guide. But, after a while of feeling better, I stopped restricting my diet entirely. I didn’t eat much processed food because I’ve never liked processed food, but I ate whatever I wanted. Perhaps my GI issues are the result of my “anything goes” diet (or maybe my GI issues stem from something else like mold in my house or fluoride in my city’s water or a parasite – it’s hard to tell). Anyhow, it’s time to restrict my diet again with the hope of calming the inflammation in my intestines.

Step 1: Give up gluten. My husband has been on a bread-baking kick lately, so this will take some willpower, but it has helped so many people, and it seems like a logical first step, so, I’m going to go gluten-free and see if that helps.

Step 2: Give up legumes. I like beans, but they make me feel like crap.

Step 3: Limit dairy. I love dairy too much to say that I’m going to give it up, but I’m going to try to be cognizant of how much I eat and how it makes me feel and limit it.

I want to be able to sustain these changes, so these are the only things I’m going to do at first. If they don’t work, I’ll move on to a more restricted protocol – probably something close to The Wahls Protocol because it has helped so many fellow “floxies.”

I’ve noticed that oatmeal makes me feel better generally, so I’m going to eat more oatmeal. I’ve also noticed that spicy food tends to make me feel worse, so I’m going to limit them even though many spices are supposed to be anti-inflammatory.

Cut the coffee and alcohol

This is a no-brainer, right? No explanation is necessary as to why these need to go in order for me to heal my gut. It’s hard though, so, here’s my public accountability.

Note that the coffee I drink is decaf. I haven’t been able to tolerate caffeinated coffee post-flox.

I really like both coffee and alcohol, and this is going to be tough. I’m only committing to cutting down on them, not to completely giving up either, but I can commit to cutting the coffee by 50% and the alcohol by 80%.

Eat probiotic foods

Sauerkraut and kimchi, here I come. Luckily, I like both.

Meditate, breathing exercises, eat mindfully, and otherwise stimulate the vagus nerve to heal the gut

Our guts are connected to our brains via the vagus nerve, and stimulating and toning the vagus nerve through meditating, breathing exercises, mindfulness, and other activities, can heal both the gut and the brain.

Here is an interesting post about how a guy healed his IBS through stimulating his vagus nerve through gargling: How I Cured My Irritable Bowel Syndrome.

As I was going through the early stages of my fluoroquinolone toxicity journey I was really good about meditating, doing breathing exercises, going to the chiropractor and/or acupuncturist, and doing other things that stimulated my vagus nerve. I think that these things helped me to heal. They were part of my healing journey, and I recommend them to others because they are healing for the body, mind, and spirit, and because they stimulate the vagus nerve and trigger the release of acetylcholine. Like watching my diet, conscientiously doing activities that stimulated my vagus nerve fell to the wayside as I healed. I felt good, so I didn’t need to do breathing exercises to feel better. But, I think that all the vagus nerve healing exercises were helpful for my gut when I was doing them, and that they’ll be helpful for my gut if I do them again.

Shoot, I wrote a book about healing the vagus nerve – I should make the time to practice what I preach.

Step 1: Meditate daily

Step 2: Swim weekly – it forces breathing exercises, and movement is good for the vagus nerve.

Step 3: Eat mindfully

Step 4: Gargle and/or hum daily

 

Those are my resolutions, and I hope that they result in a happier, healthier gut.

I’m open to suggestions for gut healing. Please feel free to comment below to let me know what has helped you to heal your gut. As you may gather from the post above, I am not willing to go on a super-restrictive diet unless/until all else fails, but I am willing to hear suggestions. I’m also open to trying supplements that heal the gut including aloe juice, collagen, bone broth, probiotic supplements, etc. If you have any recommendations based on personal experience with gut-healing supplements, please comment below.

Whenever someone asks in the forums about how to heal from fluoroquinolone toxicity, someone always answers, “heal your gut.” They’re right, of course–but it’s easier said than done. There are people in the “floxie” community who are much more better about having a “clean” diet than I am who still struggle with GI issues and other symptoms of fluoroquinolone toxicity. I’m hopeful that my modified “clean-ish” diet will help my gut to heal, and that the other things mentioned above help too. I want to acknowledge though, that “healing the gut” is not simple and that there isn’t a single answer for how to do it. I’m hopeful that the steps noted above will help me, and that I’ll have a healthier, happier gut in 2019 than I did in 2018.

*****

 

 

 

 

FDA Warns About Increased Risk of Aortic Aneurysm and Dissection with Fluoroquinolone Antibiotics

On December 20, 2018, the US FDA released a review that “found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.” (source)

This acknowledgement from the FDA came three years after two major studies showed a statistically significant increase in risk of aortic dissection and aneurysm with fluoroquinolone use. The studies, “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” (JAMA Internal Medicine, 2015), and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” (BMJ Open, 2015) both found that fluoroquinolone use is associated with an increased risk of aortic aneurysm and dissection, with “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” concluding that:

“Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection. While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”

Both “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” are major studies, with “analysis of 1477 case patients and 147 700 matched control cases from Taiwan’s National Health Insurance Research Database (NHIRD) from among 1 million individuals longitudinally observed from January 2000 through December 2011” for the former, and 1.7 million older adults in Ontario, Canada, for the later. They are robust studies that show a statistically significant association between fluoroquinolone-use and aortic aneurysm and dissection.

The FDA took too long to warn the public about the dangers of aortic aneurysm and dissection post exposure to fluoroquinolones, but, better late than never. Here is the full text of the FDA announcement that was published on Thursday December 20, 2018:

[12-20-2018] A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available.  People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.  We are requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.

Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

Health care professionals should avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.  Prescribe fluoroquinolones to these patients only when no other treatment options are available.  Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.  Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.  Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.  Before starting an antibiotic prescription, inform your health care professional if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.  If you have been prescribed a fluoroquinolone to treat an infection, do not stop the antibiotic without first talking to your health care professional.

We reviewed cases reported to FDA* and four published observational studies1,2,3,4 that showed an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use (see Data Summary).  How some of the studies were designed or carried out, and the ways the data were analyzed could affect the study findings; however, taken together, the results of all four studies provide consistent evidence of an association between fluoroquinolone use and aortic aneurysm or dissection.  The underlying mechanism for this risk cannot be determined from these studies, and the background risk of aortic aneurysm can vary depending on the population.  The background risk has been estimated from nine aortic aneurysm events per 100,000 people per year in the general population to 300 aortic aneurysm events per 100,000 people per year in individuals at highest risk.  Because multiple studies showed higher rates of about twice the risk of aortic aneurysm rupture and dissection in those taking fluoroquinolones, FDA determined the warnings were warranted to alert health care professionals and patients.

We communicated safety information associated with fluoroquinolones in July 2018 (significant decreases in blood sugar and certain mental health side effects), July 2016 (disabling side effects of the tendons, muscles, joints, nerves, and central nervous system), May 2016 (restricting use for certain uncomplicated infections), August 2013 (peripheral neuropathy), and July 2008 (tendinitis and tendon rupture).

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving fluoroquinolones or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

More information about the link between fluoroquinolones and aortic aneurysm and dissection can be found in these studies or articles:

  1. JAMA Internal Medicine, “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone
  2. BMJ Open, “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study
  3. BMJ, “Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study
  4. Baylor College of Medicine, “Ciprofloxacin increases risk of tears, rupture in mouse aortas

Additionally, here are some news articles about the FDA acknowledgement of the link between fluoroquinolones and aortic aneurysm and dissection:

  1. CNN, “Certain antibiotics may cause aortic aneurysm, FDA warns
  2. NBC News, “FDA warns some antibiotics can cause fatal heart damage: Drugs commonly used to treat upper respiratory infection, urinary tract infections should not be prescribed to patients already at risk
  3. Medscape, “More Fluoroquinolone Safety Concerns
  4. WRIC ABC 8 Richmond, “Commonly prescribed antibiotics can cause potentially deadly ruptures, FDA warns

Are Fluoroquinolones Causing Connective Tissue Disorders that are Leading to ME/CFS?

The symptoms of fluoroquinolone toxicity often mimic those of ME/CFS (Myalgic encephalomyelitis/chronic fatigue syndrome). Many people suffering from fluoroquinolone toxicity experience debilitating fatigue, and some are bed-bound and permanently disabled from this symptom, along with all the others that come along with fluoroquinolone toxicity. Both fluoroquinolone toxicity and ME/CFS are multi-symptom, chronic syndromes that are poorly understood and often disregarded by those in the medical community. Research into the mechanisms behind both fluoroquinolone toxicity and ME/CFS show that mitochondria (the energy centers of our cells) are likely related to both diseases, and so is autonomic nervous system dysfunction, mast cell activation, metabolomics, epigenetics, immune system dysfunction, hormonal imbalances, and other areas of human biology. Both fluoroquinolone toxicity and ME/CFS also have significant overlap with other diseases such as Ehlers-Danlos syndromes (EDS), Postural orthostatic tachycardia syndrome (POTS), and fibromyalgia.

The similarities between fluoroquinolone toxicity and ME/CFS may mean that they have a similar root mechanism…. or they may not. The root cause of fluoroquinolone toxicity is, of course, fluoroquinolones. (The mechanism behind fluoroquinolone toxicity is much more complex and the answer to the question of HOW fluoroquinolones hurt people is still being uncovered.) Most people who have ME/CFS don’t report that their symptoms started with fluoroquinolone exposure (though there is almost certainly some overlap, and there are likely some people who have been diagnosed with ME/CFS whose disease started with a fluoroquinolone prescription). There seem to be a variety of triggers that set off ME/CFS in previously healthy individuals, including, but not limited to, mold exposure and sensitivity, and exposure to a viral infection that the body never fully recovers from.

While it is possible that there are many cases of ME/CFS that were brought on by fluoroquinolones, and thus are “actually” fluoroquinolone toxicity (labels, shmables), it is also possible that both diseases/syndromes have a similar underlying mechanism despite different causes, and it is also possible that though the symptoms and features of both diseases are similar, they are actually different on a mechanistic and/or cellular level.

Though the possibilities for differences between fluoroquinolone toxicity and ME/CFS are potentially significant, the similarities are obvious, and it is likely that research that helps ME/CFS sufferers will help fluoroquinolone toxicity sufferers.

There is a theory about the mechanism behind ME/CFS that has recently come to my attention that could, potentially, tie it more directly to fluoroquinolone toxicity. The theory, in a nutshell, is this:

Some people with ME/CFS have an underlying predisposition for EDS, and thus collagen synthesis is disordered and connective tissues are weakened. The ligaments of the craniocervical junction (where your skull meets your first vertebra) become weak and this leads to craniocervical instability (CCI) and atlantoaxial instability (AAI) (together, CCI/AAI). When people suffer from CCI/AAI their neck ligaments don’t sufficiently hold up their head and their brain stems are compressed into their spines. This causes many symptoms of ME/CFS. (I’m not sure exactly how – ask someone who has done far more research into ME/CFS and/or CCI/AAI than me.)

You can read about how CCI/AAI relates to ME/CFS in these two links:

  1. MEchanical Basis
  2. A new diagnosis to add to the list: I have craniocervical and atlantoaxial instability

How does this relate to fluoroquinlones?

It is well known that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others) damage connective tissues–including musculoskeletal connective tissues like tendons, cartilage, bone, and muscle, as well as other connective tissues such as ocular tissue (including the retina)eardrums, and cardiac/heart tissue. Multiple studies have found that fluoroquinolones are toxic and damaging to connective tissues. Given the wide differences in tissues that fluoroquinolones have been shown to deleteriously affect–from cartilage to cardiac tissue–it is reasonable to assert that they damage all connective tissues throughout the body. (Read any of the articles in the citations listed below for information about how fluoroquinolones damage connective tissues.)

Given that fluoroquinolones damage connective tissues (probably all connective tissues – see links below), it is possible that they weaken the tendons of the neck and thus lead to CCI/AAI. CCI/AAI then leads to multi-symptom chronic illness including all the symptoms of ME/CFS (which are too numerous to count).

This weakening of tendons and subsequent CCI/AAI likely occurs more often in people with underlying connective tissue disorders like EDS. I suspect (though I have no proof of this) that there are many kinds of EDS that have not yet been identified, and that more people have the genes for a variation of EDS than those who can currently be diagnosed with the disease. It’s also possible that a genetic predisposition toward EDS is not necessary for fluoroquinolones to cause extensive connective tissue damage, and that they do so in everyone who is exposed to them (at varying levels, of course). Fluoroquinolones have been shown to damage dog and rat connective tissues, especially tendons, and human connective tissues exposed to fluoroquinolones have also shown extensive damage both in-vitro and through analysis of people exposed to fluoroquinolones. I have a hard time believing that all the rats, puppies, and people whose tissues were sampled all had underlying EDS prior to their tissues being destroyed by fluoroquinolones. However, it’s possible that underlying genetic predispositions, including those for EDS, determine how severely people are affected by fluoroquinolones. More research is, of course, needed.

Are fluoroquinolones causing CCI/AAI? And is CCI/AAI leading to ME/CFS? Given the large number of studies showing that fluoroquinolones destroy connective tissues and interfere with collagen synthesis, it’s quite plausible (even likely) that they cause CCI/AAI. How, and if, CCI/AAI is connected with ME/CFS is another question. But given the experiences of the authors of MEchanical Basis and A new diagnosis to add to the list: I have craniocervical and atlantoaxial instability, it’s a possibility that is certainly worth exploring.

 

Sources for the assertion that fluoroquinolones cause connective tissue destruction and disordered collagen synthesis:

Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population. Hall, Mederic M. et al. PM&R , Volume 3 , Issue 2 , 132 – 142

Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral Fluoroquinolones and the Risk of Retinal Detachment. JAMA. 2012;307(13):1414-1419. doi:10.1001/jama.2012.383

Tsai WC, Hsu CC, Chen CP, et al. Ciprofloxacin up-regulates tendon cells to express matrix metalloproteinase-2 with degradation of type I collagen. J Orthop Res. 2011;29(1):67-73

Lee C, Lee MG, Chen Y, Lee S, Chen Y, Chen S, Chang S. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA Intern Med. 2015;175(11):1839-1847. doi:10.1001/jamainternmed.2015.5389

Kaleagasioglu F, Olcay E. Fluoroquinolone-induced tendinopathy: etiology and preventive measures. Tohoku J Exp Med. 2012;226(4):251-258.

Adel Alrwisan, Patrick J. Antonelli, Almut G. Winterstein; Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study. Clin Infect Dis 2017; 64 (8): 1052-1058. doi: 10.1093/cid/cix032

EMA Committee Recommends Restricting Fluoroquinolones

The European Medicines Agency (EMA) put out the press release entitled “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” on November 16, 2018. It goes over the recommendations of the EMA’s Committee for Medicinal Products for Human Use (CHMP), and expands on the earlier recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC). Following are some highlights from “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics.”

“The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.”

This is a strong statement from the EMA. It is recommended that the fluoroquinolones that remain on the market in Europe (including, but not limited to, ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and norfloxacin) will be restricted, and patients and healthcare providers alike will be given information about the disabling effects of these drugs. That’s a HUGE step in the right direction!

“Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.”

This list is great, and if it, combined with the US FDA’s list of ailments for which fluoroquinolones should not be used, is followed, fluoroquinolone prescriptions will be cut significantly.

I am particularly pleased to see that the EMA is recommending against use of fluoroquinolones for treatment of chronic prostatitis. Too many men have been severely injured by fluoroquinolones given to them for treatment of non-bacterial prostatitis, a condition for which fluoroquinolones are no better than a placebo.

It is also wonderful to see that the EMA is recommending against the prescription fo fluoroquinolones for prevention of traveller’s diarrhea/diarrhoea. No one should ever be prescribed a drug as dangerous and consequential as fluoroquinolones “just in case” they get traveller’s diarrhea.

“Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.”

Yes – exactly – fluoroquinolones should be avoided in people who have previously experienced side-effects from fluoroquinolones. More information about that can be found in “The Next Time Will be Worse: Cross-Reactivity of Fluoroquinolones.”

I would say that fluoroquinolones should never be used on patients who are elderly, who have kidney disease, or who have had an organ transplant, but use “with special caution” is a step in the right direction.

“The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU countries. National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics.”

Stay tuned. I’ll highlight the final decision made by the EMA once it is published.

The EMA press release, “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” also contains the following guidance for patients:

Information for patients

  • Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.
  • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
  • Tendon swelling and injury may occur within 2 days of starting treatment with a fluoroquinolone but may even occur several months after stopping treatment.
  • Stop taking a fluoroquinolone medicine and contact your doctor at once in the following cases:
    • at the first sign of tendon injury, such as tendon pain or swelling – rest the painful area;
    • if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms;
    • if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing. You and your doctor will decide if you can continue treatment or if you need to take another type of antibiotic.
  • You may be more prone to joint pain or swelling or tendon damage if you are aged over 60 years, your kidneys do not work well or you have received organ transplantation.
  • Speak with your doctor if you are taking a corticosteroid (medicines such as hydrocortisone and prednisolone) or need to have treatment with a corticosteroid. You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time.
  • You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.
  • If you have any questions or concerns about your medicines, speak to your doctor or pharmacist.

And it also contains the following guidance for prescribers:

Information for healthcare professionals

  • Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses.
  • The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.
  • Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment.
  • Patients who are older, have renal impairment or have had solid organ transplantation and those being treated with a corticosteroid are at higher risk of tendon damage. Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
  • Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation and patients should be advised to stop treatment with a fluoroquinolone and speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness so as to prevent development of potentially irreversible condition.
  • Fluoroquinolones should generally not be used in patients who have had serious adverse reactionsassociated with the use of quinolone or fluoroquinolone medicines.
  • Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine. This is because the indications for these medicines have been restricted.
  • The benefits and risks of fluoroquinolones will be monitored continuously and a drug utilisation study will evaluate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by investigating changes in prescribing behaviour.

Healthcare providers should also be informed that there is no known cure or remedy for fluoroquinolone toxicity, and that the effects of these drugs can be permanent.

This information should also be given to patients.

Overall, I’m pleased with the CHMP recommendations, and I’m hopeful that the final, binding ruling from the EMA is as strongly worded, and even more comprehensive.

*****

Fluoroquinolone Toxicity Awareness Friday

Today, Friday November 9th 2018, is the first Fluoroquinolone Toxicity Awareness Friday. Please join me, and other fluoroquinolone toxicity awareness advocates, in spreading the news far and wide about the dangers of fluoroquinolones, and the devastation and destruction that fluoroquinolones have brought to too many lives.

Mark A Girard, fellow fluoroquinolone victim and advocate, posted this on his Facebook page(s):

Please join in as we do all sorts of things to raise awareness about FQs. We chose the final Friday before Antibiotic Awareness Week (Nov 12-19) so that people remember what they saw or read or heard when they see something else about antibiotics in the media. This is a genuine grass roots effort to get the help we need and deserve and to prevent others from suffering similar damage. We are hoping people will reach out to the media, to government agencies, to their friends and families and so on. We will be discussing all sorts of things people can do and of course everyone is encouraged to contribute in their own unique ways. Use your skills and your imagination and help us to build an annual tradition that makes a difference in more people’s lives each November. If you want, you can continue with awareness efforts all week long with me, but we are hoping to get something going where we all do something on Friday, whether it is to tell your story on your timeline or to share a favourite article, newscast or meme. It’s a Horton Hears a Who situation so please take some time and add your voice to the shouting and maybe they will finally hear us loud and clear. Thanks!

Please feel free to copy and paste it into your status, or, if you’re Facebook friends with Mark, please share it. Or you can let your friends and family know about Fluoroquinolone Toxicity Awareness Friday by sharing this post.

Some suggested things to share are:

  1. Amy Moser’s VIRAL post, “This Antibiotic Will Ruin You
  2. Popular and influential news story – CBS Los Angeles, “Southland Firefighter Says Popular Antibiotic Poisoned His Body, His Life
  3. Popular and influential news story – WSB TV 2 Atlanta, “Local woman says popular antibiotic killed her husband
  4. In-depth investigative report – PBS Frontline Investigation, “Certain Antibiotics Spur Widening Reports of Severe Side Effects
  5. News story out of Europe – Daily Mail, “Antibiotics got rid of her chest infection – but Jane says they destroyed her health
  6. Story in the well-respected journal, Nature, “When antibiotics turn toxic
  7. New York Times column, “Popular Antibiotics May Carry Serious Side Effects
  8. Popular post on Floxie Hope, “FDA Announces that Permanent Peripheral Neuropathy is to be Added to Warning Labels for Fluoroquinolone Antibiotics
  9. Popular post on Floxie Hope, “New Study Finds that Ciprofloxacin Depletes Mitochondrial DNA
  10. Popular post on Floxie Hope, “Letter from Bayer to Doctors Regarding Cipro and Avelox

There are links to hundreds of other articles and news stories on the “Links & Resources” page of this site.

Please share these, and anything else that brings attention to the devastating effects of fluoroquinolones, on social media, with your friends and family, with influential news organizations, with politicians, etc. Get the news out far and wide – THANK YOU!

*****

Letter to the EMA

Following is a letter that I (Lisa Bloomquist) wrote to the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP will be reviewing fluoroquinolones starting on November 12, 2018, and they will make recommendations for use, marketing, and restriction of fluoroquinolones. Please consider sending a similar letter to them before 11/12/18. Contact information for all CHMP members can be found HERE

Dear CHMP Reviewers,

Thank you for thoughtfully reviewing fluoroquinolones and for considering the following information.

Fluoroquinolone antibiotics are causally associated with tendon ruptures, serious psychiatric disturbances, blood-sugar irregularities, peripheral neuropathy, autonomic nervous system dysfunction, disabling multi-symptom chronic illness, and many other symptoms that are both listed on the US FDA warning labels and noted in the many patient reports that can be found in published case-reports, testimonials provided by victims, and anecdotes. The devastating and disabling effects of fluoroquinolone antibiotics were brought to the attention of the EMA during the PRAC hearing on the 13th of June 2018.  It is my hope that you have listened to the patient testimonials presented to the PRAC, and that you are familiar with the severity of fluoroquinolone toxicity symptoms. In this letter, I will present some mechanisms through which fluoroquinolones lead to the symptoms noted above. I hope that you take these mechanisms into consideration when reviewing fluoroquinolones and making a judgement about their marketing and availability.

Fluoroquinolone Damage Mechanism 1 – Topoisomerase Interruption

The US FDA warning label for ciprofloxacin notes that, “The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.”

Fluoroquinolones are topoisomerase interrupters, and thus, as intended, they disrupt the process of bacterial DNA and RNA replication.

Though it is claimed that fluoroquinolones disrupt bacterial DNA not human nuclear DNA, this argument does not take into consideration the importance of bacterial DNA in human health, the fact that mitochondrial DNA is similar in structure to bacterial DNA, or the potential for promiscuous binding of fluoroquinolones to human nuclear DNA.

Fluoroquinolone Damage Mechanism 2 – Depletion of Mitochondrial DNA

Several studies have noted that fluoroquinolone antibiotics deplete mitochondrial DNA. In “Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2” (1) it is noted that:

“Loss of Top2β or its inhibition by ciprofloxacin results in accumulation of positively supercoiled mtDNA, followed by cessation of mitochondrial transcription and replication initiation, causing depletion of mtDNA copy number. These mitochondrial effects block both cell proliferation and differentiation, possibly explaining some of the side effects associated with fluoroquinolone antibiotics.”

Similar findings were published in 1996 in the article, “Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells” (2).

Fluoroquinolone Damage Mechanism 3 – Increase in ROS and depletion of antioxidants

The study, “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients” (3) notes that fluoroquinolones decrease superoxide dismutates (SODs) and glutathione, and increase lipid peroxide levels.

Fluoroquinolone Damage Mechanism 4 – Neurotransmitter disruption and GABA inhibition

Fluoroquinolones are known to inhibit the activity of the neurotransmitter GABA, and to disrupt other neurotransmitter activities. The article, “Ciprofloxacin-induced neurotoxicity: evaluation of possible underlying mechanisms” (4) notes the following in its abstract:

Ciprofloxacin (CPX) is a fluoroquinolone antibiotic used for treating respiratory, urinary tract, gastrointestinal and abdominal infections. There are only a limited number of studies related to neurological adverse effects of this drug in therapeutic doses. Therefore, in the present study, we aimed to investigate the influence of CPX, when administered at pharmacological doses, on behavioral parameters of rats and the probable underlying mechanisms. CPX was administered in single oral daily doses of 20 and 50 mg/kg for 14 days in rats. CPX-induced depression and anxiety were evaluated by modified forced swimming test and elevated plus maze test, respectively. Also, spontaneous locomotor activity and motor coordination were assessed by activity cage and Rota-rod apparatus. Effects of CPX administration on brain serotonin, dopamine, γ-amino-butyric acid (GABA), glutamate, adrenaline and noradrenaline levels were determined by high performance liquid chromatography (HPLC) analysis. Contribution of oxidative stress to the changes induced by CPX administration was evaluated by measuring brain catalase, superoxide dismutase, glutathione (GSH) and malondialdehyde (MDA) levels. Our results indicated that depression-like and anxiety-like behaviors were observed only in the 50 mg/kg CPX-administered group with simultaneous decreases in the brain serotonin and GABA levels. In addition, in the brain homogenates of CPX-administered groups, increased MDA as well as decreased GSH and catalase activity with respect to their controls, indicated enhanced oxidative stress and weakened antioxidant defense system. In conclusion, repeated pharmacological doses of CPX were found to induce neurological toxicity. Also, altered brain neurotransmitter levels and increased oxidative stress observed in our study were thought to be the possible underlying mechanisms of ciprofloxacin-induced neurotoxicity.

Several studies, including “Benzodiazepine tolerance, dependency, and withdrawal syndromes and interactions with fluoroquinolone antimicrobials” (5) have noted that fluoroquinolone toxicity symptoms mimic those of benzodiazepine withdrawal.

Fluoroquinolone Damage Mechanism 5 – Depletion of Magnesium and Iron

The article, “Integrins on joint cartilage chondrocytes and alterations by ofloxacin or magnesium deficiency in immature rats” (6) notes that, “Recently, we showed that magnesium deficiency induces lesions in knee joint cartilage from 5-week-old rats that are very similar to ofloxacin-induced cartilage defects. We concluded that quinolone-induced arthropathy is probably due to chelation of magnesium and thus a deficit in functionally available magnesium in joint cartilage (Stahlmann et al. 1995).”

The article, “Nonantibiotic Effects of Fluoroquinolones in Mammalian Cells” (7) notes that, “Here, we show that the FQ drugs norfloxacin, ciprofloxacin, and enrofloxacin are powerful iron chelators comparable with deferoxamine, a clinically useful iron-chelating agent.”

Both cellular magnesium and iron are necessary for multiple enzymatic reactions, and they are necessary for health. Fluoroquinolones deplete both magnesium and iron, and may deplete other crucial minerals too.

Fluoroquinolone Damage Mechanism 6 – Microbiome Destruction

The importance of the gut microbiome has recently been uncovered. As a powerful class of antibiotics, fluoroquinolones disrupt the balance of gut microbiota in many ways. The consequences of gut microbiome disruption are now being uncovered. A disrupted gut microbiome has been linked to various diseases from Parkinson’s to Autism.

Fluoroquinolone Damage Mechanism 7 – Fluorine

Fluoroquinolones are fluorinated drugs, and it is known that fluorine displaces iodine, an element that is essential in the synthesis of thyroid hormones. Excess fluorine is linked to skeletal fluorosis (8), lowered IQ (9), and other health maladies. A significant amount of information about the harm that fluoride does can be found on the Fluoride Action Network web site, www.fluoridealert.org.

Additionally, it is recommended that the question of whether fluoroquinolones are metabolized into fluoroacetate be explored further.

Fluoroquinolone Damage Mechanism 8 – Thyroid Hormone Disruption

A significant amount of information about the connections between fluoroquinolones and thyroid hormone disruption can be found on the web site www.fluoroquinolonethyroid.com, and a summary of the connections can be found onhttp://www.hormonesmatter.com/fluoroquinolone-antibiotics-thyroid-problems-connection/.

Thyroid hormone disruption can lead to multi-symptom chronic illness, and most people suffering from fluoroquinolone toxicity would classify their illness as both multi-symptom and chronic. The connections between fluoroquinolone antibiotics and thyroid hormone disruption should be explored further.

Fluoroquinolone Damage Mechanism 9 – Epigenetic Changes

The article, “Epigenetic side-effects of common pharmaceuticals: A potential new field in medicine and pharmacology” (10) notes that:

“Interestingly, extensive changes in gene expression were found in articular cartilage of rats receiving the quinolone antibacterial agent ofloxacin, suggesting a potential epigenetic mechanism for the arthropathy caused by these agents. It has also been documented that the incidence of hepatic and dysrhythmic cardiovascular events following use of fluoroquinolones is increased compared to controls, suggesting the possibility of persistent gene expression changes in the liver and heart.”

Additionally, the published letter, “Hereditary Neuropathy Unmasked by Levofloxacin” (11) notes that a course of levofloxacin triggered Charcot-Marie-Tooth disease in a patient. Charcot-Marie-Tooth disease is thought to be a purely genetic disease, but the possibility exists that fluoroquinolone antibiotics are unmasking the disease.

Fluoroquinolone Damage Mechanism 10 – Increased MMP Expression

The article, “Ciprofloxacin enhances the stimulation of matrix metalloproteinase 3 expression by interleukin‐1β in human tendon‐derived cells” (12) notes that, “Ciprofloxacin enhances the stimulation of matrix metalloproteinase 3 expression by interleukin‐1β in human tendon‐derived cells.” This increase in MMP expression may have deleterious effects on all collagen and connective tissues.

Other potential damage mechanisms for fluoroquinolones include triggering mast cell activation, post-hepatic syndrome and liver damage, oxalate overload, extreme sensitivity to quinolones in the environment, calcium and/or potassium channel shifts, and many other possibilities. (http://fluoroquinolonethyroid.com/book_page/additional-mechanisms-to-consider/)

Exactly why some people experience devastating adverse reactions to fluoroquinolones is unknown. However, it is known and well-documented that fluoroquinolones cause a myriad of serious and severe adverse effects. I ask you to please thoughtfully consider each of the above mechanisms for fluoroquinolone damage when evaluating fluoroquinolones.

Thank you for your thought and consideration.

Sincerely,

Lisa Bloomquist

www.floxiehope.com

Durango, Colorado

USA

 

References:

  1. Anu Hangas, Koit Aasumets, Nina J Kekäläinen, Mika Paloheinä, Jaakko L Pohjoismäki, Joachim M Gerhold, Steffi Goffart; Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2, Nucleic Acids Research, Volume 46, Issue 18, 12 October 2018, Pages 9625–9636, https://doi.org/10.1093/nar/gky793
  2. Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells. J W Lawrence, D C Claire, V Weissig and T C Rowe. Molecular Pharmacology November 1, 1996, 50 (5) 1178-1188.
  3. Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients. V Talla and PR Veerareddy. J Young Pharm. 2011 Oct-Dec; 3(4): 304–309. doi:  [10.4103/0975-1483.90242: 10.4103/0975-1483.90242]
  4. Sinem Ilgin, Ozgur Devrim Can, Ozlem Atli, Umut Irfan Ucel, Erol Sener & Ilkay Guven (2015) Ciprofloxacin-induced neurotoxicity: evaluation of possible underlying mechanisms, Toxicology Mechanisms and Methods, 25:5, 374-381, DOI: 10.3109/15376516.2015.1026008
  5. Benzodiazepine tolerance, dependency, and withdrawal syndromes and interactions with fluoroquinolone antimicrobials. Br J Gen Pract. 2008;58(550):365-6.
  6. Integrins on joint cartilage chondrocytes and alterations by ofloxacin or magnesium deficiency in immature rats. Förster, C., Kociok, K., Shakibaei, M. et al. Arch Toxicol (1996) 70: 261. https://doi.org/10.1007/s002040050272
  7. Badal S, Her YF, Maher LJ. Nonantibiotic Effects of Fluoroquinolones in Mammalian Cells. J Biol Chem. 2015;290(36):22287-97.
  8. Skeletal fluorosis in relation to drinking water in rural areas of West Azerbaijan, Iran Ali Akbar Mohammadi, Mahmood Yousefi, Mehdi Yaseri, Mohsen Jalilzadeh & Amir Hossein Mahvi Scientific Reports volume 7, Article number: 17300 (2017)
  9. Prenatal Fluoride Exposure and Cognitive Outcomes in Children at 4 and 6–12 Years of Age in Mexico. Morteza Bashash et al. Published:19 September 2017CID: 097017https://doi.org/10.1289/EHP655
  10. Epigenetic side-effects of common pharmaceuticals: A potential new field in medicine and pharmacology. Antonei B. Csoka and Moshe Szyf. Medical Hypotheses Volume 73, Issue 5, November 2009, Pages 770-780.https://doi.org/10.1016/j.mehy.2008.10.039
  11. Panas, M., Karadima, G., Kalfakis, N., & Vassilopoulos, D. (2011). Hereditary Neuropathy Unmasked by Levofloxacin. Annals of Pharmacotherapy, 45(10), 1312–1313. https://doi.org/10.1345/aph.1P786
  12. Ciprofloxacin enhances the stimulation of matrix metalloproteinase 3 expression by interleukin‐1β in human tendon‐derived cells. Anthony N. Corps et al. Arthritis and Rheumatology. Volume46, Issue11. November 2002 Pages 3034-3040. https://doi.org/10.1002/art.10617

 

EMA Decision on Fluoroquinolones – Next Steps

The EMA (European Medicines Agency) review of fluoroquinolones is ongoing, and your input is requested/needed.

On June 13, 2018, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) heard testimony from Europeans who suffered from fluoroquinolone toxicity, and on May 10, 2018, the PRAC issued their recommendations. (You can read and view the patient/victim testimonials HERE, HERE, and HERE, and you can read the PRAC’s recommendations HERE.) The next step is for the Committee for Medicinal Products for Human Use (CHMP) to consider the recommendations of the the PRAC on the safety of medicines on the market and recommend changes to the EMA. The CHMP will recommend changes in the marketing of fluoroquinolones, or may even recommend suspension or withdrawal of fluoroquinolones from the market. You can read more about the role of the CHMP HERE.

I would like to encourage everyone who has been hurt by fluoroquinolones to contact the CHMP so that they can take your testimonials and information into consideration when making their decisions and recommendations. Contact information for the CHMP members can be found HERE. I recommend that you send an email with a brief version of your personal story, along with information and references from the articles about fluoroquinolone toxicity that can be found in the “research” section of the Links & Resources page on this site or elsewhere on the internet to both the CHMP Chair (Harald Enzmann) and the Vice-Chair (Bruno Sepodes) I plan to send a letter that contains a combination of the information in the post, “What is Fluoroquinolone Toxicity” and the information that is found in the ebook, Hacking Fluoroquinolones (I’ll post my letter once I write it). You are welcome to use anything I (Lisa Bloomquist) have written on this site, or in my guest-posts on other sites, in your letters to the CHMP.

The CHMP meeting starts on November 12, 2018, and it is recommended that you send your emails to the Chair and Vice-chair of the CHMP as soon as possible.

Miriam Knight, a fluoroquinolone toxicity victim advocate, co-founder of Quinolone Toxicity Support UK, and an administrator for Fluoroquinolone Toxicity Victims in Europe, has written the following letter, and you are welcome to use it as a template. 

Dear Chair, Vice-chair and other members of the Committee for Medicinal Products for Human Use,

We in Europe wish to express our strong concerns regarding the recent recommendations made by the PRAC following their lengthy review into the side effects of Quinolones and Fluoroquinolones. We understand that the recommendations have now been passed to the CHMP for your opinion. We are very disappointed in the findings so far.

Representatives of this group and also individual members from across the EU were invited to speak at PRAC’s Public Hearing in June. From the EMA website we understand that “Contributions at public hearings inform the committee’s decision-making”. Even after taking part in the teleconference last week we are unable to find any evidence in the recommendations that our written and spoken interventions have in any way been used to inform the PRAC’s decision making.

Our main concern is that the evidence which we and others have provided regarding the damage Fluoroquinolones cause to human mitochondrial DNA (MtDNA) has been totally ignored. This evidence has been in the public domain since 1993 (1,2,3), yet is not mentioned in any of the license applications, SmPCs or PILs. Both the summary of the Public Hearing and the recommendations from the review fail to mention it, despite the overwhelming evidence. We despair that the Agency charged with safeguarding Public Health cannot see the huge danger in licensing products that physically damage humans. We hope that the CHMP and the Pharmacogenomic Working Party will at least understand the implications of this mechanism of action and will take the time to study ALL of the available evidence.

The Medical Profession seem to have a problem understanding how and why the Fluoroquinolone class of antibiotics have such wide ranging effects on some patients, indeed most are unable or do not believe patients when they are told of these side effects even with written and recorded evidence (4). It is clearly within the remit of the Pharmacogenomics Working Party to provide advice to the CHMP on general and product-specific matters relating to pharmacogenomics, although perhaps this aspect of the review was beyond the scope of the PRAC.

Not only do Fluoroquinolones have an effect on MtDNA but they also disrupt the metabolic processes of both our mitochondria (e.g. the TCA cycle) and also our cells (5,6). Again, the evidence for this has been glossed over by the PRAC’s recommendations, despite the many testimonies at the Public Hearing attempting to convey the sheer agonising horror inflicted by these drugs.

We understand from the teleconference that the recommendations passed over to the CHMP are more detailed than the brief version that was published prior to the teleconference. We sincerely hope this is so as all we have seen so far is a tenuous nod towards implementing changes with a view to protecting the public. The biggest risk to human health from the Fluoroquinolones is the damage and destruction caused to every cell (6) – which can potentially lead to multisystem problems including organ failure and cancers (4), and which surely outweigh the benefits. The mitochondrial damage also has implications on second generations – something which has yet to be studied. We notice that the PRAC dropped their original proposal to encourage further studies and research to be undertaken with no explanation. We find this decision, along with all of PRAC’s expressed concerns, to be disingenuous, at the least, at most we find it dangerous to future victims as well as present victims.

We cannot urge strongly enough that you fully and properly review all the evidence showing the catastrophic effect Fluoroquinolones can have both physically and mentally (4). A full understanding of why some people are affected immediately while others can tolerate several courses needs to be taught throughout the medical profession. It is simply not good enough to say these effects are “very rare” when it is well known that many people, after experiencing nothing from a first course go on to be affected by a second or third course. Others seem to tolerate repeated courses before just one more tablet sets off a serious reaction. The variety of personal thresholds is believed to depend on the individual’s mitochondrial condition, including either congenital deficiencies or acquired insults.The reality is that if someone takes enough Fluoroquinolones, they will eventually be affected: this cannot be defined as “very rare”. The true figure is unknown and until extensive research is undertaken it will remain unknown.

It is also not good enough to say these effects are “very rare” when it is well known that neither doctors nor patients associate an ADR that occurs weeks or months after cessation of the Fluoroquinolone with that particular drug – yet this is precisely what happens. There are possibly thousands of people who have been affected yet never know; their symptoms often labelled as Fibromyalgia or CFS/ME (which, ironically, have no known cause) or even MS.  Many times we have heard of e.g. eye specialists saying they have prescribed Fluoroquinolones hundreds of times yet no one has reported any problems: why would a patient with sudden muscle or tendon problems go back to their eye specialist? More patients have been seriously affected by Fluoroquinolones than anyone can imagine.

All Medical Professionals, member state Health Agencies and ALL committees working within the EMA have to fully understand the human catastrophe caused by this unique class of drugs (not exactly antibiotics as they have also been used as chemotherapy agents). Until the naïve ‘one size fits all’ approach to medicine is overturned – and this is obviously where the Pharmacogenomics Working Party is essential – innocent patients will continue to be harmed by the innocent doctors who are trying to do no harm.

References*:

1). Acridones and quinolones as inhibitors of ubiquinone functions in the mitochondrial respiratory chain. July 1993 Walter Oettmeier et al
https://pdfs.semanticscholar. org/a9fd/ 33039c3d987093746db40fbd8d7782 f3b078.pdf
2). Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells. Nov 1996 Lawrence JW et al.
https://www.ncbi.nlm.nih.gov/ pubmed/8913349
3). Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2 August 2018 Hangas et al
https://academic.oup.com/nar/ article/46/18/9625/5088042? fbclid= IwAR0Xu4wIXprB3wF6nBP2EZxWinNm mVvUvjIQ8GPHPaLS81KsxE_ ucJZ99K8
4). Fluoroquinolone-induced serious, persistent, multisymptom adverse effects.
Oct 2015. Golomb B. et al
http://casereports.bmj.com/ content/2015/bcr-2015-209821. full
“…with progression that continued following discontinuation evolving to a severe, disabling multisymptom profile variably involving tendinopathy,muscle weakness, peripheral neuropathy, autonomic dysfunction, sleep disorder, cognitive dysfunction and psychiatric disturbance..”
5). Exploiting bacterial DNA gyrase as a drug target: current state and perspectives
Nov 2011 Frédéric Collin et al.
https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3189412/
6).Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications
Nov 2017. Michalak K. et al .
https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC5632915/

* These few references have been chosen as the most relevant to this letter.  The PRAC tell us they studied over 400 papers before reaching their decision but have not yet told us which 400.  As all scientists know, it is possible to reach any conclusion you like depending on which papers you quote. There are many more than 400 papers available which show the harm that can be caused by Fluoroquinolones.  Perhaps the best way to judge the danger is to work with the actual sufferers (we are either sufferers or carers ourselves) – as Dr Golomb (4) has done.

Thank you, Miriam, for all your advocacy work with the EMA (including the PRAC and CHMP)! And thank you to all who reach out to the CHMP – your advocacy work is appreciated too!

The PRAC recommendations were disappointing for many fluoroquinolone victims and advocates. Hopefully the CHMP recommendations will be stronger and more protective of patients.

Remote Work After Fluoroquinolone Toxicity

This is a guest post written by Michelle P. You can learn more about Michelle’s experience with fluoroquinolone toxicity on her episode of The Floxie Hope Podcast – https://floxiehope.com/2017/07/17/floxie-hope-podcast-episode-22-michelle/. You can also read about her fluoroquinolone toxicity journey on her web site, https://barefootaya.com/. 

 

When I was floxed in July 2016, I was working a very high stress, physical job in Los Angeles. I worked on film sets for over 12 hours a day, usually 6 days a week. It was an excruciating position as a healthy person, but as a floxed person, it was much worse.

For the first month I was floxed, I only had fatigue for the month of July (I had taken Cipro in late June), so I didn’t know anything was wrong and I had continued working, trying to get extra sleep by going to bed earlier and earlier. I usually went to work around 6AM or 7AM and came home around 7PM-9PM. By earlier and earlier, I mean that at one point I went to bed at 8PM to wake up for a 7AM call and I still felt exhausted. “This job is killing me!” I thought… but it was the Cipro.

Anyway, about a month into it, my arm went numb, then the rest of my body, yada yada. The fatigue was so bad that I could barely stand at work and I started becoming super anxious, partially from the raging neurotoxicity I didn’t yet know about and partially from a very understandable reaction to feeling your entire body slowly become numb. I wasn’t sure what was happening to me, so for the first few days, I continued to work and refused to drive. What if I would become paralyzed, like with Guillain Barré, or something? I didn’t know.

Fast forward to being bed bound at my parents’ house with tendon damage, panic attacks, and the ability to stick a needle in my arm only to feel nothing (this helped for the hundreds of blood tests I received – no exaggeration.) My parents lived in rural Upstate New York, a much different place from the Californian city I called home.

I was nervous, not just for my health, but for my finances. I had done enough research on Fluoroquinolone Toxicity at this point that I was confident in my ability to heal… or at least that I was trying my best. We would see about the outcome. As for my finances, I had just spent $1000 to ship my car across the country (I still couldn’t drive) along with flight tickets and thousands of dollars in medical bills, waiting for a collection agency to pick them up. Oh, and I had 5 figures worth of student loans due in a week with my bank account in the red. Film set work, contrary to popular belief, isn’t so glamorous and it doesn’t pay well.

The YouTube videos I watched and the stories I read from other floxies were from people who were married to a partner with health insurance, from people who were already retired, from those who had savings accounts with more than a couple thousand dollars, or from people who were ‘so grateful’ that they had the ability to work from home.

I couldn’t work from home at all for my job at the time. My job was all in person: moving set pieces, walking cast to the stage, coordinating meals for the crew, organizing paperwork, etc., so I lost my job and I was left with nothing income-wise.

After posting on Facebook updating my extended network about my health status, my words reeked of anxiety. I received a private message from an old college friend that went something like this: “Hey, I’m guessing you need a job that you can work from home right now.”

He was reading my mind. “I’m not sure if my current job is hiring, but they will be. I’m quitting next week. I can refer you.”

My friend hooked me up with a job writing video scripts and editing video for newspaper articles. It paid $15/hr, which wasn’t great, but it was something to hold me over. I could make my own hours and I had to work a minimum of 20 hours. It was perfect. I took the job.

Unfortunately for floxies, covering the news isn’t really great for chemically-induced anxiety. I wrote scripts for news articles about deaths, politics, makeup routines (why), and unnecessary celebrities like The Kardashians. It was soul-sucking and once I started healing, I would notice that it induced my anxiety, my hands and feet would go numb again, and I would have panic attacks later that day. Thanks, Cipro! I quit the job.

Months later, I needed a new job and I wanted something that gave me as much freedom as this job had. Another friend of mine who was traveling in South America told me that she was teaching English as a Second Language to Chinese kids online. That seemed interesting, so I asked her for more information and she ended up referring me for the position.

What’s great about this job is that it has even more flexibility since it has no minimum or maximum amount of hours you can work. There are incentives for just about everything and the company cares a lot about their employees. Although you work from home as your own boss with no other coworkers, there are teacher groups within the company website and on social media that can answer your questions, commiserate with you, and give you a community to fall back on.

You don’t make a curriculum, you don’t need to buy anything, and you don’t need to sell anything, either. The only requirements are that you have a working computer with a webcam, a stable internet connection, a Bachelor’s degree, at least a year of teaching experience (could be anything from tutoring to being a ski instructor), and experience working with children. That’s it. How much you want to put into the job is up to you.

I currently work at three different online ESL companies:

VIPKID : Teach kids for around $20/hr on average, Bachelor’s degree and native English speaking required. Growing rapidly, largest online ESL company. Ref code: MICHE0384

gogokid : Teach kids for around $22/hr on average, Bachelor’s degree, online teaching experience, and native English speaking required, must teach at least one class a week. Brand new company. Ref code: YH2HDTPA

Cambly : Speak with advanced English speaking adults for $10/hr. This is mostly conversation practice, no curriculum required. No qualifications. Ref code: mischa5

I am so grateful for these companies for keeping me afloat during hard times and allowing me to work for myself in the best way possible. Now I’m mostly recovered, but I plan on sticking with them for the long haul. I had a flare up a few weeks ago and I didn’t have to call in sick. I didn’t have to lose money. I could just sit in a chair and teach English from my home, even with inflamed, damaged tendons.

I wish I had known about this opportunity when I first got floxed because it is such a low-stress job and it pays decently, unlike some of the other work-from-home options out there.

If you want to learn more, and/or you’re interested in applying, please feel free to email me at barefootaya@gmail.com. I can give you tips on your application and walk you through the process.

 

******

Fluoroquinolone Toxicity Films

I have come to the conclusion that being a film-maker is a risk factor for having an adverse reaction to fluoroquinolones. I have been emailed by no less than a dozen people in the film industry, mainly independent documentarians, who have been floxed and who express desire to make a film about fluoroquinolone toxicity. I haven’t been approached by authors, or people who are on the radio, or any other type of media personnel – only film-makers. Film-makers beware – DO NOT TAKE FLUOROQUINOLONE ANTIBIOTICS.

Of course, I’m joking. It is illogical, and impossible, for film-makers to be at higher risk of fluoroquinolone toxicity than anyone else. Film-makers shouldn’t take fluoroquinolones because no one should take fluoroquinolones, but I see no reason that they would be at higher risk of fluoroquinolone toxicity than anyone else.

Still…. I have gotten several, maybe dozens, of emails from floxed film-makers who have expressed interest in making a film (or documentary, sorry, I don’t know the difference) about fluoroquinolone toxicity. I applaud their initiative and I encourage anyone/everyone who is interested in making a film about fluoroquinolone toxicity to do so.

The more the merrier, and if there were 20 films about fluoroquinolone toxicity, that would be awesome. However, maybe it would be good for the many film-makers who are interested in fluoroquinolone toxicity to join together and combine their talents, efforts, finances, and resources – just a suggestion.

Over the years, I have lost track of most of the emails from floxed film-makers. On the off chance that some of the floxed film-makers follow this blog, and are interested in collaborating, I would like to offer to connect you. Please contact me using the following form if you want me to connect you with others who are interested in creating a film about fluoroquinolone toxicity:

Though many film-makers have noted their interest in creating a film about fluoroquinolone toxicity, I only know of one who is currently in the process of making one. Michelle P is currently working on “Floxed”. Please “like” her page on facebook and support her efforts. There is a “send message” button on the Floxed documentary facebook page, and that’s probably a better way to reach Michelle than the contact form above, but I’m still happy to facilitate connections.  https://www.facebook.com/floxeddoc/

There are a couple of finished films about fluoroquinolone toxicity that I recommend. The first is Certain Adverse Events, by Nancy Edwards. You can purchase Certain Adverse Events on Amazon – https://www.amazon.com/Certain-Adverse-Events-Nancy-Edwards/dp/B0076D0B2G.

One of the 5-star reviewers of Certain Adverse Events states:

“I will never forget the date of 3-1-10. That’s the day I took a week long course of Cipro and went from being a very athletic and healthy 42 year old professional to a disabled cripple in one short week. That’s how devastating the side effects from these drugs are. Two years have passed since then and I am still in chronic pain with major nerve, tendon and cartilage damage throughout my body. This film does a great job of showing how many people are affected by this class of antibiotics and why the US regulatory system has thus far failed to properly regulate these drugs. It interviews victims, doctors, pharmacists and lawyers to help you make an informed decision on your own health. I wish I’d seen this film before it was too late for me.”

Here is an excerpt of the film on youtube too (but please buy it on Amazon – support independent film-makers who are drawing attention to an important issue – thank you):

Another film that features fluoroquinolone toxicity is a fiction (or whatever the equivalent word about films is) film called The East. I wrote about The East in the post, “Fluoroquinolone Toxicity Featured in the Movie ‘The East'”. Here is a trailer:

Please watch, and share, these films, and support the people who are making new films about (or featuring) fluoroquinolone toxicity – thank you!

*****

Survey to Make Medicines Safer

I have followed holistic health coach, advocate, and blogger Alison Vickery for a while. Her site, http://alisonvickery.com.au/ has an immense amount of information about “mysterious” chronic illnesses, and it has particularly interesting and insightful information about histamine intolerance.

Many “floxed” people suffer from histamine intolerance, and/or their symptoms of fluoroquinolone toxicity overlap significantly with the symptoms of histamine intolerance and mast cell activation. Sites such as Alison’s have a wealth of information and resources for those suffering from histamine intolerance and mast cell activation – whether those were brought on by fluoroquinolones or another cause. Many pharmaceuticals, including fluoroquinolones, can trigger histamine intolerance, and the post, “Medicines That Cause Histamine Intolerance” goes over them. I suggest that all of my floxie friends (if you are reading this, I consider you to be a floxie friend) check out alisonvickery.com.au, and that you look into histamine and mast cell activation as they relate to fluoroquinolone toxicity. The post on this site, “Can Fluoroquinolones Activate Mast Cells?” gives some information on the connections between fluoroquinolone toxicity and histamine intolerance and mast cell activation.

Obviously, I think highly of Alison’s work. However, her work on histamine intolerance and mast cell activation are not the main point of this post. The point of this post is to ask for your help with some patient advocacy efforts that Alison is involved in. Alison is currently petitioning/lobbying the Australian government to change how they warn people about dangerous pharmaceuticals. In order to get them to recognize the severity of adverse reactions, and to show that there is support for changing the way that adverse-effects of pharmaceuticals are communicated, she has asked that people who have been hurt by pharmaceuticals complete a survey. This note from Alison explains what she is seeking:

“I am working to lobby the Australian Government on changes and also unite consumer voices to increase the volume. I am wondering if you would share a survey with your followers on boxed warnings. In Australia they are seeking consumer submissions on boxed warnings and also within one month there is going to be a working group on antibiotics. I have been asked to be a consumer representative. At the moment I have virtually no people responding about being floxed. I would also like consumer stories (anonymous to share). They don’t have to be Australian to participate. Is that something you would feel comfortable doing? You’re welcome to ask me any more questions.”

The survey link is – https://www.safemedicines.com.au/boxed_warnings

It is a short survey–it only took me a few minutes to complete. The survey also gives you a chance to tell your story. Please take a few minutes to complete the survey and have your voice be heard. As Alison noted, you don’t need to be Australian to participate.

Alison also stated, “I have come to the conclusion (after getting an inquiry up) that they (the Australian government / regulators) don’t need more information, they are just not scared enough of us yet. The only way is for us to join together. I have no agenda other than to stop people getting hurt. Also if we can get this up in Australia it sets a precedent for others to run with. Any help or support you can give would be awesome.”

And any support that you (floxie friend reading this) can give will be awesome. Thank you in advance those of you who take the time to complete this survey!

The site that the survey is on, https://www.safemedicines.com.au/ Australian’s for Safe Medicines, is also a wonderful site with a great mission. The “Meet Us” page states:

We are a consumer-led association of individuals.

 

We are not for medicines

We are not against them

We are for safe medicines.

 

We seek to empower you, the consumer to;

 

Make informed decisions on medicines

Voice your concerns about medicine safety (including unsafe prescribing practices and your need for new medicines)

Voice your support for any stakeholder striving to make a real difference to medicine safety, and

Disrupt any and all stakeholders that allow unsafe medicine practices to flourish.

 

Do you take

Have you taken or

Are you considering taking medicine?

Will you stand with us for safe medicines?

#mylifematters

 

Indeed, #mylifematters. So does yours. Your voice matters too, and telling your story through surveys such as this one, is immensely helpful. Thank you for your help!

 

 

Floxie Hope Podcast Episode 26 – Tamara

I had the pleasure of interviewing Tamara for Episode 26 of The Floxie Hope Podcast.

Please check out the podcast through this link:

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

You can also read about Tamara’s journey:

https://floxiehope.com/tamaras-story-cipro-toxicity/

Tamara wrote her recovery story back in 2014. She has since had a beautiful, healthy, vivacious little girl, and her life has changed significantly in the last 4 years.

She speaks about her journey through fluoroquinolone toxicity, and how her life has changed in the last 4+ years since she was hurt by Cipro in this episode of The Floxie Hope Podcast.

Thank you for sharing your journey, Tamara!

******

Subscriptions, reviews, and shares of The Floxie Hope Podcast are greatly appreciated! Please let me know if you have questions about how to do any of those things.

******

Fluoroquinolone Warning Labels Updated to Include Low Blood Sugar Levels and Mental Health Side Effects

On 7/10/18 the FDA announced that fluoroquinolone (Ciprofloxacin, Levofloxacin, Moxifloxacin, Ofloxacin, and a few others) warning labels are to be updated to include adverse effects on blood-sugar levels, as well as serious mental health effects:

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

This is a HUGE development! To have the FDA acknowledge that fluoroquinolones cause both hypoglycemia (low blood sugar), and that the effects of hypoglycemia include:

  • confusion
  • pounding heart or very fast pulse
  • dizziness
  • pale skin
  • feeling shaky
  • sweating
  • unusual hunger
  • trembling
  • headaches
  • weakness
  • irritability, and
  • unusual anxiety

is a massive move in the right direction for patients and advocates alike.

Additionally, in the same announcement, the FDA noted that the following mental adverse effects can occur with fluoroquinolone use:

  • disturbances in attention
  • disorientation
  • agitation
  • nervousness
  • memory impairment
  • serious disturbances in mental abilities called delirium.

Fluoroquinolone toxicity victims have long known that fluoroquinolones cause both blood sugar disturbances and serious mental health adverse-effects.

Information about the effects of fluoroquinolones on blood-sugar can be found in these posts/articles:

Information about the mental health adverse-effects of fluoroquinolones can be found in these posts/articles:

Additionally, the book, Bitter Pills: Inside the Hazardous World of Legal Drugs by Stephen Fried goes over his wife Diane’s severe psychiatric adverse reaction to a fluoroquinolone (Floxin/ofloxacin).

WE know about the blood sugar and psychiatric effects of fluoroquinolones. The FDA does too. Now they have acknowledged that they know about these horrible, life-altering, sometimes life-threatening effects of fluoroquinolones.

This acknowledgement from the FDA is a big step in the direction of getting fluoroquinolone toxicity more widely acknowledged. However, whenever there are updates to the warning labels, there are many people who say, “so what? It’s just a warning label that no one pays attention to. When is the FDA going to really DO SOMETHING to fix this problem – like find a cure for fluoroquinolone toxicity and/or remove FQs from the market?” Those people have plenty of good points, and I went into some depth in addressing them in the post, “Change the Warning Labels: Why it Matters.” In that post, I assert that one of the things that changes to warning labels does is open the door for people to sue the drug-makers:

“Warning labels themselves may be useless, but during the time when a warning label has things added to it, they can be a great tool, and a big gun we can use against the pharmaceutical companies. The ONLY times lawyers are willing to take cases to sue the drug companies are when warning labels change. For example, when the fluoroquinolone warning labels were adjusted in August, 2013 to note that permanent peripheral neuropathy is a possible effect of fluoroquinolones, several law firms took cases of those who are suffering from peripheral neuropathy after taking fluoroquinolones. Before the warning label changed, they wouldn’t take the cases, because, appallingly, you can’t sue drug companies for hurting you, you can only sue them for “failure to warn” of the harm they’ll do. It’s a really stupid situation and stupid system. BUT, the time when warning labels change is the brief period of time in which you can sue the drug companies for “failure to warn” and it’s the brief period of time when we have the chance to fight the pharmaceutical companies.”

Everyone who has suffered from hypoglycemia or mental health issues post-fluoroquinolone exposure now has a window open to file a lawsuit against the pharmaceutical companies that made the drugs that hurt them. Here are some law firms that have taken fluoroquinolone-harm cases in the past:

There are others too (feel free to let me know if you know of firms that are taking these cases). I hope that Bayer, Johnson & Johnson/Jansen Pharmaceuticals, and all the generic producers of fluoroquinolones pay for the harm that their products are doing to people, and I encourage all victims to seek justice through the legal system.

I hope that this warning label change will help fluoroquinolone toxicity victims to gain acknowledgement and justice. Everyone who has been hurt by these drugs deserves both.

 

 

EMA Hearing on Fluoroquinolone Toxicity Part 1

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) held a hearing regarding the risks of permanent and disabling effects of fluoroquinolones (i.e. Fluoroquinolone Toxicity) on Wednesday June 13, 8018. More than 100 patient testimonials were submitted to the PRAC, and several dozen people who suffered from fluoroquinolone toxicity testified before the PRAC in-person.

The patients who testified were asked to answer three questions:

  1. What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
  2. What is your view of the risks associated with quinolone and fluoroquinolone use?
  3. In your opinion, what further measures could be taken to optimize the safe use of quinolones and fluoroquinolones?

You can watch the hearing, and listen to the patient testimonials, through this video:

All of the patient testimonials were moving, thought-provoking, and insightful. Thank you to all who testified – many of whom traveled hundreds of miles/kilometers to get to the hearing. It is because of the people who testified (including those who testified in writing) that the PRAC now knows how truly devastating fluoroquinolones are. Hopefully they will be moved to action by the testimonials provided.

A transcript of the hearing will be published, and I will link to it when it is available. In the meantime, I will highlight some of the testimonials given during the hearing. I highly recommend that you watch the video, as the words directly from the victims’ mouths are much more powerful than my synopsis.

Elizabeth Carmouche testified that she was given ciprofloxacin as a prophylactic “in case” she got a urinary tract infection or travelers’ diarrhea while on holiday. She only took two of the prescribed pills, and has been suffering from the devastating effects of those pills for more than two years. She went from being an active to a woman with no pain, to suffering from severe joint, muscle, tendon, and bone pain, as well as peripheral neuropathy. She testified that doctors were unable to help her, and many dismissed the connection between ciprofloxacin and her ill health. She asserted that the following measures need to be taken:

  1. There needs to be official recognition of fluoroquinolone toxicity syndrome, and doctors need to be made fully aware of what the syndrome entails.
  2. Bayer, and the other pharma companies that produce fluoroquinolones, need to identify the precise mechanism of damage done by fluoroquinolones, and those companies need to establish a protocol for healing those who have been hurt by fluoroquinolones.
  3. Patients damaged by fluoroquinolones should be treated and guided by medical professionals.
  4. A red-flag system needs to be put in patient records so that those who have experienced an adverse reaction to a fluoroquinolone are never given fluoroquinolones again.

In closing, Elizabeth notes that fluoroquinolones are linked to mitochondrial damage, and that mitochondrial damage is linked to many diseases including Parkinson’s, Alzheimer’s, and other serious and severe diseases.

The next presenter was a pharmacist from Northern Spain named Manex Bettan Arguinzoniz (Bettan). He was just 37 years old when ciprofoxacin destroyed his body, mind, and health. He went from being athletic and able to play with his children, to being unable to do many of the activities that he loves. Despite being a pharmacist, he was unaware of the debilitating, disabling, and devastating effects of ciprofloxacin. He also found that his doctors and other specialists were unaware of the extent of the damage done by fluoroquinolones. His doctor (who is also his father in law) was only convinced of the link between Bettan’s health problems and ciprofloxacin when another doctor who had studied at the Mayo Clinic noted the reality of the link. Bettan suggests that fluoroquinolones be restricted so that they are only used in life-or-death situations in hospitals. He suggests that a stronger, possibly black-box, warning be added so that patients are aware of the dangers of fluoroquinolones.

One of the EMA PRAC members asked Bettan if he got his information about fluoroquinolone toxicity from patient testimonials or scientific papers. He answered that he read many papers about fluorouinolones. There are hundreds of research papers about fluoroquinolones and the damage they do listed on https://floxiehope.com/fluoroquinolones-links-resources/.

The next presenter was Richard Cooknell. Richard was a firefighter before he was poisoned by quinolones. He is still unable to work, and suffers from many ill effects. He asserts that quinolones are used too widely, and that their use should be restricted to life-or-death situations. Richard points out that fluoroquinolones are often inappropriately prescribed for non-bacterial chronic prostatitis. He also points out that there is no information in the warning label about the effects of fluoroquinolones being permanently disabling, or that adverse reactions can be delayed. Richard was able to gain a diagnosis of fluoroquinolone toxicity by a rheumatologist, and he asked that fluoroquinolone toxicity be more officialy recognized and diagnosed by more doctors.

Richard points out that his prostatitis was non-bacterial, as many cases of prostatitis are, and that he never should have been given fluoroquinolones for a non-bacterial ailment. The post, “Cipro is no better than a PLACEBO at treating chronic prostatitis / chronic pelvic pain syndrome” goes over some information about this.

Richard also points out that NSAIDs and steroids have caused set-backs for him and many other victims of fluoroquinolones toxicity.

The next speaker was Markus Hamedinger. Markus suffers from tendon and joint pain, and has received a confirmed diagnosis of fluoroquinolone toxicity. Fluoroquinolone toxicity has severely affected Markus’s life, and he is unable to do many of the activities that he used to enjoy. His symptoms have not improved in the 2+ years that he has been sick.

Markus asserts that fluoroquinolones are used too often, and that they are inappropriately used when other, safer, antibiotics could be used. He notes the delayed adverse reactions to fluoroquinolones are a factor in keeping the effects of fluoroquinolones under-recognized. He says that doctors need to be made aware of exactly which infections need to be treated by fluoroquinolones, and which infections can be treated with other antibiotics. He also states that fluoroquinolone use should be banned in agriculture, to prevent exposure to fluoroquinolones from occurring through meat consumption.

The PRAC Chairwoman asked a question about repeated exposure making the reaction worse, and Markus noted that his reactions got worse and worse with each fluoquinolone exposure.

The next presenter was Miriam Knight. Miriam also presented on behalf of Raymond Miller and Geoffrey Robinson. Miriam is the co-founder of Quinolone Toxicity Support UK, and is also an administrator for Fluoroquinolone Toxicity Victims in Europe.

Miriam asserts that there is no role of quinolones/fluoroquinolones in the treatment of disease. She notes that mitochondrial DNA wasn’t known, studied, or acknowledged when quinolones were developed, and that they are chemotherapeutic agents.

Miriam points out that despite the official death toll from quinolones being low, there are many people who are hurt by these drugs in fatal ways – including aortic aneurysm.

Miriam notes the damage done by quinolones to mitochondrial DNA, and how mitochondrial DNA damage effects individuals differently depending on a variety of factors.

Miriam asserts, “There will never be a safe use of quinolones. They will always cause damage, observed or not.” And she also states that if removing them from the market is impossible, they should at least be severely restricted.

Miriam also asserts that quinolone toxicity should be a diagnosable illness with a diagnosis code. This is incredibly important in getting it acknowledged and quantifying the damage done by quinolones.

Miriam connects the dots between chronic pain, fibromyalgia, ME/CFS and fluoroquinolone toxicity.

*****

There are several dozen other testimonials. In the interest of the attention-spans of those reading this, I am going to split my notes about the hearing into several posts. This is the first of __ (tbd) posts about the hearing.

THANK YOU to all who testified. The testimony provided is wonderful, thoughtful, passionately delivered, and those who provided it represented themselves and the “floxie” community wonderfully!

End note – To those who testified, if I misspelled your name, please let me know. Also, if anyone would like me to publish their testimony directly, please send it over. Thank you!

 

 

 

My Dear Friend Suzanne

My friend Suzanne was “floxed” as badly as anyone I have ever heard of. She was bed-bound for about a year. She was almost completely paralyzed for a period of time, and it even hurt for her to chew and blink. Every single tendon, ligament, and muscle in her body was damaged and weakened, and she experienced body-wide pain. She suffered from profound fatigue and weakness, and other toxicity symptoms that are far too numerous for me to list. Every cell in her body was adversely affected by the Cipro she took post-appendectomy. Her friends and family feared for her life for a long time, and there were even some times when she didn’t know if she would make it through.

She did make it through though. Suzanne was initially floxed in 2011, and I became familiar with her journey in 2012 when I saw a video of her taking her first steps post-flox (walking out of a pool while doing physical therapy). I had the pleasure of meeting her in-person in 2013 when we both went to Washington D.C. to advocate for fluoroquinolone toxicity awareness, recognition, and change in how fluoroquinolones are prescribed. At that time, Suzanne could walk several steps at a time, though her Achilles tendons were damaged in a way that made it impossible for her to put her heels to the ground, and she always had to have a wheelchair nearby. In-person I got to see what a strong, lovely, kind, thoughtful, interesting, and spirited person Suzanne is. We became friends after that meeting, and corresponded regularly.

In one of her messages to me she said, “While I appreciate your efforts in telling people that recovery is possible, I am not going to recover.  Too much damage has been done.  Some of the damage is irreparable.  I just need to come to terms with it.”

I responded with the post, “Redefining Recovery.” Here is an excerpt from it:

She knows her body, so who am I to argue with her?  She knows that the cartilage in her joints is not going to grow back.  She knows that she will never be able to do the physical things that she used to do with ease before she got floxed, because some of the damage done to her truly is permanent.  She will never run, she will never jump, she will never skydive or play soccer.

She has to come to terms with these things – these limitations that were unfairly and unjustly inflicted upon her.

She IS coming to terms with them.  As difficult as it is, she is finding peace and acceptance of her current condition and realistic future prospects.

Her story is not one of doom and gloom though.  Her story is one of perseverance and strength.  It is an amazing, beautiful recovery story.

My friend has come so, so, incredibly far.  She was completely paralyzed for a while – to the point where she couldn’t even chew and blinking was painful.  Now she can stand and even take a few steps.  She is working hard, with physical and mental therapy, to recover.  And she is recovering.  She is improving every single day.  She is working incredibly hard to do things that most people take for granted – chewing, walking, showering, having lunch with friends, etc.  She is doing those things.  Each one of those things is an accomplishment.  Each one shows recovery.  Each step that she takes is the result of a huge amount of strength, perseverance and bravery.

Suzanne continued to show a tremendous amount of strength and resiliency as her body healed. She had good days and bad, but overall, her momentum was forward, and her capacity increased. She never got to the point that she could return to work, or jog, or do many of the other things that she used to do pre-Cipro, but she did get back to living life. When I saw her again in 2016 she was able to drive, and even walk around without a wheelchair nearby.

Lisa and Suzanne

In 2017 she had a relapse in which the connective tissues in her hands and wrists were attacked, and she was scared that she wouldn’t be able to use her hands any more. Though that relapse was horrible and painful, she survived it, and emerged from it able to use her hands (not like she did before she got hurt by Cipro, but well enough that she was able to live her life).

In 2018 she has suffered a horrible relapse that she is still going through. She is completely bed-bound again, and is suffering from partial paralysis and severe pain. Her neck is swollen and painful, and it hurts for her to both swallow and breathe. She is suffering from CNS symptoms that include hallucinations and dark thoughts. She describes her situation as, “I am currently bed-bound, can’t walk or talk, and am living on baby food and pureed soup. I am suffering from extreme pain in the front of my neck and esophagus and also from central nervous system issues.”

Again, her family, friends, and community are scared for her. I’m scared for her.

I once wrote to her that if she was floxed as badly as I was, she would still be running–but if I was floxed as badly as she was, I’d be dead. I think it’s true too. She’s an amazingly strong person. She is far stronger than I am. She has been through so much pain and suffering, and she got through it, and now it’s being thrown back at her again. It’s awful, and I hate that such an amazing person is being subjected to such horribleness.

Though Suzanne is an incredibly strong person, this relapse is testing her strength and resolve. Her quality of life is horrible right now, and she is grasping for hope that things will get better. One glimmer of hope is that some fellow-floxies have been helped by stem-cell treatments, and she is scheduled to receive a stem-cell treatment in July. She has many obstacles to overcome before she can get the stem-cell treatment. It involves leaving her home and traveling thousands of miles–likely by plane–and that seems difficult-to-impossible right now seeing as she is completely bed-bound. Additionally, money is standing in the way. These treatments are expensive, and she needs help paying for her treatment. She has started a fundraiser to raise funds to cover the treatment and travel expenses. HERE is a link to her fundraiser page (or you can click the pic below to view it):

If you can please help by donating money, your help will be greatly appreciated!

I can’t know whether or not the stem-cell treatment will help Suzanne, but she needs something to work–something to help turn her body around again, and I hope that the stem-cell treatment will be that for her.

Suzanne is a dear friend and a wonderful person. She has helped hundreds, if not thousands, of people in the “floxie” community through providing guidance and advice. She has advocated for victims of fluoroquinolones endlessly in her community of Clearfield, Utah, in Washington, D.C., and also in our online community.

Any help you can give will be appreciated. Thank you for your consideration!

 

Fluoroquinolone Antibiotics Associated with Carpal Tunnel Syndrome

It is well-known and well-documented that fluoroquinolones weaken and destroy musculoskeletal tissues–especially, but not limited to, tendons. 

Additionally, it is known that fluoroquinolones cause neurological problems, and can lead to painful and debilitating peripheral neuropathy. (In 2013, fluoroquinolone warning labels were updated to note that Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin can cause permanent and disabling peripheral neuropathy.)

Given that fluoroquinolones disproportionately affect the tissues in joints, and that they also adversely affect nerves (causing painful neuropathy), it’s not surprising that fluoroquinolone antibiotic use is associated with Carpal Tunnel Syndrome (CTS)–a medical condition that includes “pain, numbness, and tingling, in the thumb, index finger, middle finger, and the thumb side of the ring fingers,” as well as weakness and muscle wasting.

Both CTS and fluoroquinolone-use are common in America, and researchers Jasmine Z. Cheng, Mohit Sodhi, Mahyar Etminan, and Bruce C. Carleton, examined how they are related in “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” published in the journal Clinical Infectious Diseases in August, 2017.

In “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” the researchers found that, “Any use of FQ within the year prior to CTS diagnosis was associated with a 34% and 36% increased risk of CTS in the primary and sensitivity analyses, respectively” and that:

“The results of our study are consistent with an increase in the risk of CTS with FQs. The risk was consistent among all risk periods with a slight increase among past users, which may be due to the longer period elapsed for CTS to manifest itself. FQ-related neurotoxicity can persist cumulatively in relation to exposure levels [8, 9]. The exact mechanism by which this occurs is unknown [9], but proposed models include direct nerve inflammation and ischemia from toxic metabolite and free radical formation [10], and FQ-induced tendonitis/tendinopathy causing mechanical compression upon the adjacent nerves (eg, median nerve) that share the carpal tunnel [11]. Reports of nerve biopsy studies on patients who have experienced FQ adverse events have revealed significantly reduced nerve fiber density consistent with small fiber neuropathy, which may be a potential mechanism of CTS [12]. Although neurotoxicity is the second most commonly reported adverse event, with several studies documenting FQ association with central and peripheral nerve damage [8, 9], this is the first large-scale study exploring the relationship between FQs and CTS.”

CTS is a malady that affects thousands of people and has societal costs in the millions of dollars. In “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” the researchers note that:

“CTS is a disease of significant societal burden with a prevalence of 5% and incidence of up to 2.3 per 1000 person-years [4, 5]. CTS causes loss of function and decreased quality of life for individual patients, and also comprises a large cumulative drain on healthcare and socioeconomic resources from loss of productivity and worker’s compensation claims [6]. One study of 4443 CTS claimants in Washington State estimated a cumulative socioeconomic cost of US$197–$382 million over 6 years for this cohort alone [6].”

Fluoroquinolones are increasing the risk of CTS in millions of people (20+ million prescriptions for fluoroquinolones are written each year). Are doctors or patients aware that they are increasing the patient’s chances of CTS–a painful, debilitating, and costly condition–when fluoroquinolone antibiotics are taken? I doubt it, but they should be.

Please spread the word about how dangerous fluoroquinolones are by sharing posts, news articles, and research articles that connect fluoroquinolones with other illnesses. It wouldn’t occur to most people that a commonly prescribed class of antibiotics could be connected with CTS, psychiatric illness, pain, pseudotumor cerebri, tendon damage and ruptures, or multi-symptom chronic illnesses. But fluoroquinolones ARE connected with those, and other, diseases and syndromes. Articles like “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” help to provide evidence of the extensive damage that fluoroquinolones do, and I am grateful to the researchers who examined the connections. Please spread the word so that doctors and patients alike are informed. Thank you.

 

 

Quinolones in our Environment

Why do some people have relapses of their fluoroquinolone toxicity symptoms? Why is fluoroquinolone toxicity an ongoing illness–a syndrome–and not a one-time event that ends once the drug is metabolized? Why do people seem sensitized after suffering from fluoroquinolone toxicity–with exposures to things that would be benign to healthy people throwing them into a relapse? Why does fluoroquinolone toxicity seem more like an autoimmune or neuroimmune disease than a drug allergy? What does fluoroquinolone toxicity have in common with autoimmune or neuro-immune diseases?

These are all perplexing questions about FQT/FQAD that currently we have no answers for. On the
website http://fluoroquinolonethyroid.com/ many ideas about possible mechanisms regarding some
of these questions are explored (here, here, and here). I found the most recent of these posts,
entitled Nature’s Quinolones: The 4Qs, to offer additional thought-provoking and insightful new
ideas to consider when thinking about questions like these.

This post is a summary of Nature’s Quinolones: The 4Qs, to share the information in it with the
Floxiehope.com audience. There is information in the original article that I won’t be covering in this
post, and I hope this summary inspires you to read more about the details in the original article. I
also hope that any researchers reading this will check out the original article, as it provides a more
comprehensive explanation, along with numerous references, that may be of use in your thought
processes about this topic.

********

There is a bacteria that is ubiquitous in our environment called Pseudomonas aeruginosa, or P. aeruginosaP. aeruginosa is everywhere, including, “soil and water, lakes, streams, rivers, other fresh water, potable water, and sources such as sinks, showers, and hot tubs.” People with healthy immune systems deal with P. aeruginosa without incident. However, P. aeruginosa is a pathogen associated with hospital-acquired infections in immune-compromised individuals, and perhaps it may also be possible that some people have immune systems that over-react to to the bacteria, or its byproducts.

Like many other bacteria and some fungi, P. aeruginosa “communicate” with each other via something called Quorum sensing (QS). The P. aeruginosa QS molecules are able to turn bacterial genes on and off, such as instructing the bacteria to form biofilms under certain circumstances. Just as people with normal immune systems interact with P. aeruginosa without incident, people with normal immune systems also interact with the P. aeruginosa QS molecules without incident.

However, one of the possible ideas explored in Nature’s Quinolones: The 4Qs is that people who have been “floxed” may not react to the P. aeruginosa QS molecules without incident. Rather, perhaps they may be sensitized to the P. aeruginosa QS molecules, and their immune-system attacks these molecules, causing a potential autoimmune/neuroimmune reaction.

Why might “floxies” have an immune-system over-reaction to P. aeruginosa QS molecules?

Because one group of QS molecules that P. aeruginosa QS makes are actually quinolones–“nature’s quinolones” (heterocyclic 4-quinolone/quinolines – abbreviated the “4Qs”). These 4Qs produced by P. aeruginosa share the basic 4-quinolone backbone of the commercially synthesized quinolone antibiotics. (More information about this can be found in Nature’s Quinolones: The 4Qs, as well as the articles linked-to in the post, including 4-Quinolones: Smart Phones of the Microbial World.)

I don’t know about you, but this BLEW MY MIND.

The production of natural quinolones may answer the question – why do people have ongoing reactions to fluoroquinolone antibiotics that last long after the drugs “should” be out of their system? Could it be because they are constantly being re-exposed to quinolones in our environment–through a common bacteria producing them to communicate with other bacteria? Could it be that Fluoroquinolone Toxicity is an ongoing syndrome because it is an immune reaction (and/or sensitization) to chemicals that are ubiquitous in our environment?

Again, these are just possible ideas the author of  Nature’s Quinolones: The 4Qs is exploring, but it MAKES SO MUCH SENSE.

QS Qinolones act as “signaling molecules for other bacteria. FQs also act as “signaling molecules” within us. In particular, they seem to target cytokines, which are heavily involved in the signaling and amplification system in our immune systems.” Pharmaceutical fluoroquinolones are given in a large enough doses that perhaps they may signal the immune system to over-react–especially to the presence of other quinolones. Nature’s Quinolones: The 4Qs describes some possible mechanisms through which fluoroquinolones may affect the immune system, providing numerous references in additional links in the article supporting this. Fluoroquinolones (and/or the 4Qs if production in larger amounts due to severe infection such as sepsis, for example) may also trigger epigenetic “switches” to be “flipped” in the immune system, causing a change that leads to a constant over-reaction to quinolone molecules.

The author of Nature’s Quinolones: The 4Qs ponders:

“I wonder if some of my existing natural antibodies were “switched on” in a major way, leading to global or specific hypersensitivities. And based on what I now know about FQs acting as ‘signaling molecules,’ I’m guessing that one or more of my cytokines or receptors were hit especially hard by what my body perceived as a whopping dose of quinolones.”

An over-active immune system that is hyper-sensitive to minute amounts of molecules that are harmless, and even unperceived, to people with normally functioning immune systems, is not unheard-of. Many people with ME/CFS believe they have autoimmune/neuroimmune reactions to tiny molecules of mold, and even minuscule amounts of mold appear to make them severely ill. Common allergies are also a result of an over-sensitized immune system:

“If this seems like an extreme leap to make, consider, for example, two very common allergies: hay fever and peanut allergies. There are microscopic particles of pollen and dust floating around in the air that most of us never see, feel, are aware of, or react to – unless you’re a person with hay fever allergies. There are microscopic proteins and aflatoxins in peanuts that most of us never see, feel, are aware of or react to – unless you’re a person with a peanut allergy. The first allergy typically leaves people with itchy and runny eyes and nose. The second allergy can result in anaphylaxis and even death. The point being, it doesn’t take much of these substances to make a person miserable or even kill them – if they’re hypersensitive.”

Might some people suffering from fluoroquinolone toxicity be sensitive to minute amounts of quinolones in the environment? Might some people who live in more humid and moist environments, for example, have increased exposure to quinolones by P. aeruginosa QS molecules? Additionally, might the fluoroquinolones have made epigenetic changes to the immune systems of those suffering from fluoroquinolone toxicity that make them have autoimmune/neuroimmune-like reactions to quinolones, including the 4Qs? Again, it makes all the sense in the world to me, but it needs to be examined by someone with the capacity to test these ideas.

If fluoroquinolones change the genetic on/off switches in our immune systems, how do we flip those epigenetic “switches” again? That’s a very good question that I don’t know the answer to. Our environment is constantly affecting our genes though, and epigenetics is a burgeoning field of research. I’m hopeful that scientists will find targeted ways to flip gene switches. I’m also hopeful that, in the meantime, changes in your environment (eating healthy foods, reducing stress, supplements, etc.) may help you (the “floxie” reading this) to “switch” your immune system back to where you were pre-flox so that your body is not over-reacting to nature’s quinolones (if that’s occurring). I know that my body is not in a state of constant reactivity, and, as always, I hope that my recovery gives others hope for their recovery.

********

 

 

Fluoroquinolone Toxicity Featured in NATURE

Fluoroquinolone toxicity is highlighted and featured in NATURE – one of the oldest, most reputable, journals in the world. This is so exciting!!

You can read the article, When antibiotics turn toxic, that was published in Nature on March 21, 2018 HERE.

Here are some highlights from the Nature article:

First, thank you to Dr. Miriam van Staveren whose story was told in the Nature article. She is a physician and a fellow “floxie.” Even as a physician, she had trouble getting her experience of being poisoned by Levofloxacin acknowledged:

“Since then, she has seen a variety of medical specialists. Some dismissed her symptoms as psychosomatic. Others suggested diagnoses of fibromyalgia or chronic fatigue syndrome. Van Staveren is in no doubt, however. She’s convinced that the antibiotic poisoned her.”

Second, the article mentions Fluoroquinolone Toxicity and Fluoroquinolone Associated Disability (FQAD) by name. This is huge! Rather than calling what we are experiencing something like, “a rare adverse reaction,” it is referred to as fluoroquinolone toxicity or FQAD. This is subtle acknowledgement that what we are going through is a syndrome–a thing in itself–not just a “side-effect” to be dismissed.

Third, even though the word “rare” is used throughout the article, and I know that this is annoying and off-putting for all of us who see that fluoroquinolone toxicity is NOT RARE, the article also notes that the frequency of fluoroquinolone toxicity is higher than many assume:

“From the 1980s to the end of 2015, the FDA received reports from more than 60,000 patients detailing hundreds of thousands of ‘serious adverse events’ associated with the 5 fluoroquinolones still on the market (most commonly tendon rupture, as well as neurological and psychiatric symptoms), including 6,575 reports of deaths. The FDA says that the reports of adverse events it receives — sent in by drug manufacturers, by doctors and directly by consumers — cannot be used to reach conclusions about the severity of problems associated with drugs. Still, the fluoroquinolones have attracted more complaints than other more widely used antibiotics. And only 1–10% of adverse events are estimated to be reported to the FDA, suggesting that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, a haematologist at the University of South Carolina’s College of Pharmacy in Columbia. Bennett is also director of the Southern Network on Adverse Reactions, a state-funded pharmaceutical-safety watchdog, which has been working with people affected by fluoroquinolones since 2010.”

Fourth, mitochondrial damage is noted as a cause of fluoroquinolone toxicity:

“Accumulating evidence, Golomb says, suggests that fluoroquinolones are damaging mitochondria, the power packs inside human cells that evolved from symbiotic, bacteria-like cells billions of years ago. This kind of harm can affect every cell in the body, explaining why a wide range of symptoms can appear and get worse over time.”

Fifth, the article noted that Dr. Charles Bennett, may have found some genes shared by people who are hurt by fluoroquinolones:

“At a conference last September, Bennett reported preliminary data that might hint at why only some people develop serious side effects from fluoroquinolones. He took saliva samples from 24 people who reported neuropsychiatric side effects — such as memory loss, panic attacks and depression — and found that 13 of them (57%) shared a gene variant usually seen in only 9% of the population.”

If there are genes that make people more succeptible to disabling fluoroquinolone toxicity, perhaps those can be tested for before fluoroquinolone prescriptions are written.

Sixth, the article notes the obstacles that scientists, researchers, and doctors face when they question and investigate adverse drug reactions. It is noted that little support or funding for adverse drug reaction research is available, and that many scientists face push-back from pharmaceutical companies when they attempt to research fluoroquinolone toxicity.

Last, Floxie Hope was mentioned in the article. Squeee! What an honor and a privilege to be mentioned in an article in Nature!

“On websites and Facebook groups with names such as Floxie Hope and My Quin Story, thousands of people who have fallen ill after fluoroquinolone treatment gather to share experiences. Many of them describe a devastating and progressive condition, encompassing symptoms ranging from psychiatric and sensory disturbances to problems with muscles, tendons and nerves that continue after people have stopped taking the drugs. They call it being ‘floxed’.”

Those seven points are the highlights of the article, in my opinion, but I suggest that each of you read the article yourself. It’s currently (03/25/18) on the home-page of nature.com. Squee!

*****

 

A Delicate Balance: Fluoroquinolones Disrupt Cellular Homeostasis

This post was inspired by, “My Father’s Body, at Rest and in Motion: His systems were failing. The challenge was to understand what had sustained them for so long.” by Siddhartha Mukherjee, published in the January 8, 2018 issue of The New Yorker. (When not noted otherwise, all quotes are from “My Father’s Body, at Rest and in Motion.”) It’s a poignant personal account of Dr. Mukherjee’s father’s decline and death. It is also about the beautiful and delicate balance that is life. I cannot do the article justice in taking excerpts from it, and I suggest that you read it yourself. It is only related to fluoroquinolone toxicity peripherally (if at all), but I think there are lessons to be learned about fluoroquinolone toxicity within it. There are certainly lessons about life, and death, within it, and I recommend it to anyone who likes thoughtful, New-Yorker-esque articles.

I never thought about cellular homeostasis before I got floxed. Who, other than biochemists and med students, thinks about cellular homeostasis?

“There’s a glassy transparency to things around us that work, made visible only when the glass is cracked and fissured. Look, it’s nothing. To dwell inside a well-functioning machine is to be largely unaware of its functioning. That’s its gift, and we accept it thoughtlessly, ungratefully, unknowingly.”

Homeostasis, the ability to maintain internal consistency, is crucial for life. Indeed, “Homeostasis, the capacity to maintain a functional equilibrium, would turn out to be one of the cardinal principles of all organisms; it’s often described as one of the defining principles of life.” The dance within our cells that maintains homeostasis, that keeps us functioning properly, that keeps each feedback and feed-forward loop operating optimally, is necessary for health, and for maintaining life.

Fluoroquinolones disrupt cellular mineral levels, the balance of antioxidants and ROS within cells, hormonal balance, gut biome balance, and more. They cause mitochondrial apoptosis, and nervous system dysfunction. Fluoroquinolones disrupt homeostasis—the delicate balance and intricate dance of keeping minerals, hormones, vitamins, etc. in-balance within our cells. Fluoroquinolones disrupt crucial functions, and in doing so, throw a wrench in health, and in life.

What happens when homeostasis is disrupted by fluoroquinolones?

The answer seems to depend on multiple factors. How many physiological processes were disrupted? To what extent? Where? What feedback and feed-forward loops were triggered? What is the downstream damage? What are the genetic (and other) predispositions of the individual who has been hurt? What is the ROS/MMP burden on the body/cell at the time that a person takes ciprofloxacin or levofloxacin? What are the hormone levels at the time that a person takes the pill(s)? What are the compensating factors that make a person stronger or more resilient? What makes someone vulnerable? Who? What? How?

In theory, we can know the answers to these questions. In practice though, we can’t, and a certain amount of luck, or lack thereof, enters the equation. We cannot know the answers to those questions before we take any pharmaceutical, and thus, we are playing Russian Roulette with our bodies when we take drugs like fluoroquinolones that disrupt multiple systems, and cause disrupted cellular homeostasis.

“Indeed, once self-regulation fails, complex systems of all kinds can be claimed by a version of this process, sometimes called a failure cascade. A storm-battered tree takes down a transmission line; the increased load causes another network component to fail, further increasing the load, turning a local outage into a regional blackout. The failure of one division in one bank can trigger a global cataclysm. That’s a failure cascade.”

Perhaps the difference between a person who takes multiple fluoroquinolone prescriptions without notable effect and a person who experiences severe toxicity and even death, is whether or not the fluoroquinolones throw a person into a “failure cascade.” Homeostasis can be disturbed a bit with no notable effect (our healing and stability mechanisms kick in), but if it is disturbed enough to throw a person into a “failure cascade” everything goes wrong in his or her body, and it feels as if a bomb has exploded.

“Yet maintenance defies measurement; it’s the glass pane that’s visible only when it cracks. In the several months of my father’s decline, hospitalization, and death, we recorded the values of hundreds of things in his body: potassium, temperature, breathing rate, creatinine, bicarbonate, chloride, the oxygen saturation of his blood, the output of his urine. What we didn’t measure—couldn’t measure—was how hard his body was working to bestill these values, how much “unnatural vigilance” was required to keep things steady, and how deeply his physiology must have collapsed when the numbers finally dipped into abnormalcy. We had, in short, no real measure of homeostatic resilience, of physiological reserve.”

In “My Father’s Body, at Rest and in Motion” Dr. Mukherjee is writing about his elderly father, whose body is failing because of old-age and a bad fall. As difficult as it is for the elderly people (and their loved ones) who enter a “failure cascade” due to old-age and/or trauma, it is expected that old-age brings bodily failures, and that some of those failures will lead to other failures. We expect that time will disrupt homeostasis and that our cellular functions will eventually fail. But we don’t expect that a drug—a popular antibiotic no less—will trigger a “failure cascade.” They do though. Ciprofloxacin, levofloxacin, moxifloxacin, and other fluoroquinolones trigger multi-symptom, chronic, disabling illness—often in young people.

How do people who have been hurt by fluoroquinolones get back to a healthy state of cellular homeostasis? How do you stop the feedback loops that are leading to the “failure cascade?” I don’t know the answer for any individual, and nothing on this site should be interpreted as medical advice (I’m not a doctor), but some basic advice, that seems to have helped other people, can be found in the post, I’m Floxed, Now What? 

It struck me as I read “My Father’s Body, at Rest and in Motion” just how little we (collectively–including doctors and scientists) know about health, or even life (not how to live life, but the actual process of life, and our cellular processes that are at the center of life). Health, healing, and even life, are things that are easy to take for granted, and to fail to study or even notice, until they go away or are threatened. I barely thought about my health, much less my cellular homeostasis, until it was threatened by ciprofloxacin. After I got “floxed” I had a reason to notice how delicate and precarious my health was. Health and its basis of homeostasis are both robust and delicate. Our feedback and feed-forward loops work as they should–until they don’t. Without homeostasis, without the processes that compose life working the way they should, life ceases. Fluoroquinolones disrupt homeostasis, and cause many physiological systems to go hay-wire. The damage that fluoroquinolones do can be severe–particularly if a “failure cascade” is triggered. With every fluoroquinolone pill taken, damage is done, and the risk of a “failure cascade” occurs. Nothing is worth risking a “failure cascade” if that cascade results in death, and very few “floxies” would say that treatment of their infection was worth the pain and disability caused by fluoroquinolones. We may not fully understand the delicate balance of life, or the processes occurring in our cells, but they are important none-the-less, and throwing a wrench in them with fluoroquinolones is both damaging and foolish. 

 

 

Persistent Fluoroquinolones in the Body and Delayed Adverse Reactions

This is a guest post written by Gary. You can read Gary’s story HERE. It contains a wonderful wealth of knowledge, insight, and advice. 

Fluoroquinolone side effects are often multisymptom affecting a wide range of bodily functions, ie: CNS, Muscles, Tendons, Brain, etc (Halkin, 1988l Mattappalil and Mergenhagen, 2014; Menzies et al., 1999; Moorthy et al., 2008; Thomas and Reagan, 1996; etc)

The chronic, often multisymptom, effects are not well documented and are normally assigned (often multiple) different diagnosis by doctors, such as clinical depression, fibromyalgia, etc/ (Strauchman and Morningstar, 2012)

I argue the reason for the chronic effects is because the Fluoroquinolones are not metabolized correctly, or the are metabolized and the normal biological enzymes that are responsible for detoxification of xenobiotic substrates is impared. A xenobiotic is a synthetic chemical such as Levaquin, Cipro, pestacides, etc. It’s also likely that FQ exposure changes gene expressions relating to various cytochrome P-450s (which is responsible for metabolizing and detoxification) causing your body to accumulate toxic chemicals, being unable to remove them.

For example, According to Liang et al., (2015), Fish that were exposed to a specific FQ had changes to cytochrome P450 1A (CYP1A), cytochrome P-450 3A (CYP3A), glutathione S-transferase (GST), P-glycoprotein (P-gp), which are all responsible for metabolizing and/or removal of xenobiotics. Other animals exposed to FQs were shown to have changes in cytochrome P-450 sites – For example, Dogs exposed to FQs showed inhibiting only cytochrome P-450 3A (Regmi et al., 2005; 2007), Chickens (Shlosberg et al., 1997; Granfors et al., 2004). To be fair, this might not affect humans completely, but this would likely explain the delayed toxicity to the CNS and other parts of the body – Delayed toxicity for FQ patients are likely a result of impared detoxification pathways due to FQ exposure overall which means the body has a high level of xenobiotics that cannot be removed.

There are even a few case studies on /people/ to support this article. In a paper (Strauchman and Morningstar, 2012), a patient was prescribed Moxifloxacin in 2005 and developed a worsening set of symptoms (after inclusion of medication), such as episodic tachycardia, episodic dizziness, episodic shortness of breath, and chronically swollen glands. Additional symptoms included daily episodes of nausea, sweating, tremors, brain fog, blurred vision, panic attacks, and phonophobia. Over the course of 3 years, after Moxifloxacin treatment, her condition improved, modestly.

In 2011, the PCP diagnosed the patient with diverticulitis and prescribed her ciprofloxacin 500 mg – Over the course of the treatment, she started to experience all the previous symptoms from 2005 – including panic attacks, insomnia, blurred vision, tachycardia, and nausea. This episode additionally included diffuse musculoskeletal joint pain. The patient also reported that her elbows, wrists, and knees seemed to crack too easily and too often. (p.3). Full workup was ordered, including genetic testing which showed the following:

– Genetic polymorphism in the cytochrome P-450 pathway

– Genetic variations in the catechol-o-methyl transferase enzyme, the Nacetyl transferase enzyme, and the glutathione-s-transferase enzyme necessary for glutathione conjugation and phase II detoxification.

The patient was also tested for polychlorinated biphenyls and other volatile solvents. They found the patient to have elevated levels of ethylbenzene, xylene, and the pesticide dichlorodiphenyldichloroethylene. Although these levels could indicate environmental accumulation, impaired detoxification pathways may make this accumulation more of a contributing factor.

Fluoroquinolone treatment seems to affect enzymes possesses, causing reduced activity due to chelation of ions, such as Se2 [Selenium], Mg2 [Magnesium], Fe2/3+ [Iron] (Badal et al., 2015; Uivarosi, 2013; Seedher and Agarwal, 2010) which explains the chronic issues, as well as delayed toxicity (due in part to impaired detoxification)

Even more evidence that either FQs remain in the body, impairing detoxification of xenobiotics (or they contribute to impairment) is from a journal (Cohen, 2008) where a patient was on a 14 day course of Moxifloxacin and became disabled, for many years; His symptoms were Brain Fog, Cognitive Defects/memory loss, tingling and numbness in his legs, joint pains, Achilles pain, Chronic Fatigue, Weakness, to a degree that he could barely stand or walk; The patient began IV Based Antioxidant therapy, and his condition improved considerably (95%+ recovery within a month). It’s highly likely that the IV Antioxidant therapy activated/modulated cytochrome P-450 to allow the patients body to excrete the excessive, normal environmental xenobiotics (and including Moxifloxican) and the patient recovered.

Fluoroquinolones have a very high melting point, over 200C, which means the crystals they form are very stable in neutral pH. (Andriole et al., 2000). If FQs are stuck within the cells, then that means they are responsible with mitochondrial ETC leakage, causing depressed health effects (ie: Brain Fog from FQ exposure is likely caused by FQs interfering with ATP energy output, which affects the Brain’s homeostasis).

What causes the delayed toxicity? There are only 3 possible explanations.

– You have pre-existing genetic polymorphisms in cytochrome P450s (and others) that prevent you from metabolizing and/or excreting FQs – Which leads to various normal systems in the body to suffer for a long period of time. (FQ crystals are ‘stuck’ in your body)

– FQs /cause/ the polymorphisms because they chelate heavy metals that enzymes require for proper biological function, such as phase II detoxification. Once this happens, your body begins to accumulate xenobiotics and you develop delayed toxicity.

– FQs cause mitochrondia dysfunction with organs responsible for generting glutathione, causing your body to have extremely low levels of glutathione, leading to increased amounts of xenobiotics that you cannot remove.

If this behavior takes place, how do we prove it?

– Genetic testing is the only way to be sure you have these Genetic polymorphisms/Genetic Variations – Some sites out there do provide this.

– Liquid Chromatography-tandem mass spectrometry will need to be performed on blood samples from people currently damaged by FQs to see if any concentrations of it exist in plasma.

– Total GSH testing would likely show lower-than-expected glutathione levels in the body with someone that is disabled, because if FQs are embedded in the cells, they are likly decreasing ATP output of various organs.

How would we remove the FQs that are ‘stuck’ in the body?

– Ozone is able to remove FQs from water (Feng et al., 2016). Therefor, Ozone therapy might be an idea If this behavior of FQs takes place.

– Fluoroquinolones have a Michael acceptor in them, making them very electrophilic. The non-aromatic double bond could potentially be subject to nucleophilic attack via a Michael addition, so one removal strategy could be allowing ligating the fluoroquinolone/associated polymorphs to something that is readily transported across cell membranes and excreted. However, this would need to be drawn up on a computer simulation to see if this could be done, cost effectively.

– Prolonged IV Antioxidant therapy, as shown above, seems to reverse FQ toxicity in some patients but further testing will need to be done (A heavy metal toxscreen via blood to be tested for chemical insult will likely need to be ordered)

Pharmacogenomics is going to likely show who is compatible with FQs and who isn’t, down the road–once we identify specific SNP’s that are broken with us floxies, the /good/ news is, with CRISPR technology, those of us with pre-existing polymorphisms (pre/post-FQ) will likely be able to have them corrected with little to no side effects.

Data from the following:

Strauchman M, Morningstar MW. Fluoroquinolone toxicity symptoms in a patient presenting with low back pain. Clinics and Practice. 2012;2(4):e87. doi:10.4081/cp.2012.e87.

N. L. Regmi, A. M. Abd El-Aty, R. Kubota, S. S. Shah, and M. Shimoda, “Lack of inhibitory effects of several fluoroquinolones on cytochrome P-450 3A activities at clinical dosage in dogs,” Journal of Veterinary Pharmacology and Therapeutics, vol. 30, no. 1, pp. 37–42, 2007.  ·  ·

N. L. Regmi, A. M. Abd El-Aty, M. Kuroha, M. Nakamura, and M. Shimoda, “Inhibitory effect of several fluoroquinolones on hepatic microsomal cytochrome P-450 1A activities in dogs,” Journal of Veterinary Pharmacology and Therapeutics, vol. 28, no. 6, pp. 553–557, 2005.  ·  ·

M. D. Brand, R. L. Goncalves, A. L. Orr et al., “Suppressors of superoxide-H2O2 production at site IQ of mitochondrial complex I protect against stem cell hyperplasia and ischemia-reperfusion injury,” Cell Metabolism, vol. 24, no. 4, pp. 582–592, 2016.  ·  ·

M. A. Simonin, P. Gegout-Pottie, A. Minn, P. Gillet, P. Netter, and B. Terlain, “Pefloxacin-induced Achilles tendon toxicity in rodents: biochemical changes in proteoglycan synthesis and oxidative damage to collagen,” Antimicrobial Agents and Chemotherapy, vol. 44, no. 4, pp. 867–872, 2000.  ·  ·

Krzysztof Michalak, Aleksandra Sobolewska-Włodarczyk, Marcin Włodarczyk, Justyna Sobolewska, Piotr Woźniak, and Bogusław Sobolewski, “Treatment of the Fluoroquinolone-Associated Disability: The Pathobiochemical Implications,” Oxidative Medicine and Cellular Longevity, vol. 2017, Article ID 8023935, 15 pages, 2017. doi:10.1155/2017/8023935

J. M. Radandt, C. R. Marchbanks, and M. N. Dudley, “Interactions of fluoroquinolones with other drugs: mechanisms, variability, clinical significance, and management,” Clinical Infectious Diseases, vol. 14, no. 1, pp. 272–284, 1992.

H. H. M. Ma, F. C. K. Chiu, and R. C. Li, “Mechanistic investigation of the reduction in antimicrobial activity of ciprofloxacin by metal cations,” Pharmaceutical Research, vol. 14, no. 3, pp. 366–370, 1997.

N. Seedher and P. Agarwal, “Effect of metal ions on some pharmacologically relevant interactions involving fluoroquinolone antibiotics,” Drug Metabolism and Drug Interactions, vol. 25, no. 1–4, pp. 17–24, 2010.

H. Koga, “High-performance liquid chromatography measurement of antimicrobial concentrations in polymorphonuclear leukocytes,” Antimicrobial Agents and Chemotherapy, vol. 31, no. 12, pp. 1904–1908, 1987.

A. Pascual, I. García, S. Ballesta, and E. J. Perea, “Uptake and intracellular activity of trovafloxacin in human phagocytes and tissue-cultured epithelial cells,” Antimicrobial Agents and Chemotherapy, vol. 41, no. 2, pp. 274–277, 1997.

V. T. Andriole, The Quinolones – Third Edition, Acedemic Press, San Diego California, 2000.

S. Badal, Y. F. Her, and L. J. Maher 3rd, “Nonantibiotic effects of fluoroquinolones in mammalian cells,” The Journal of Biological Chemistry, vol. 290, no. 36, pp. 22287–22297, 2015.

J. Y. Lee, S. H. Lee, J. W. Chang, J. J. Song, H. H. Jung, and G. J. Im, “Protective effect of metformin on gentamicin-induced vestibulotoxicity in rat primary cell culture,” Clinical and Experimental Otorhinolaryngology, vol. 7, no. 4, pp. 286–294, 2014.  ·  ·

Z. K. Salman, R. Refaat, E. Selima, A. El Sarha, and M. A. Ismail, “The combined effect of metformin and L-cysteine on inflammation, oxidative stress and insulin resistance in streptozotocin-induced type 2 diabetes in rats,” European Journal of Pharmacology, vol. 714, no. 1–3, pp. 448–455, 2013.  ·  ·

A. I. Morales, D. Detaille, M. Prieto et al., “Metformin prevents experimental gentamicin-induced nephropathy by a mitochondria-dependent pathway,” Kidney International, vol. 77, no. 10, pp. 861–869, 2010.  ·  ·

W. Chowanadisai, K. A. Bauerly, E. Tchaparian, A. Wong, G. A. Cortopassi, and R. B. Rucker, “Pyrroloquinoline quinone stimulates mitochondrial biogenesis through cAMP response element-binding protein phosphorylation and increased PGC-1alpha expression,” The Journal of Biological Chemistry, vol. 285, no. 1, pp. 142–152, 2010.  ·  ·

T. Stites, D. Storms, K. Bauerly et al., “Pyrroloquinoline quinone modulates mitochondrial quantity and function in mice,” The Journal of Nutrition, vol. 136, no. 2, pp. 390–396, 2006.

Y. Huang, N. Chen, and D. Miao, “Biological effects of pyrroloquinoline quinone on liver damage in Bmi-1 knockout mice,” Experimental and Therapeutic Medicine, vol. 10, no. 2, pp. 451–458, 2015.  ·  ·

M. Feng, L. Yan, X. Zhang et al., “Fast removal of the antibiotic flumequine from aqueous solution by ozonation: influencing factors, reaction pathways, and toxicity evaluation,” Science of The Total Environment, vol. 541, pp. 167–175, 2016

**

Can Floxies Drink Alcohol?

Many people have asked me if they can/should drink alcohol post-flox.

As with most things, the answer is – it depends, and everyone is different.

Some Floxies tolerate alcohol fine, while others don’t.

Alcohol is, of course, bad for you. It’s hard on the liver, and can lead to cirrhosis and alcoholic hepatitis. It burdens your liver’s detoxification abilities and hinders your ability to get rid of other toxins. Alcohol wreaks havoc on the gut microbiome, and can encourage candida growth. Alcohol weakens the immune system, and can make you more succeptible to other illnesses. I could go on and on because there are hundreds of articles about the harm that alcohol inflicts on the human body. No matter how many videos come out about tequila being a probiotic, or articles there are about wine containing resveritrol, alcohol is not a health elixir. It is not good for you.

HOWEVER, it is quite fun (IMO), and it even has some health benefits–it’s a painkiller and it reduces feelings of stress and anxiety. Alcohol has enough redeeming qualities that billions of people around the world, most of whom are aware of the negative effects of alcohol, consume it. I do, and so do many other floxies.

When I first got floxed, I stopped drinking for a while. My body was going hay-wire in every conceivable way, and I didn’t want to contribute to my problems by knowingly consuming a substance that is bad for me. I think that abstaining from alcohol during the acute phase of fluoroquinolone toxicity was the right thing for me to do.

Once my body stabilized (i.e. it stopped feeling like a bomb was going off in my body, and I even had some improved/normal days) I started having a drink every once in a while. Even though I could drink, I found that my tolerance for alcohol was greatly diminished. Before I got floxed I could handle three-ish drinks in an evening (and I thoroughly enjoyed drinking them). After getting floxed, my tolerance was one drink a night (that was barely enjoyable). I didn’t even want to drink more than that–I struggle to explain why, but I just felt done after 3/4 of a drink. Over time (I am now a bit over 5 years post-flox) my tolerance increased, and I can now comfortably have two alcoholic beverages in an evening. That’s plenty for me, in my personal opinion of how much I should/shouldn’t drink.

I never experienced a relapse in fluoroquinolone toxicity symptoms as a direct result of drinking alcohol, but other people have, and I encourage everyone who wants to drink post-flox to be very careful and cautious with alcohol consumption. Comments such as this one, from Bob (and the comment just above it when you click on the link, from Ann), are examples of alcohol triggering an increase in, or relapse of, fluoroquinolone toxicity symptoms:

After getting floxed I had relapses to alcohol which I only drank on vacation. I suspect this is due to severe kill off of gut flora. I am afraid to drink anymore.

This comment from Mark also notes that alcohol consumption can lead to fluoroquinolone toxicity symptom flares:

I cheated this weekend and drank alcohol/ate dairy. You know what? It flared up my cipro symptoms full force. Knee joints started cracking like crazy, achilles heal flare, etc. I’m convinced that we are all suffering an overgrowth of yeast and the faster we can get that under control, the healthier we will be.

Some people have a more moderate reaction to alcohol post-flox. This comment, from Ruth, is really interesting and insightful. Though she can drink alcohol without issue, she typically abstains:

I am able to drink again but my tolerance is greatly reduced. It won’t actually harm your gaba receptors because alcohol acts on gaba-b instead of gaba-a. I think it promotes healing.

When the alcohol downgrades the gaba-b subunit, I think the body makes repairs to some of the a subunits in order to put things back in balance.

I think when the FQ took out some of your gaba-a receptors your body gave you extra gaba-b receptors. This can make you a lot more receptive to the effects of alcohol. The b unit seems to be able to replace itself faster. That’s why alcohol withdrawal lasts a lot less long than benzodiazepine withdrawal. This is all just my theory. I have nothing to back it up with except my own experience.

Last year I got drunk at the Racine Zoo by accident. They hosted a teacher’s night and served spiked punches with no indication that they were alcoholic. I had what they had labeled as “Lesson Learned Lemonade.” I was thirsty so I slammed a big cup. At first I felt super relaxed and I thought that my nervous system must really be healing. Maybe it was that walk on the beach… and then I felt it. I knew it had been alcoholic. I ended up drunk off my ass, but not so bad that I couldn’t say “gamma amino butyric acid,” ha, ha. I got a brief relapse from that experience, of symptoms I had not had in a long time. After that ended my base line seemed higher.

So I think alcohol is not completely bad. However, it can devastate your gut microbiome, so I am very careful about it. I had a tiny tiny bit of Bailey’s at Christmas. I enjoyed it. Other than the holidays I abstain from alcohol for the sake of my healthy flora.

Although it won’t stop your nervous system from healing, remember that psych symptoms can also stem from an imbalance of healthy vs. unhealthy microbes. Alcohol can worsen that situation considerably so for the foreseeable future it is better to abstain. Farther down the road you will probably be able to have a beer now and then with no ill effects.

Some people have even found that alcohol has helped them. It is a pain reliever and relaxant. It reduces anxiety and stress – even the anxiety and stress that comes with getting poisoned by a pharmaceutical. Stress and anxiety reduction are crucial for healing from fluoroquinolone toxicity. Both Bronwen and Barbara noted that they felt better with moderate alcohol consumption.

Bronwen’s Comment:

As far as booze goes, I actually found one drink helped lessen my symptoms a bit when they were getting overwhelming in the evening – much to my surprise, but I have only ever read one other person that found the same thing – most find the opposite. Again, test yourself! I certainly could not have more than one drink. The liver is struggling along with the other organs, as the clearing house for toxins, so alcohol puts another burden on it.

Barbara’s Comment:

My saving grace is I am allowed wine 😁😁 hallelujah .I have been able to drink alcohol from the begining and in certain times when the pain was bad I swear it helped.

As you can see, reactions to alcohol post-flox vary considerably. So, what should your take-away from this post be? Should you drink alcohol, or not? I can’t answer that for you, because I have no idea how you respond to alcohol, or how much you enjoy consuming it. If alcohol isn’t your drug of choice, and you don’t particularly like it, don’t start drinking because some people have responded positively to its benefits. If you want to drink alcohol, it is, of course, best to do it in moderation. If you want to avoid all things that may trigger a relapse, or that are generally bad for the body, by all means, don’t drink. As with all advice for my floxie friends – it depends, everyone is different, and be careful.

 

Write for Floxie Hope

Are you interested in sharing thoughts, opinions, or advice with others in the “floxie” community? Would you like to use the Floxie Hope platform to reach your fellow floxies?

If so, I would like to invite you to write a guest post for www.floxiehope.com (this site).

There is so much wisdom and insight in this community. I see thoughtful and insightful posts in the comments on this site, and in the various facebook groups that focus on supporting victims of fluoroquinolones. Unfortunately, so many wonderful, valuable comments (either on this site, or on social media) get lost as newer comments rise to the top. One way to preserve thoughtful comments is to turn them into blog posts on floxiehope.com.

I welcome all insights into fluoroquinolone toxicity to be published on floxiehope.com. Hopeful posts, or those about your recovery journey, or things that have helped you, are of course welcome. I want this site to have hope and recovery as its base. However, I also welcome posts that explore the less hopeful aspects of fluoroquinolone toxicity. If you want to write a summary of a journal article about fluoroquinolone damage, or if you want to write a post that connects the symptoms of, for example, fluoroquinolone toxicity to lupus, I’m happy to publish something like that too. I’m open to other suggestions as well.

If you are interested in writing a post for floxiehope.com, please contact me through this form:

Thank you in advance for any consideration that you give to contributing to floxiehope.com! All contributions to this site are greatly appreciated!

 

 

 

Floxie Hope Podcast Episode 24 – PJ

PJ shared his journey through fluoroquinolone toxicity on Episode 24 of The Floxie Hope Podcast. Check it out!

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

PJ was given IV levofloxacin/levaquin and flagyl in the hospital, and afterward he suffered from multiple severe side-effects including debilitating fatigue, peripheral neuropathy, body-wide numbness, pain, inflammation in all his joints, and more.

He has come a long way, and he is 80% recovered.

PJ is wonderfully insightful and inspirational. Please listen to, review, and share, this episode of The Floxie Hope Podcast. Thanks!!

 

 

 

 

Fluoroquinolones Increase Risk of Aortic Aneurysm

Evidence is mounting that fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin, and their generic equivalents) increase the risk of aortic aneurysm and dissection, yet the FDA is denying the connection between fluoroquinolone use and the potentially deadly vascular conditions.

In a May, 2017 notice on fda.gov, the FDA stated:

“As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection. We will continue to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.”

This statement was made after two major studies were released, showing the statistically significant increase in risk of aortic dissection and aneurysm with fluoroquinolone use. “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” (JAMA Internal Medicine, 2015), and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” (BMJ Open, 2015) both found that fluoroquinolone use is associated with an increased risk of aortic aneurysm and dissection, with “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” concluding that:

“Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection. While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”

Both “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone” and “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” are major studies, with “analysis of 1477 case patients and 147 700 matched control cases from Taiwan’s National Health Insurance Research Database (NHIRD) from among 1 million individuals longitudinally observed from January 2000 through December 2011” for the former, and 1.7 million older adults in Ontario, Canada, for the later. They are robust studies that show a statistically significant association between fluoroquinolone-use and aortic aneurysm and dissection.

Still, the FDA doesn’t acknowledge that there is a connection between fluoroquinolone-use and these potentially deadly disorders.

Before you defend the FDA by saying something like, “correlation doesn’t mean causation,” or, “an association doesn’t prove anything,” think about what it would take to do a study that would actually show a causal link between fluoroquinolones and aortic dissection and aneurysm–researchers would have to intentionally expose a group of people who they knew were at-risk for aortic dissection and/or aneurysm to Cipro, and another group of people who presumably had an infection to a placebo, then see whether or not they were hurt or died from the exposure. You can’t do this experiment on humans for fairly obvious reasons.

However, you can do the experiment with mice, and a team of researchers from Baylor College of Medicine, the Texas Heart Institute, and Baylor College of Medicine’s Cardiovascular Research Institute, “found that ciprofloxacin, a widely prescribed antibiotic, increases the risk of tears and rupture on the main artery of the body, the aorta, in a mouse model of human aortic aneurysms and dissections (AAD), a disease that carries high risk of death from aortic rupture.” (source) The study showed that:

“normal, unstressed mice treated with ciprofloxacin did not show significant negative effects on the aorta. In mice with moderately stressed aortas that had received the placebo, 45 percent developed AAD, 24 percent developed aortic dissection and none had rupture. On the other hand, 79 percent of the mice with moderately stressed aortas that received antibiotic developed AAD, 67 percent had aortic dissection, and 15 percent had fatal rupture. These results were similar in males and females.” (source)

Though mice with normal aortas weren’t negatively affected by the Cipro exposure, those with stressed aortas were harmed–some fatally. These results, combined with the human population-based longitudinal cohort studies noted above, show, as strongly as we can without subjecting humans to unethical experiments, that fluoroquinoloes (or at least Cipro), increase the risk of aortic aneurysm and dissection in those with previously stressed aortas.

To further their case that fluoroquinolone-use led to aortic aneurysm and dissection, the Baylor researchers also explored the mechanism(s) through which Cipro/ciprofloxacin damages the extracellular matrix, and contributes to the weakening of aortic tissues:

“The researchers then looked deeper into the effects of ciprofloxacin on mouse aortas searching for insights into the antibiotic’s mechanism of action. Compared with the aortas from stressed mice treated with the placebo, the aortic tissue of stressed mice treated with the antibiotic showed more destruction and fragmentation of elastic fibers; decreased activity of LOX, a key enzyme involved in stabilizing the extracellular matrix; increased activity of MMP enzymes involved in extracellular matrix degradation; and enhanced activation of cellular pathways that lead to cell death. Separate laboratory experiments on human aortic smooth muscle cells revealed that sustained ciprofloxacin exposure reduced the expression of LOX while enhancing the expression of MMP and inducing cell death. In these experimental settings, the antibiotic is disrupting the natural processes that maintain the integrity of the extracellular matrix that is essential for normal aortic function.” (source)

Links to studies that show that fluoroquinolones increase expression of damaging MMP enzymes, as well as oxidative stress, can be found in the posts, “Fluoroquinolones Increase Expression of MMPs” and “Antioxidant Depletion by Fluoroquinolones.

The evidence that fluoroquinolones increase the chance of aortic aneurysm and dissection in succeptible individuals is significant. The large population-based studies are compelling, the mouse study establishes a stronger causal link, and many studies that show the damaging effects of fluoroquinolones on cell, collagen, and extracellular matrix, health, each add weight to the argument that fluoroquinolones are contributing to potentially deadly aortic aneurysm and dissections. Yet, the FDA is still claiming that studies don’t support a connection. I’m not sure what else they need in order to convince them that aortic aneurysm and dissection are, indeed, linked to fluoroquinolones. The evidence seems strong and compelling to me, and I suspect that they are just wrong.

Additionally supporting the link between fluoroquinolones and aortic aneurysm and dissection are personal testimonials of connections and damage done. In comments on the post, “Hurt by a Generic Drug? Victims have no Recourse unless the FDA Changes Rules,” published on hormonesmatter.com, one person noted that:

“I took a generic levaquin, a week or so later I had an aortic dissection. It was descending so it was not fixed by surgery. I now have an aortic aneurysm. The tear is pasted together with blood clots. A CT scan every 6 mos to check the size of the aneurysm. Keep my bp below 120.”

Another responded that:

“Took generic Leviquin 7 weeks later aortic dissection. Tore 2 layers of muscle from over my aortic valve down thru and ended in my thighs. Doctor said I would not survive operation. Tear was so big over the valve had to put in synthetic patch.”

In testimony to the FDA, Sherry Reiver stated:

“Four years ago today, my 93 year old dad died. He FELL at home and was taken to the hospital by a neighbor. By the time my husband and I arrived in Florida, my dad had no idea who we were. They THOUGHT he had pneumonia so they IV’d him with Levaquin. It turned out that he did NOT have pneumonia but he continued to hallucinate for 6 weeks and then died. He was sharp as a tack before Levaquin dripped into his body. He did have an aortic aneurysm for many years which was being watched but it ruptured on November 4th. I would have never connected the AA with FQs until I read this research paper dated October 5th 2015. So here is another RARE side effect that can occur, which it did in my dad’s case. How many others have died from AAs and had taken a FQ drug?”

There is significant evidence that fluoroquinolones contributed to these aortic aneurysms and dissections, as well as those of thousands of other patients. These patients weren’t warned that fluoroquinolones could increase their chances of aortic aneurysm or dissection, and they haven’t had the opportunity to gain retribution or justice, in part because the FDA has failed to acknowledge the connection between fluoroquinolones and aortic aneurysm and dissection.

With the publishing of the Baylor mouse study, I hope that the FDA will acknowledge the connection between fluoroquinolone use and aortic aneurysm and dissection. I also hope that acknowledgement from the FDA will lead to justice for victims, and pain for the pharmaceutical company perpetrators who produce and market these dangerous drugs.

Also, all of the studies that connect fluoroquinolones to aortic aneurysm and dissection are greatly appreciated, and I want to thank all of the researchers and scientists who conducted the studies, as well as those who fund them. Research into adverse drug reactions, and patient safety, are important. All of the researchers and scientists who look into adverse drug reactions, especially fluoroquinolone reactions, are appreciated, and I thank them sincerely.

 

 

 

 

Fluoroquinolones Increase Expression of MMPs

Fluoroquinolones degrade both the cellular matrix and collagen, and degradation of both are related to all the symptoms of fluoroquinolone toxicity. Torn tendons, nerve damage, and even memory loss and aging can be linked to cellular matrix and collagen degradation.

One theory as to how fluoroquinolones cause cellular matrix and collagen degradation (and tendon ruptures, and the hundreds of other symptoms of fluoroquinolone toxicity) is by selectively increasing expression of matrix metalloproteinases, or MMPs.

The article, “Clinical implications of matrix metalloproteinases” notes that:

“Matrix metalloproteinases (MMPs) are a family of neutral proteinases that are important for normal development, wound healing, and a wide variety of pathological processes, including the spread of metastatic cancer cells, arthritic destruction of joints, atherosclerosis, pulmonary fibrosis, emphysema and neuroinflammation. In the central nervous system (CNS), MMPs have been shown to degrade components of the basal lamina, leading to disruption of the blood brain barrier and to contribute to the neuroinflammatory responses in many neurological diseases.”

Information about the effects of fluoroquinolones on the cellular matrix, collagen, and MMPs can be found in these articles:

Though un-doing the damage caused by MMP expression from fluoroquinolones is easier said than done, there are some natural MMP inhibitors that may be helpful.

Chondroitin sulfate inhibits MMPs. Several marine animals contain chondroitin sulfate, and it can be found in shark cartilage, sea cucumbers, as well as marine heparin extracted from shrimp and sea squirt (source). According to the article, Angiogenic inhibitor protein fractions derived from shark cartilage, “Shark cartilage has been proven to have inhibitory effects on the endothelial cell angiogenesis, metastasis, cell adhesion and MMP (matrix metalloprotease) activity.”

A “floxie” friend reported that he had been helped immensely by supplementing shark cartilage. (I honestly have really mixed feelings about suggesting that shark cartilage may be healing because I like sharks, but that’s beside the point, and I don’t want to withhold information from you because I feel uncomfortable about consuming shark byproducts.)

For those who (like me) aren’t comfortable supplementing shark cartilage, some other natural supplements that are MMP inhibitors include (source):

  • Soybean Seeds
  • Citrus Fruits
  • Berries
  • Curcumin
  • Green Tea
  • Black Tea
  • Grapes

Those things certainly fall into the “worth a try” category. Unfortunately, I haven’t heard of anyone having dramatically positive results from eating berries or grapes, but they probably won’t hurt you, and are likely worth trying.

It is also worth noting that tetracycline antibiotics including doxycycline (NOT a fluoroquinolone), are also MMP inhibitors. The article, Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells, notes how tetracycline antibiotics are bacteriostatic, not bactericidal, and how bacteriostatic antibiotics don’t cause the damage that bactericidal antibiotics inflict, and may even mitigate the damage caused by them. Low-dose doxycycline (or another tetracycline antibiotic) may help to inhibit MMPs and therefore mitigate damage and even promote healing. (Ask your doctor before starting this method.)

Though MMP activation is related to connective tissue breakdown, all fluoroquinolone toxicity symptoms, as well as cancer, arthritis, neuroinflammation, and more, to say that they are “bad” is overly simplistic. Everything in biology and health is complex and multifaceted. There are intricate feedback and feed-forward loops in many inputs. There are no easy or simple answers or cures.

With that said, MMP inhibitors may be helpful. Shark cartilage helped my friend, and it, or the other MMP inhibitors noted, may help you.

Though our bodies are complex, and there doesn’t seem to be a “magic bullet” that cures fluoroquinolone toxicity (or any other complex multi-symptom illness), there are things that can help push your body back to a state of health, and MMP inhibiting food and supplements are on that list.

 

 

 

Fluoroquinolone Toxicity Mimics Benzodiazepine Withdrawal – Beware

GABA “is the chief inhibitory neurotransmitter in the mammalian central nervous system. Its principal role is reducing neuronal excitability throughout the nervous system. In humans, GABA is also directly responsible for the regulation of muscle tone” (source). Fluoroquinolones “are known to non-competitively inhibit the activity of the neurotransmitter, GABA, thus decreasing the activation threshold needed for that neuron to generate an impulse.” (sourcesourcesource) Fluoroquinolones have also been shown to have similar effects on GABA neurotransmitters as benzodiazepine withdrawal (source).

The effects of fluoroquinolones on GABA-A neurotransmitters are the exact opposite of the effects of benzodiazepines, and, on a neurotransmitter level, they are the same as the effects of benzodiazepine withdrawal.

Symptoms of benzodiazepine withdrawal, AND fluoroquinolone toxicity, include:

  • sleep disturbances
  • irritability
  • increased tension and anxiety
  • panic attacks
  • tremors
  • difficulty with concentration
  • confusion and cognitive difficulty
  • memory problems
  • nausea
  • heart palpitations
  • headaches
  • muscular pain and stiffness
  • psychosis

And many other symptoms.

Both fluoroquinolone toxicity and benzodiazepine withdrawal are multi-symptom, chronic illnesses, for which there is no cure, and, despite significant research into both, the severity and complexity of both SYNDROMES is rarely acknowledged.

The following article does a brilliant job of connecting fluoroquinolone toxicity (syndrome) and benzodiazepine withdrawal (syndrome), and it gives a thorough explanation as to why people who have gone through benzodiazepine withdrawal should NEVER be prescribed fluoroquinolones. The article was originally published on the Benzodiazepine Information Coalition web site, www.benzoinfo.com, in October, 2016. It was written by Brad Verret, and I am grateful to him for the wonderful article.

Tragically, Brad Verret has passed away. I asked the editor of benzoinfo.com if I could re-publish it on floxiehope.com, and she said yes and noted that, “Brad wrote his articles to help as many people as possible. His intentions were to sound the alarm for benzodiazepine affected people to avoid that awful class of antibiotics, and he would have been pleased to help floxies avoid getting benzodiazepine injured.” She also noted that Brad was kind and smart and that he is missed dearly. I hope that his loved-ones see the use of his wonderful article as a tribute. Brad synthesized and interpreted the data about the effects of fluroquinolones and benzodiazepines on GABA-A thoughtfully and insightfully. This is a wonderful article, and Brad’s work is greatly appreciated! Please share it (or this entire post) far and wide – thank you!!

Hidden Dangers of Fluoroquinolone Antibiotics in the Benzodiazepine-Dependent Population

By Brad Verret

Whether it was for a sinus infection or bronchitis, most people have taken an antibiotic at some point in their lives. Antibiotics can be lifesaving medications but, like all other drugs, they come with risks. In particular, one specific class of antibiotic drugs called the fluoroquinolones carry serious risks that few people are aware of. In light of the growing epidemic of antibiotic resistance, each new generation of antibiotics has bolstered an enhanced degree of potency which can be viewed as both an asset and a liability. The fluoroquinolone class features a robust, broad-spectrum antibiotic effect and includes many popular drugs such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), moxifloxacin (Avelox), and gemifloxacin (Factive).

Chemically speaking, the mechanism of action of the fluoroquinolones closely mirrors that of certain chemotherapy drugs, so it is rather unsettling that these powerful agents are sometimes prescribed for relatively benign infections that would probably resolve on their own or with a milder drug. One notable and unique risk of the fluoroquinolones is that, unlike most other antibiotics, they are neurologically active at commonly prescribed dosages. As an action secondary to their primary antimicrobial effect, they are capable of binding to certain receptors in the brain, spinal cord, and peripheral nervous system. The primary receptor type affected is the GABA-A receptor, which is the exact same receptor that benzodiazepines act on.[1]

When a fluoroquinolone binds to a GABA receptor, the result is the polar opposite of the effect of CNS depressants like benzodiazepines. Fluoroquinolones are antagonists of the GABA-A receptor, meaning that they prevent the binding of GABA and can displace other molecules bound to the receptor, such as benzodiazepines.[1] GABA is an inhibitory neurotransmitter and drugs which enhance its action, like benzodiazepines, cause sedation. The GABA receptor blockade caused by a fluoroquinolone results in a CNS stimulant effect, with neurological manifestations ranging from mild insomnia and agitation to hallucinations and seizures.[2] Anyone can suffer these side effects, but individuals prescribed benzodiazepines are notably much more prone to experiencing these adverse neuropsychiatric reactions.

The culprit is the GABA receptor downregulation imposed by benzodiazepine tolerance. When a benzodiazepine is given chronically (beyond 10 days) there are a series of downward compensatory mechanisms which seek to restore a neurological equilibrium in light of the overstimulation of GABA receptors by the drug. This results in GABA receptors becoming progressively less receptive to GABA over time following prolonged exposure to benzodiazepines.[3] Over time, the brain’s GABA-dependent systems are weakened and there is a heightened vulnerability to external influences which decrease the action of GABA.

A storm neural excitation ensues when a fluoroquinolone “unmasks” the GABA receptor downregulation associated with benzodiazepine tolerance. In addition, since they share the same target, fluoroquinolones are capable of competing with benzodiazepines for GABA receptor binding in a concentration-dependent manner. Studies have shown a complex interaction when a fluoroquinolone and a benzodiazepine are simultaneously bound to a GABA receptor. At high concentrations, fluoroquinolones are capable of displacing a portion of the benzodiazepine molecules bound to GABA receptors.[4]This displacement can precipitate an acute benzodiazepine withdrawal syndrome which is identical to that which would normally happen if an individual were to suddenly reduce their benzodiazepine dosage.

Imagine each GABA receptor as having a gas pedal and a brake pedal. The entire GABA receptor, with its imaginary gas and brake pedals, is anchored into the neuron whose pace it controls. GABA agonists like benzodiazepines act on the brake pedal and GABA antagonists like fluoroquinolones act on the gas pedal. When an agonist acts on the brake pedal, chloride ions flow through the receptor into the neuron. Chloride ions are like an electrostatic glue which slows the neuron down. When an antagonist acts on the gas pedal, the flow of chloride stops and the neuron speeds up.

When an agonist is present for a prolonged period of time, the brake pedal gradually becomes worn out. Additionally, the neuron will recruit chemical messengers to tune up the gas pedal so that the neuron can continue to move along at its desired pace. It might be a pace that provokes anxiety, but it is the precise pace which will allow the neuron to fulfill its purpose within the unique neural circuit it belongs to. After being chronically slowed down by benzodiazepines, neurons want to break free but are held back by the presence of the drug. They will progressively fight back harder and harder to overcome this pharmacological oppression. Fluoroquinolones unleash neurons from their chemical bondage by disengaging the brake and stepping on the gas pedal, causing a sort of neural short-circuit as the freed neurons begin to race out of control.

It has been shown that certain non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen are capable of enhancing the GABA receptor blockade cause by fluoroquinolones, potentiating their neurotoxicity and exacerbating their CNS side effects.[5] NSAIDs are frequently co-prescribed with fluoroquinolone antibiotics for painful infections like sinusitis and urinary tract infections. Adding further insult to injury, some fluoroquinolones including ciprofloxacin (Cipro) are inhibitors of the CYP1A2 liver enzyme which is responsible for metabolizing caffeine and other xanthine alkaloids found in coffee, tea, and chocolate.[6] This commonly results in an increased sensitivity to the stimulating effects of caffeine when ciprofloxacin is taken. Hence, it is hardly a surprise that coffee drinkers who are prescribed a benzodiazepine are at an even higher risk for fluoroquinolone-induced seizures and neuropsychiatric disturbances.

It is an unfortunate truth that many healthcare practitioners outside the realm of neuroscience are unaware of these lesser-known facts about fluoroquinolone antibiotics. The fluoroquinolone-caffeine interaction is well documented but the fluoroquinolone-benzodiazepine interaction is not currently recognized in any of the current web-based drug interaction cross checking systems commonly used by healthcare consumers. Most pharmacists are not aware of the issue either, and will readily dispense fluoroquinolone prescriptions to benzodiazepine-dependent patients. This interaction is not consistently recognized yet it very consistently gets benzodiazepine-tolerant individuals into deep trouble. Studies have found that benzodiazepine-dependent individuals frequently experience depression, anxiety, psychosis, paranoia, severe insomnia, paraesthesia, tinnitus, hypersensitivity to light and sound, tremors, seizures, and suicidal thoughts upon exposure to fluoroquinolone antibiotics.[7] 

These symptoms are all consistent with acute benzodiazepine withdrawal syndrome. Furthermore, it may take several weeks or even months after discontinuing the fluoroquinolone for the affected individual to become symptom-free. This may be due to the long-term potentiation that occurs when excitatory glutamate-containing synapses are overstimulated by a deficit of GABA activity. Some individuals never return to their pre-fluoroquinolone state and they are commonly referred to as having been “floxed”. They are left with conditions including peripheral neuropathy, muscle weakness, cognitive dysfunction, new or worsened mental illness, and even paralysis which are all consistent with excitatory neurotoxicity (excitotoxicity) and brain damage.[8][9][10]

Taking all this into account, it is imperative that moving forward more healthcare professionals will become aware of and publicly acknowledge this dangerous interaction which has rendered normal, healthy people disabled. However, this alone is not enough. It is equally important that benzodiazepine-dependent individuals become aware of this interaction so that they can better advocate for themselves. It is well known that chronic benzodiazepine usage often creates chemical sensitivities which require the affected individuals to avoid a variety of foreign substances which most normal people can tolerate, and fluoroquinolones probably fall at the very top of that list.

All doctors should be aware that prescribing a fluoroquinolone to a benzodiazepine-dependent individual carries a serious risk for disability which could potentially be permanent. Fluoroquinolones should be contraindicated with chronic benzodiazepine exposure in nearly every scenario, including nonmedical benzodiazepine abuse. Clinicians should explore all alternatives before fluoroquinolones are considered. In rare cases where it has been determined that failing to administer a fluoroquinolone could result in death, benzodiazepine-dependent individuals should have their benzodiazepine dosages increased for the entire duration of fluoroquinolone therapy and until the drug is completely cleared from their system.

 

 

Fluoroquinolone Toxicity Article – Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications

I’m so excited to share this article, “Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications” by Krzysztof Michalak, Aleksandra Sobolewska-Wlodarczyk, Marcin Włodarczyk, Justyna Sobolewska, Piotr Woźniak, and Bogusław Sobolewski, with you! It is the first article of its kind that I’ve seen. While there are thousands of articles about fluoroquinolones, many of which focus on the damaging effects of fluoroquinolones, and many case-studies that note the adverse-effects of fluoroquinolones (hundreds of articles about fluoroquinolones are linked HERE), this is the first article that acknowledges that fluoroquinolone toxicity (referred to as both Fluoroquinolone Associated Disability (FQAD) and fluoroquinolone toxicity throughout the article) is a disabling syndrome, that also goes over the mechanisms by which fluoroquinolones can cause fluoroquinolone toxicity/FQAD, and even gives recommendations on how to treat fluoroquinolone toxicity/FQAD (while also acknowledging that there are no cures or verified treatments). The article even calls for more extensive research to be done into fluoroquinolone toxicity, and the various mechanisms through which fluoroquinolones hurt people.

It is an enlightening article, and I encourage you to print it out and give it to your doctors, family members, and anyone else who is interested in what fluoroquinolones do and how they hurt people. In this post, I’m going to go over some highlights from the article, but I recommend that you read it yourself (you can access it through THIS LINK, after clicking on the “provisional pdf” link).

The first paragraph of the abstract to the article states:

“Long term Fluoroquinolone Associated Disability (FQAD) after fluoroquinolone (FQ) antibiotic therapy appears in recent years a significant medical and social problem, because patients suffer for many years after prescribed antimicrobial FQ-treatment from tiredness, concentration problems, neuropathies, tendinopathies and other symptoms. The knowledge about the molecular activity of FQs in the cells remains unclear in many details. The effective treatment of this chronic state remains difficult and not effective. The current paper reviews the pathobiochemical properties of FQs, hints the directions for further research and reviews the research concerning the proposed treatment of patients.”

To see that in writing, in an academic article, is incredibly validating.

Adverse Effects of Fluoroquinolones

Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications, goes over the documented effects of fluoroquinolones. For tendinopathies and tendon ruptures, researchers have found that:

“FQs are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy.”

Fluoroquinolones cause neurotoxicity, as well as central and peripheral nervous system ailments:

“Taking FQs is associated with their neurotoxicity, as well [5-8]. The main symptoms being correlated to FQ treatment include insomnia, restlessness, and rarely, seizure, convulsions, and psychosis [9-11]. Many reports point to chronic persistent peripheral neuropathy to be generated by FQs [12-18]. Cohen et al. [19] showed that a possible association between FQ and severe, long-term adverse effects involving the peripheral nervous system as well as other organ systems are observed.

Fluoroquinolones also cause cardiotoxicity and an elongation of the QT interval, as well as hepatotoxicity and nephrotoxicity. Fluoroquinolone use has even been linked to type-2 diabetes onset.

Fluoroquinolone toxicity / FQAD is a multi-symptom, chronic illness that affects all body systems. Fluoroquinolones deleteriously affect every muscle, tendon, ligament, nerve, and even bone, in the body. They damage every cell in the body.

Fluoroquinolone Damage Mechanisms

Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications, notes the various mechanisms by which fluoroquinolones cause cellular (mitochondrial) damage, including oxidative stress, and the downstream effects of oxidative stress, including disruptions in the mitochondrial Permeability Transition Pore (PTP) (and the article authors state, “The influence of FQs on the detailed regulation of PTP is the urgent topic for further research.”), Calcium and magnesium homeostasis, lowered ATP production, and more.

Here is a diagram of the mechanisms of fluoroquinolone toxicity (published in the article):

Figure 2. The main ways of FQ toxicity. The positive regulatory loops magnifying the toxicity of FQs are marked with ‘+’. The ‘?’ signs denote the possible but not confirmed effects of FQ toxicity.

The article also notes the epigenetic effects of fluoroquinolones and oxidative stress:

“Beside OS (oxidative stress), epigenetic effects of FQs are of high importance, as well. The epigenetic effects may depend on the methylation of DNA and/or histones, however, ROS contribute also to epigenetic changes [42]. Some authors point also to the similarity of bacterial and mitochondrial DNA, both existing in circular super-twisted helices and gyrase-like enzymes being postulated to be responsible for the organization of mitochondrial DNA, suggesting the possible direct effect of FQs to mitochondrial DNA leading to the disturbed mitochondria regeneration and division [43, 44]. The changes in the cytoskeleton were observed also after FQ treatment [45] and cytoskeleton has been demonstrated to be strictly connected with energy dissipation and organization in mitochondria [46-49].”

Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications, also notes that fluoroquinolones chelate various minerals and metals. The article notes that, “Seedher’s results indicate that chelation formation with bivalent metals can cause significant alterations in the human serum-FQ binding affinity.” The article also describes how fluoroquinolones chelate iron, zinc, magnesium, and other minerals, and how this chelation can have enzymatic and even epigenetic adverse effects.

Fluoroquinolones are GABA antagonists, and the effects of fluoroquinolones are similar to those of benzodiazepine withdrawal. The authors of Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications, describe a potential mechanism through which GABA is depleted by fluoroquinolones:

“One of the proteins which can support PTP opening is Translator Protein (TSPO), called also peripheral-type benzodiazepine receptor or isoquinoline binding protein. TSPO is predominantly located on the surface of the mitochondria where it is postulated to physically associate with VDAC-ANT. It has been suggested that TSPO may activate PTP opening, causing ∆Ψm reduction and leading to apoptosis [80, 81]. Some authors suggest that epileptogenic activity of FQs possibly relates to GABA-like structure of some FQs which may allow them to act as GABA antagonists [82, 83]. Since TSPO is also a benzodiazepine receptor, similar interaction may maybe also take place between FQs and TSPO leading to opening PTP.”

I have always wondered how GABA inhibition is connected to mitochondrial destruction. The article excerpt above answers that question for me.

Fluoroquinolones can lead to chronic illness and permanent disability, which has led many people to question whether or not they remain in the body for an extended period of time (or, if they do damage while they’re in the body that continues long after the drug has left the body). The authors of Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications note that:

“The other important feature of FQs has been presented by V.T. Andrioleet al. [55]. Namely, they estimated the minimum solubility of FQs in neutral pH. They pointed that this class of molecules is characterized by very high melting point, generally >200°C, which indicates that the crystal forms are very stable. All these FQ features strongly support the thesis that FQs can survive in the cell for a long time contributing to chronic, long-term adverse reaction in patients treated with FQs. The question, to what extent takes this phenomenon place and if it contributes to chronic symptoms of FQAD, remains unclear.”

It is acknowledged throughout the article that it is unknown whether or not fluoroquinolones stay in the body for an extended period of time. It is possible, through the mechanism noted above, but no hypotheses about fluoroquinolones remaining in the body after they “should” have been metabolized and fully excreted, have been explored. It’s both possible that they remain in cells, and that they don’t – no one really knows.

The article authors repeatedly call for additional research into the various mechanisms by which fluoroquinolones lead to pain, disability, and chronic illness:

“Summing up, the number of enzymes possessing reduced activity due to their ion-cofactor chelation is probably long and it is the important topic for further research. The separate problem consists the chronicity of ion-chelation by FQs. The presented research does not describe the chronic state of FQAD but the phenomena taking place during FQ application. It must be analyzed, to which degree persistent ion chelation takes place at FQAD patients.”

Fluoroquinolone Toxicity Treatment

Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications is the first article I’ve seen that discusses the treatment of fluoroquinolone toxicity as a multi-symptom, chronic illness. The authors note that the first step in approaching a treatment is to discover why fluoroquinolones are causing chronic illness in the first place. Effective treatment, of course, depends on effective identification of the problem. With that noted, the article authors have enough knowledge to make a few suggestions:

“Until detailed knowledge concerning FQ toxicity would be recognized, the following directions in supporting FQAD patients are proposed according to the known and probable mechanisms of FQ toxicity: A. reduction of the oxidative stress; B. restoring reduced mitochondrial potential ∆Ψm; C. supplementation of uni- and bivalent cations that are chelated by FQs;D. supporting the mitochondrial replication in the cell – pulling the more destroyed to apoptosis and proliferation of the more healthy ones; E. removing FQs permanently accumulated in the cells (if this phenomenon takes place); F. regulating the disturbed epigenetics and enzyme activities”

The article authors note that antioxidant supplementation is a broad topic and that fixing the damage done by fluoroquinolones and oxidative stress is not as simple as just ingesting an antioxidant pill. However, antioxidant supplements that specifically target the mitochondria have shown some promising results:

“The antioxidants which enter easily the mitochondria are the most interesting ones. Lowes et al. [79] shows that the mitochondria targeted antioxidant MitoQ protects against fluoroquinolone-induced oxidative stress and mitochondrial membrane damage in human Achilles tendon cells. In cells treated with MitoQ the oxidative stress was lower and mitochondrial membrane potential was maintained.”

Other antioxidants have also had promising results in repairing fluoroquinolone treated cells. Some of the antioxidants with promising results include N-acetylcysteine, resveratrol, as well as Vitamins C and E. Supplementation of the trace minerals that are important cofactors for antioxidants is also important.

Conclusion

I greatly appreciate the authors of Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications. They approach fluoroquinolone toxicity/FQAD as a complex and multifaceted illness. It IS a complex and multifaceted illness, and it is refreshing to read an article that doesn’t over-simplify or downplay the illness. I also appreciate the exploration of what is currently known about fluoroquinolone toxicity/FQAD, and the assertions that more research into fluoroquinolone toxicity is needed (it is!). I think that everyone who is going through fluoroquinolone toxicity/FQAD should read it, and share it as widely as possible.

 

 

 

Floxie Hope Podcast Episode 23 – Tara

Tara shared her journey through Levaquin-induced fluoroquinolone toxicity in Episode 23 of The Floxie Hope Podcast. Please check it out!

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

You can also read more about Tara’s journey in her story:

https://floxiehope.com/taras-story-healing-from-levaquin-effects/

Tara has noted several times that she was not as far along in her journey as she thought she was when she wrote her story. Please listen to the podcast for more information about Tara’s journey. It is not a repeat of her story above.

Also, here is a different podcast that she did with her doctor:

https://floxiehope.com/2016/03/12/true-health-made-simple-podcast-featuring-tara/

Tara gives a wealth of information about her journey, and how complete avoidance of fluoride, along with various homeopathic methods, supplements, and other things, have helped her through the last two years.

Also, here are some notes and resources from Tara to accompany the information she gives in the podcast:

“What I’m told by fluoride experts is that it matters how much fluoride was already accumulated in your system if you get fluoride poisoned or if you are already sensitive to it by genetics or be because of other chemicals or stressors. Also, whether or not a person becomes hypersensitive does not seem to correlate with how badly they are injured. Ex: People who are hurt much worse than me, still may not become hypersensitive. The spectrum of sensitivity may not have anything to do with the amount of injury from what I can tell through research or peoples’ stories.”

“Also, Im not sure if I was clear about the Fluoride Poisoning symptoms – a person does not usually “feel” anything after ingesting fluoride or coming in contact with fluoride – only a hypersensitive person like myself, which is rare -most people who are poisoned because of fluoride just develop symptoms/diseases/disorders due to the enzymes, tissues, and structures that are poisoned. Most people discover they are poisoned from fluoride by getting completely off of it and symptoms get better (damage has to be repaired over time, some damage is not repairable for all people – but there is always hope of better).”

“Coffee – I forgot to mention this most important topic! 🙂 I was not able to drink anything caffeinated – not even a sip – for 20 months – using the SCIO to heal neurotransmitters (Adenosine is neurotransmitter associated with caffeine receptor site – also used SCIO to heal neurotransmitters in general helped immensely, to heal nerves, healing mitochondria DNA, food allergies, and attempting to desensitize from fluoride).

I am more than happy to report I can now drink a small cup of Bulletproof coffee (free of mold), and put Brain Octane (distilled coconut oil  – helps mitochondria for brain energy), butter (also good for brain), and when my fluoride is low enough, I can handle also putting in the Collagelatin powder in the coffee (good way to replace collagen and gelatin) for me. This is all mixed in a food processor together to combine – according to his book, there is a scientific reason why stirring doesn’t have same effects so needs to be blended.  I really like the taste and that it’s mold free. The founder of Bulletproof used to have Chronic Fatigue Syndrome, mold allergies, I think also Lyme, etc – so his story is good to read for inspiration – it brought him to a lot of research on mitochondria and health and building this very successful company.
bulletproof.com
(This is also the coffee I use for coffee enemas – it does matter that the coffee is pesticide and toxin free as possible – helped with small intestinal bacteria overgrowth SIBO)”

Resources:

Homeopathy – company name White Dove – Vitamin C, Bone Support, Pitui Liquitrophic, Fem Liquitrophic (I get these from my chiropractor’s office)
Solutions 4 supplements (chiropractor’s office)
MitoQ – mitoq.com
Pelican brimac bone char filtration system to remove fluoride – https://www.pelicanwater.com/whole-house-fluoride-filters
Allerphase (allergy/asthma herbal supplement – https://www.tangoherbs.com/allerphase60.html (side note: My son, 10-years-old, was able to get off his allergy and asthma medications – he has been on them since age 3, with the addition of Allerphase and MSM (from mercola.com), as well as getting off dairy/gluten and switching to an organic diet)
Harmless Harvest Coconut Water from Whole Foods (all coconut water is not made equal – some are highly processed – good idea to do some research – this is the one I use)
Infrared sauna – http://www.sunlighten.com/
Hyperbaric Oxygen Chamber Treatment – http://www.oxygenunderpressure.com/ – This is the HBOT Institute I went to – it’s a stand alone chamber by the Kansas City, MO airport – people from all over the United States come here for treatment – sessions were $125-$175 per session, 40 sessions is what was recommended. Expensive but worth getting my brain back.
Books:
Diagnosis and Treatment of Chronic Fatigue Syndrome and Myalgic Encephalitis by Dr Sarah Myhill
Eat Dirt by Dr. Josh Axe –
The Thyroid Connection by Dr. Amy Myers
The Wahl’s Protocol by Dr. Terry Wahls
The Devil’s Poison: How Fluoride is Killing You by Dean Murphy, DDS
Letting Go by Dr. David Hawkins
The Fluoride Toxicity Research Collaborative – http://www.slweb.org/ftrcfluoroquinolone.html
The Truth About Water Fluoridation by Charles Eliot Perkins (1952)
SpectraCell test – for minerals/vitamins/antioxidants/etc – also get test for iron and copper
Dr. David Gulledge, chiropractor for homeopathy, SCIO
Supplements suggested by the Fluoride Toxicity Research Collaborative (FTRC) for fluoride/fluoroquinolone toxicity (they lab tested to find good/cheap brands):
Calcium – solutions 4 brand or FTRC said Standard Process (can get from a chiropractor or naturopath) – fluoride binds to calcium and leaves the body in large quantities
Vitamin C with flavanoids- detoxes fluoride – they said Trader Joes brand with the lemon flavanoids. I do better with homeopath Vitamin C.
B-vitamins – fluoride disrupts synthesis of B-vitamins – (FTRC said Trader Joes brand)
Magnesium – fluoride chelates this mineral as well (FTRC said Kal brand – found at whole foods is good). I use Epsom Salt. If I wasn’t as sensitive to fluoride, I would choose Ancient Minerals magnesium lotion – loved it.
This article was sent to me by my chiropractor- it’s is by Dr. Jack Kruse – about being floxed and what to do about it – good information on staying away from EMFs, fluoride, etc. (I am very sensitive to EMFs since being floxed/fluoride poisoned)
Blue-blocking glasses I use to watch TV, look at my phone or computer – needed since being fluoride poisoned
Thank you for listening!

 

Fluoroquinolone Antibiotics Increase Risk of Birth Defects

A few years ago, a friend from high school who was in her second trimester of pregnancy with her second child, reached out to me to ask me what antibiotics she should avoid. She had pneumonia, and was on her way to the doctor’s office. I told her that she should steer clear fluoroquinolones (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin).

Being an empowered and skeptical person, my friend didn’t just take my word for it that fluoroquinolones were dangerous, she did her own research and noted that the warning label for Cipro/ciprofloxacin stated:

Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. CIPRO should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother. An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System–concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk.2

With that information in-hand, she was empowered to adamantly refuse the prescription for Cipro that her doctor wanted to give her, and instead insisted that she get a prescription for a safer antibiotic (a pregnancy category B antibiotic).

I was relieved beyond words when she told me that she had refused the Cipro prescription. She wasn’t going to get floxed, and whatever effects the Cipro may have had on her baby were avoided.

Study Indicates that Fluoroquinolones May Increase Risk of Birth Defects

A recent study in the British Journal of Pharmacology, “Use of antibiotics during pregnancy and the risk of major congenital malformations: a population based cohort study” has shown that, “antibiotics in the class called quinolones — ciprofloxacin, levofloxacin and others — are particularly dangerous and should be avoided in pregnancy.”

The study, which “followed 139,938 mothers of babies born in Quebec from 1998 to 2008, tracking their antibiotic use in the first trimester, and their babies’ birth defects through the first year of life” found that:

Moxifloxacin exposure was associated with a 5-fold increased risk of respiratory system malformations and ofloxacin use with an 8-fold increased risk of MCMs. However, these results should be interpreted with caution given the small number of exposed cases.

Teratogenicity of quinolone has been reported in the literature in animal and experimental studies [50, 51]. Indeed, quinolones can act as DNA gyrase inhibitors and also as mitotic inhibitors [52]. This may partially damage DNA and induce fetal malformation, which supports our findings [52].

The other antibiotics examined were also more dangerous during pregnancy than I think any pregnant woman should feel comfortable with, but fluoroquinolones were found to be particularly dangerous.

Too Many Pregnant Women are Prescribed Fluoroquinolone Antibiotics

My friend had a healthy son, and he is now a happy and healthy toddler. She took antibiotics (but not fluoroquinolone antibiotics) during pregnancy, but her son was not negatively affected.

My friend was fortunate. However, most pregnant women don’t have a high school friend who incessantly posts about the dangers of fluoroquinolones, and many of them take fluoroquinolones during pregnancy without being aware of the risks these drugs pose to them or their babies. Doctors who prescribe fluoroquinolones to pregnant women, when there are safer alternative antibiotics, are endangering women and children, and there is nothing okay about that.

***

New York Times, “Certain Antibiotics May Increase Risk of Birth Defects

British Journal of Clinical Pharmacology, “Use of antibiotics during pregnancy and the risk of major congenital malformations: a population based cohort study

***

 

 

Floxie Hope Podcast Episode 22 – Michelle

Michelle skiing post-flox and post-healing

Michelle shared her story of fluoroquinolone toxicity, and her healing journey, in episode 22 of The Floxie Hope Podcast. You can listen to it here:

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Please consider subscribing to The Floxie Hope Podcast through iTunes or whatever podcast app you use. Thanks!

You can also read about her journey on her web site, https://barefootaya.com/. Here are her posts specifically about fluoroquinolone toxicity and her journey through “mysterious illness.”

The Mystery Illness: Part 1, Symptoms

The Mystery Illness: Part 2, Finding "The Cure"

The Mystery Illness: Part 3, Healing

How to Take Antibiotics

Here are some things that helped her, that she mentions in the podcast:

Genova’s Organix Comprehensive Profile test (the mitochondria urine test)

Michelle is incredibly insightful, thoughtful, and entertaining in her episode of The Floxie Hope Podcast. Please check it out!
Thank you for sharing your journey with us, Michelle!

Books by Floxies

There are a couple of new books available on Amazon about dealing with, and making it through, fluoroquinolone toxicity. Both of the following books are written by “floxed” women, and both generously share a message of hope, perseverance, and strength through the difficult and painful journey of fluoroquinolone toxicity.

Praying Through Pliés: Living With Lupus and Surviving An Antibiotic Called Levaquin

Praying Through Pliés: Living With Lupus and Surviving An Antibiotic Called Levaquin by Rhonda “Jean” Bolton is described as follows:

“A nurse’s true and inspiring journey of living with lupus and later surviving a devastating reaction to the fluoroquinolone antibiotic, Levaquin, by weaving her faith and her love for ballet into a powerful story of transformation. Beautifully and poignantly written, the author addresses her personal loss, grief, sadness, and anger, but the prevailing message is one of hope, love, and gratitude. Included are sections on exercise, sleep, stress management, and nutrition with simple and realistic suggestions for change. This book has the potential to bring healing, hope, and joy to those dealing with chronic illness, loss, or challenges of any kind, but it is also is for anyone who desires to make positive changes in his or her life. Also written for those who suffer from adverse reactions to fluoroquinolone antibiotics and who are unheard or even discounted, this story provides support and encouragement, while adding one more voice of credibility to their pain and disabilities.”

In an email correspondence, Jean also noted that, “Early readers have said it is a powerful and inspiring story of healing and transformation. I combine faith and my love for ballet to offer others what I have learned about lifestyle changes in the areas of stress management, nutrition, sleep, stress management, and exercise, the importance of positive thinking, and the power of gratitude. My hope is that this book will bring hope and healing to others.”

Thank you so much for writing about your journey through fluoroquinolone toxicity (on top of autoimmune diseases) and for sharing it with the “floxies” of the world, Jean!

The Magnificent Story Of A Lame Author

The second highlighted new book about a woman’s journey through fluoroquinolone toxicity is The Magnificent Story Of A Lame Author by Amy Moser.

The author, Amy Moser, is also the author of the viral blog post, “This Antibiotic will Ruin You.” “This Antibiotic will Ruin You” was viewed and read MILLIONS of times, and greatly increased awareness of the dangers of fluoroquinolone antibiotics.

Amy followed up”This Antibiotic will Ruin You” withThe Magnificent Story Of A Lame Author. The Amazon description of the book states:

“When I was growing up, I pictured myself as a nurse, an olympian, an astronaut…but never handicapped. I just didn’t see that coming. I was as happy and enthusiastic to greet this new challenge, as I would be a swarm of bees. It can be very hard to accept great trial with open arms.
I might be lame, but my story isn’t. Nearly seven years ago at the age of 28, my body suddenly disintegrated underneath me. My doctors had no idea why my previously healthy body was imploding. I was a spunky young wife and mother stunned by her new circumstances. Discovering the cause offered no cure. What now? Where do I go from here?
When I’m overwhelmed by this burden, and I’m too heavy to forge ahead, the hand of God lifts me and leads me on. My journey is incredibly hard, but immeasurably blessed by God. Impossible situations give God opportunity to shine and us an opportunity to trust. Miracles wouldn’t be miracles if they were possible. You know the phrase, “When life gives you lemons…make lemonade.” I’ll give you a new one. When life throws you dung, use it as fertilizer to grow your mustard seed of faith. It may move a mountain or grant you the strength to traverse over it.
This story is about building an unconditional faith in God even during the most grueling moments of my life. I’m finding beauty and hope along a rugged path I never would have chosen for myself.”

An Amazon review of the book, from Roland, stated:

“Amy Moser has endured more pain and suffering than anyone should ever have and all because of one medication for a mild infection. Her heart for God and her iron clad faith in His goodness and mercy have kept her going for her devoted husband and her children. I have never read a stronger testimony about the power of prayer and an unwavering faith. This is a very important book because of the warning about Cipro and the other drugs in its category and how catastrophic the side effects can be. But more importantly, seeing her faith as she describes dealing with the truly awful things happening to her formerly healthy body is a gift to us all. Read this book. Learn more about the side effects of these dangerous drugs. They are horrifying. Then say a prayer for Amy Moser and all the others suffering because of these drugs.”

Both books are generously and thoughtfully written. They describe journeys of hope and faith, and they are gifts to those who read them. I hope that they help you through your journey through fluoroquinolone toxicity as well!

 

Are you going to heal?

People often ask me if they are going to recover from fluoroquinolone toxicity. I struggle to answer them.

The most truthful and honest answer I can give is, “I don’t know.” I truly don’t. I don’t know how anyone else’s body is going to react to this poison. I don’t know if you’re going to get worse or better. I don’t know what your timeline will be. I don’t know if you’ll go through cycles. I don’t know if you’ve hit the worst of what is going to happen and your journey is all uphill from here, or if your pain and suffering have just begun.

Fluoroquinolone toxicity is so strange and individualized. There are some people who are permanently disabled by one pill, while there are others who tolerate multiple prescriptions of fluoroquinolones with no notable effect, but with their hundredth pill a “bomb” goes off in their body. Some reactions are sudden and easily noticeable, while other people have a gradual accumulation of damage and they slowly notice that they have insomnia, anxiety, GI distress, and that they cannot tolerate foods or chemicals like they used to – those people are floxed, but they often think that they’re “just getting old.” There are some people who have delayed reactions, there are some people who have immediate reactions. Reactions range in severity from mild to severe.

Different things help different people. Some people are helped by supplements, IVs, acupuncture, chiropractic, physical therapy, special diets, etc. But other people aren’t helped by those things, and some people are even hurt by them.

Everyone is different. I don’t know whether or not you will recover. I wish I did so I could give a better answer than, “I don’t know.” I can tell you that I have recovered. I recovered fully. I can work, hike, bike, travel, sleep, eat, and function as I did before I took ciprofloxacin. Probably because of my perspective as a person who has fully recovered, I tend to believe that many, maybe most, people can recover. People send me their recovery stories, and there are many more people who I see post things about their recovery on facebook. I see people move on with their lives. It’s hard to tell from facebook posts whether or not people are healed – you can’t see pain – but you can see that people are continuing to live life and that their pain and illness don’t consume every aspect of who they are. I see healing. I know that it can happen.

I also know that not everyone recovers. It needs to be acknowledged that some people are PERMANENTLY injured by Cipro, Levaquin, Avelox, Floxin, and the generic fluoroquinolones. Some of those people are permanently disabled because of muscle wasting and tendon tears, some of them struggle with chronic and permanent pain, some develop autoimmune diseases for which there is no cure, some never gain their energy back, some have insomnia that negatively affects every aspect of their life, some have serious psychiatric issues, some people have intractable GI issues and food intolerances, etc. The people who are severely floxed, who are not going to recover, deserve acknowledgement and respect for their struggles. Severely floxed people are some of the strongest people I know. During a conversation with friend of mine who was SEVERELY floxed (she was bedbound and paralyzed for months, and it hurt for her to blink) I noted that if she had been floxed at the level that I was (a moderate reaction) she would still be running, but if I was floxed at the level that she was, I’d be dead. She is so, so, so, so strong, and she has my undying respect and admiration.

When people ask me if they are going to be okay, if they are going to recover and heal, I think that they’re often looking for reassurance. On some level, they must know that I don’t actually know whether or not they’re going to heal (I’m just a fellow floxie who happens to write on the internet), but they want to hear someone who has been through it say, “You’re going to be okay. You will heal. It will get better.” I often say that to people. I believe it too. I think that it’s true for many, maybe most, people. Our bodies really do have amazing healing abilities. There are people who are floxed at all levels who see changes in their condition, and even healing. (My friend mentioned above has made remarkable progress. She may never recover to the point where she can run again, but she is no longer bed-bound.) Health ebbs and flows. Our bodies are constantly healing, and aging, and going through good times and bad. Most importantly, I think that hope is important, and that it’s healing. Reassuring people, and telling them that they’re going to be okay, gives them hope. Telling them that I have recovered gives them hope that they too will recover. Telling them that recovery is possible helps them to get through the hard times.

Hope is really, really, important.

Acknowledging that these drugs can do permanent damage, and giving respect to the permanently injured people who are living with the damage, is important too.

I try to walk the line between giving hope and acknowledging the pain that these drugs cause. I do my best, but I’m not always successful. I believe that it is the right thing to do to reassure people when they are scared, and to give them hope when possible. I also believe that it is the right thing to do to tell the truth (that I don’t know). Sometimes those things aren’t reconcilable.

Perhaps the best answer to the question of, “Will I be okay?” is, “I don’t know, but I can tell you that I fully recovered, so I know that it’s possible.” That’s the truth. And I hope that my recovery gives all who hear about it hope that they too will recover. Hope really is important and healing. It’s vital, and I hope that I can give you hope while still acknowledging that I don’t know what the future holds for myself or anyone else.

 

 

Do Fluoroquinolones Cause Cerebrospinal Fluid Leaks?

It is well known that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others) damage connective tissues–including musculoskeletal connective tissues like tendons, cartilage, bone, and muscle, as well as other connective tissues such as ocular tissue (including the retina), eardrums, and cardiac/heart tissue. Multiple studies have found that fluoroquinolones are toxic and damaging to connective tissues. Given the wide differences in tissues that fluoroquinolones have been shown to deleteriously affect–from cartilage to cardiac/heart tissue–it is reasonable to assert that they damage all connective tissues throughout the body. (Read any of the articles in the citations listed below for information about how fluoroquinolones damage connective tissues.)

Given that fluoroquinolones damage connective tissues (probably all connective tissues), I have a new, developing, hypothesis for how fluoroquinolones lead to fluoroquinolone toxicity syndrome/fluoroquinolone associated disability (FQAD). Please keep in mind that this is one of many hypotheses, and it is just one among about a dozen possibilities (you can read about some of the other possibilities on the post What is Fluoroquinolone Toxicity, or through the free ebook Hacking Fluoroquinolones.)

Hypothesis:

Fluoroquinolones damage the dura (dura mater)–the layer of connective tissue that surrounds the brain and spinal cord and keeps spinal fluid around those vital organs. This leads to spinal fluid leakage, which leads to many symptoms of fluoroquinolone toxicity, including:

  • Headaches (Including chronic migraines)
  • Autonomic nervous system dysfunction including POTS (postural orthostatic tachycardia syndrome) symptoms
  • Nausea and/or vomiting
  • Ringing in the ears (tinnitus) and hearing changes
  • Neck pain and stiffness
  • Radicular pain
  • Memory and cognitive problems (and other “neurolgic weirdness”)
  • Fatigue
  • Tachycardia (Racing heart/heart palpitations)
  • Dizziness (especially upon standing)

This wonderful lecture by Dr. Ian Carroll describes how cerebrospinal fluid leaks can lead to symptoms of many illnesses, including “mysterious” diseases like POTS, ME/CFS, fibromyalgia, as well as heart palpitations and severe headaches.

I suggest that you watch the entire video, as well as Dr. Carroll’s other videos on youtube. Here are some notes/highlights from the video above:

  • Many symptoms of POTS are actually cerebrospinal fluid leaks
  • The spinal cord is surrounded by tissue called the dura, and the dura holds cerebrospinal fluid around the spinal cord and brain. It’s like a water-tight bag that holds in cerebrospinal fluid and maintains pressure.
  • What causes people to have cerebrospinal fluid leaks?
    • Messed up connective tissue
      • From connective tissue disorders like ehlers danlos syndrome
      • (From fluoroquinolones???)
    • Something calcified and boney sticking into the dura
      • Bulging discs
    • Iatrogenic damage
      • Lumbar punctures
      • Epidurals
      • Back surgery
    • Car accidents (and other types of jarring, high-speed accidents)
      • Whiplash
  • How do you know if you have messed up connective tissue?
  • Calcium spikes sticking into the dura are difficult to detect via MRI, but they are clearer with a ct myelogram.
  • “Neurologic weirdness” is a sign of cerebrospinal fluid leaks. If someone is more confused later in the day, that can be an example of neurologic weirdness that results from a leak.
  • Cerebrospinal fluid leaks are misunderstood and under-recognized.
    • Post-puncture cerebrospinal fluid leaks are recognized.
    • Longer term cerebrospinal fluid leaks are less recognized and they present differently.
  • Post Dural Puncture Headache (PDPH) vs. Spontaneous Leak
    • Post Dural Puncture Headache (PDPH)
      • Single leak, orthostatic headache, 90% response to single EBP, Natural history understood and mostly benign, rarely mysterious, young women most at risk, fixable.
    • Spontaneous Leak
      • 30-40% multisite leak, late day headache, exertional headache, non-orthostatic CDH, 30% response to single EBP, natural history poorly understood and marked by chronic disability, often mysterious, HDCT, fixable.
  • There are people out there who have cerebrospinal fluid leaks that aren’t being recognized. Many people with cerebrospinal fluid leaks are misdiagnosed. Cerebrospinal fluid leaks are fixable and it is a shame that they aren’t all being recognized.
    • Cerebrospinal fluid leaks are NOT RARE.
  • Symptoms of cerebrospinal fluid leaks:
    • Headache, nausea and/or vomiting, ringing in the ears and hearing changes, neck pain and stiffness, radicular pain, neurological weirdness, fatigue
  • The effects of cerebrospinal fluid leaks on the pituitary gland
    • The pituitary gland is enlarged (How does this affect hormones???)
    • The connection between the pituitary gland and the brain can be disturbed, and this can lead to hormonal disruptions. High prolactin is an indicator of this problem.
  • Cerebrospinal fluid leaks can cause sagging of other parts of the brain.
  • MRIs of people suffering from cerebrospinal fluid leaks often appear normal. They are subtle and most doctors aren’t trained to see them.
  • Treatment of cerebrospinal fluid leaks
    • Epidural blood patches (Dr. Carroll describes how they’re done)
  • Cerebrospinal fluid leaks are NOT RARE, they’re just misdiagnosed and under-recognized

Before I watched Dr. Carroll’s lecture, I knew that cerebrospinal fluid leaks were painful and debilitating, but I didn’t realize that they were connected to “mysterious” disease symptoms or autonomic nervous system damage.

Connecting cerebrospinal fluid leaks to fatigue, a racing heart, blood pressure and blood sugar irregularities, tinnitus, cognitive and memory problems, hormonal abnormalities, etc. establishes a plausible connection between the (well-established) connective tissue damage done by fluoroquinolones, and the array of chronic, mysterious, disease symptoms that people with fluoroquinolone toxicity suffer from. Perhaps fluoroquinolones cause an array of debilitating chronic, mysterious illness symptoms through damaging the dura and allowing cerebrospinal fluid to leak–which leads to multiple symptoms of fluoroquinolone toxicity (and other chronic illnesses). It certainly seems like a plausible hypothesis to me. It actually seems like an easier hypothesis to postulate and prove than many of the other hypotheses regarding fluoroquinolone toxicity that have been put forth. As I noted above, the damage that fluoroquinolones do to connective tissues is well-established and recognized, and if someone looked at the effects of fluoroquinolones on dura mater tissue specifically, this hypothesis would be easily testable.

Some additional evidence supporting the possible connection between fluoroquinolones and cerebrospinal fluid leaks comes from the large number of people in cerebrospinal fluid leak support groups that have taken fluoroquinolones in the past who assert that fluoroquinolones contributed to their cerebrospinal fluid leak. I know that asking people in facebook support groups doesn’t count as a scientific study, but (to the best of my knowledge) no scientific studies of the link between fluoroquinolone use and cerebrospinal fluid leaks has been done, and the testimonials of the people who have cerebrospinal fluid leaks are important–they point both researchers and fellow patients toward research that may provide answers.

I also find it to be interesting that cerebrospinal fluid leaks affect the pituitary gland, which affects hormone production and regulation. Many people with fluoroquinolone toxicity syndrome have hormonal problems–from tanked testosterone to thyroid abnormalities. Maybe fluoroquinolones cause damaged dura tissue, which causes cerebrospinal fluid leaks, which causes pituitary gland structural abnormalities, which causes hormonal dysregulation, which causes multi-symptom chronic illness symptoms.

Dr. Carroll’s hypotheses and observations are fascinating and exciting for those who are dealing with fluoroquinolone toxicity and other multi-symptom, chronic, mysterious illnesses. I hope that they are explored further. Dr. Carroll’s results with patients are incredibly promising, exciting, and hopeful for people who are suffering from multi-symptom, chronic, mysterious illnesses–including those suffering from fluoroquinolone toxicity. I hope that Dr. Carroll, or other clinicians or researchers, look into the connections between fluoroquinolones and chronic cerebrospinal fluid leaks. It’s possible that the connections could lead to a comprehensive theory of fluoroquinolone toxicity, and may also lead to breakthroughs in other chronic illnesses.

Citations:

Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population. Hall, Mederic M. et al. PM&R , Volume 3 , Issue 2 , 132 – 142

Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral Fluoroquinolones and the Risk of Retinal Detachment. JAMA. 2012;307(13):1414-1419. doi:10.1001/jama.2012.383

Lee C, Lee MG, Chen Y, Lee S, Chen Y, Chen S, Chang S. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA Intern Med. 2015;175(11):1839-1847. doi:10.1001/jamainternmed.2015.5389

Adel Alrwisan, Patrick J. Antonelli, Almut G. Winterstein; Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study. Clin Infect Dis 2017; 64 (8): 1052-1058. doi: 10.1093/cid/cix032

 

Floxie Hope Podcast Episode 21 – James

James is featured in Episode 21 of The Floxie Hope Podcast.

Check it out:

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

http://www.floxiehopepodcast.com/episode-021-james/

James also shared his story in writing, and you can read it here – https://floxiehope.com/james-story-hurt-by-metronidazole-then-cipro/. He goes into more detail in the podcast though, and I highly recommend that you listen in. Thank you for sharing your story, James!

James was 24 years old when he was floxed. He lost his grip strength after taking a single pill. After that, he experienced pain, burning pain in his legs, his eyes hurt, he had floaters in his vision, visual snow, loss of ability to sweat, weight loss, stiff and weak legs, nerve pain, brain fog, and anxiety.

He was acutely sick for 9 months. Even though he has recovered to the point where he is able to do his job again, he is not quite at 100% yet. He’s getting there though. He has a new perspective on health, healing, and happiness that is helping him immensely.

Thank you for listening to James’ insightful and uplifting story!

(Again, I apologize about the sound quality. There is still a lot of beneficial information in the podcast, despite the static and echoes.)

 

A Fluoroquinolone Toxicity Post Goes Viral

A post about fluoroquinolone toxicity, i.e. getting “floxed,” i.e. getting “ruined” by Cipro, has gone viral.

Check it out!

This antibiotic will ruin you.

It has been shared more than 10,000 times on Facebook (probably closer to 20,000 – the web site stops updating each share after 10,000 shares) – including more than 6,000 shares from The Fluoroquinolone Wall of Pain Facebook page.

It is resonating with thousands of people, who are not only reading it, they are sharing it. It has been viewed by MILLIONS of people. The author, Amy, posted on her facebook page that, in just a couple days, the post has been viewed more than 4 million times. That’s amazing!

Please shareThis antibiotic will ruin you with your friends and family. It’s getting through to people. It’s informing people. It’s connecting people.

Thank you, Amy, for sharing your journey and your story, and for doing it in a way that has resonated with so many people!

This post has done more to get the word out about the dangers of fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others) than 90% of the other posts, media stories, etc. that have been produced. It has gone viral. It has gone so viral that people are writing about it going viral, including WOMAN SAYS FLOUROQUINOLONES ANTIBIOTICS ‘WILL RUIN YOU,’ GETS 40K FACEBOOK LIKES on Inquistr.com (which, I believe is part of Buzzfeed), and, obviously, this post.

Viral posts aren’t something that happens every day, so, CONGRATULATIONS, Amy! Most importantly, her viral post, This antibiotic will ruin you, is increasing awareness about fluoroquinolone toxicity.

This antibiotic will ruin you has more than 1,000 comments on it – many of which are from fellow “floxies.” Amy has stated (on facebook) that she wants to respond to all of them, but that she’s drowning in the volume of comments. Can you, my friends in the “floxie” community, who are experts in fluoroquinolone toxicity, please help her? Please take some time to respond to some of the people who have commented on This antibiotic will ruin you. Your help will be appreciated!

The viral nature of the post has given us a window of opportunity to inform people about fluoroquinolone toxicity, and to support those who are going through it who didn’t realize that there is a support network available. Any help that you can provide in further spreading the post, and helping to answer comments on the post, will help. Thank you!

 

 

Happy Birthday Grandma!

grandma

Today is my Grandma’s birthday. Happy birthday, Gram! I hope you have a wonderful day!

My Grandma is one of my favorite people in the world and I love her very much.

My Grandma was incredibly, wonderfully supportive through my journey through fluoroquinolone toxicity. As soon as I said, “I’m sick,” before I even knew why or how I was sick, she took me seriously. When I realized what was making me sick, she never questioned me. She never downplayed or dismissed my experience with fluoroquinolone toxicity–she just believed me. She was always on my side, and it didn’t seem like it ever occurred to her to believe the medical establishment, or anyone else, over me.

When she broke her hip a few years after I got floxed, my Grandma immediately put Cipro on her list of medications that she was not to be given. She knew that it was dangerous because of what I had gone through, and she didn’t want what happened to me to happen to her. Her refusal to take Cipro meant a lot to me. It signified that she believed me, and that she didn’t believe that my reaction was something rare or dismissible. It meant that she listened. I write about my experience with fluoroquinolone toxicity not to relive what happened, or to wallow in it, but to warn people so that they don’t go through the same thing I did. It means a lot when people listen, and it meant a lot to me that my Grandma listened to me, and that she refused to take the drug that hurt me. I’ve never had to fight with a doctor about a fluoroquinolone prescription for a loved one, but, I’m pretty sure that if I did get into an argument with a doctor about whether or not a fluoroquinolone prescription was appropriate for my Grandma, she would take my side.

I am lucky in that I have a lot of wonderfully supportive people in my life. I always felt like everyone in my family loved me and wanted what was best for me. I have always known that I am loved and cherished. I have always known that all of my loved ones were on my side. They are all appreciated!

Not all “floxies” have supportive loved ones. Some people don’t believe that their floxed loved one is really sick. Some people don’t try to understand what their floxed loved one is going through. Some people have family members who are dismissive of fluoroquinolone toxicity, and who don’t believe that it’s “real.” Some people have family members who believe that fluoroquinolones can’t be dangerous, and that adverse reactions can’t be devastating, even though there is plenty of documented evidence that fluoroquinolones ARE dangerous and adverse reactions ARE devastating. It saddens me when I hear of people who are not supported by their loved ones as they go through the difficulty of fluoroquinolone toxicity.

I appreciate the support of all my family members, and, today, on my Grandma’s birthday, I am especially appreciative of her.

You are loved, Gram. Happy Birthday! xoxo

 

fluoroquinolone-lawsuit-banner-trulaw

Consumer Reports Warns Patients About Fluoroquinolone Dangers

consumer-reports-0816

Consumer Reports has published several articles about the dangers of fluoroquinolone antibiotics (including Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others). Their help in getting the word out to their readers about the risks associated with fluoroquinolone antibiotics is greatly appreciated!

The picture above, from the August, 2016 print issue of Consumer Reports, states:

These potent antibiotics are often prescribed to treat bronchitis, sinus infections, and urinary tract infections. But drugs such as ciprofloxacin (Cipro), levofloxacin (Levaquin), and ofloxacin (Floxin) can cause irregular heartbeats, depression, nerve damage, ruptured tendons, seizures, and other serious side effects. The Food and Drug Administration issued an alert in May saying that fluoroquinolones should not be used to treat bronchitis, sinus infections, and UTIs, unless other options have not worked.

Avoid Problems. If your doctor suggests a fluoroquinolone, ask why. For sinus infections, you might need an antibiotic if your symptoms last more than a week or if you have a high fever, but the first option should be amoxicillin. For a UTI, fluoroquinolones are only necessary if the infection is resistant to other antibiotics or has spread to your kidneys. And they are necessary for chronic bronchitis only if you require hospitalization.

In Fluoroquinolones Are Too Risky for Common Infections: The FDA advises restricting use of popular antibiotics such as Cipro due to dangerous side effects, Consumer Reports notes that the FDA “is advising against prescribing fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, to treat three common illnesses —bronchitis, sinus infections, and urinary tract infections.” The article also quotes Rachel Brummert, the Executive Director of the Quinolone Vigilance Foundation, and notes that her injuries from Levaquin include tendon ruptures and progressive nerve damage. The article also gives a guide of when to say no to fluoroquinolones. It’s an excellent article–please share it far and wide.

In Make Sure Your Doctor Prescribes the Right Antibiotic: There are safer, better options than fluoroquinolones and other frequently prescribed broad-spectrum drugs, the severe effects of fluoroquinolones are noted:

“For example, fluoroquinolone antibiotics such as ciprofloxacin (Cipro and generic) and levofloxacin (Levaquin and generic)—which are frequently prescribed inappropriately for sinus infections in adults—can cause permanent and debilitating damage to muscles, tendons, and nerves.”

As the title of the article says, there are safer, better options than fluoroquinolones (in many situations).

In Surprising Remedy for Deadly Hospital Infections: New study suggests doctors cut back on antibiotics. Here’s what you need to know. it is noted that fluoroquinolone use can lead to c. diff infections:

“Research published in The Lancet, a British medical journal, shows that when doctors in U.K. hospitals cut back on prescribing Cipro, Levaquin, and other so-called fluoroquinolone antibiotics, the rate of deadly infections from the bacteria known as C. diff dropped a whopping 80 percent.”

Fluoroquinolones wipe out the good bacteria that keep c. diff bacteria suppressed. When those good bacteria are eliminated, c. diff infections can take over. C. diff infections can be deadly, and all healthcare professionals should take note of this (somewhat counterintuitive) study.

All of the articles linked to above also note that fluoroquinolone over-use is contributing to antibiotic resistance.

In Meds That Cause Blurred Vision, Hearing Loss, and More: Painkillers, antibiotics, and other common drugs can trigger surprising side effects Cipro is listed as a drug that can cause double vision.

In I Didn’t Know That Antibiotics Shouldn’t Always be Used to Treat Bronchitis, Mary H. describes how Levaquin (prescribed to treat bronchitis) led to Stevens-Johnson Syndrome, which can be deadly.

All of these Consumer Reports articles are greatly appreciated, and I encourage you to read them, comment on them (where possible), and share them with your loved ones.

Consumer Reports has been a trusted source of information, and a strong advocate for consumer protection, since its founding in 1936. The articles linked-to above are from a highly respected source that is trusted by millions of people. It is a credible publication.

For a trusted and credible publication like Consumer Reports to be publishing information about the severe and varied health maladies that are associated with flouroquinolones is a huge step in the right direction. Their acknowledgement of the FDA’s updated warnings on fluoroquinolones, as well as the testimony of patients who have been hurt by fluoroquinolones, is appreciated immensely.

Thank you, Consumer Reports! Please keep it up, and hopefully other trusted news and consumer advocacy publications will follow suit.

 

 

Fluoroquinolone Toxicity and Other Illnesses are not Mutually Exclusive

Fluoroquinolone toxicity and other multi-symptom, chronic, illnesses are not mutually exclusive. It’s possible to be floxed and have Lyme Disease. It’s possible to be floxed and to have Epstein Barr Virus. It’s possible to be floxed and have an autoimmune disease. It’s possible to be floxed and have mercury or lead poisoning.

Often, people have to fight for fluoroquinolone toxicity to be acknowledged. Doctors, nurses, other medical professionals, as well as skeptical loved ones, will often dismiss fluoroquinolone toxicity as ” not real” or being “all in your (the patient/loved one) head.” When they suggest that fluoroquinolone toxicity isn’t real, they often suggest that maybe you, the patient/loved one, really have some other disease such as Lyme Disease, ME/CFS, fibromyalgia, lupus, M.S., Sjogren’s Syndrome, Epstein Barr, etc. This often puts floxies on the defensive, and they fight with their doctors to say, “No, I’m not sick because of ___ recognized illness, I’m sick because of fluoroquinolone toxicity. I was fine before I took Cipro, Levaquin, or Avelox. Now I’m sick. It’s the drugs.” You, the patient, the floxie, the person whose body hurts, is right. These drugs hurt you, and anyone who dismisses the possibility that fluoroquinolones can do serious, severe, and long-lasting harm to a person is wrong and misinformed. There is a massive amount of evidence of the damage that fluoroquinolones do to people. There are several mechanisms by which fluoroquinolones can cause multi-symptom, chronic illness. The warning labels on fluoroquinolones reflect that they are dangerous drugs with serious consequences. You ARE suffering from fluoroquinolone toxicity.

With that said, you may also have Lyme Disease, or Sjogren’s, or mercury poisoning, or something else. It’s possible, and I think that examining all possibilities for acknowledgement and treatment are helpful.

Having an autoimmune disease, or Lyme, or some other more acknowledged illness, does not mean that you aren’t floxed. As I just said, There is a massive amount of evidence of the damage that fluoroquinolones do to people. There are several mechanisms by which fluoroquinolones can cause multi-symptom, chronic illness. The warning labels on fluoroquinolones reflect that they are dangerous drugs with serious consequences. Fluoroquinolones are dangerous drugs. They are hurting, and disabling, too many people.

Illnesses do not always occur one at a time–they can occur simultaneously, and they can overlap. Definitions of diseases are fuzzy too, and if you want to read about how diseases are defined by the drugs that treat them (i.e., the pharmaceutical industry), read Dr. Terry Wahls’ book, The Wahls Protocol, in which she discusses how diseases are defined and developed.

Some people have suggested that fluoroquinolones trigger other diseases. Is this possible? Maybe. In I Believe I had a Predisposition on www.fluoroquinolonethyroid.com, JMR discusses the possibility that she had a predisposition toward autoimmune thyroid issues, and that fluoroquinolones triggered the expression of that illness. People have suggested that fluoroquinolones trigger the activation/release of dormant Lyme or Epstein Barr. In Do Fluoroquinolone Antibiotics Trigger Charcot-Marie-Tooth and Other Genetic Diseases? I discuss the possibility that fluoroquinolones trigger epigenetic changes in that lead to the expression of dormant genetic diseases. In Lead Toxicity: Secondary to Hyperthyroidism, Hyperparathyroidism . . . and Fluoroquinolone Toxicity?, JMR suggests that fluoroquinolones may have triggered the release/activation of lead in her body. Similarly, in Fluoroquinolones and Mercury Poisoning, I note that fluoroquinolones may trigger the release/activation of mercury in the body through the disruption of mineral homeostasis (or maybe through keeping the liver from detoxifying the body properly). Many people have noted that there is a huge amount of overlap in symptoms between fluoroquinolone toxicity and fibromyalgia, ME/CFS, and other “mysterious” illnesses of modernity. All these connections and possibilities should be explored.

The possible connections between fluoroquinolone toxicity and other illnesses doesn’t mean that fluoroquinolone toxicity isn’t real though. It is real–it’s very real. Whenever people assert that fluoroquinolone toxicity isn’t real, and that people are really suffering from some other illness, I always go back to the beagle puppies that were made lame by fluoroquinolones, and their precursor nalidixic acid. Those puppies may have had some sort of genetic predisposition toward being hurt by fluoroquinolones, but the damage done to them wasn’t really something else. Their lameness, their pain and suffering, was from the fluoroquinolones – period.

I also go back to the mechanism of action for fluoroquinolones. Fluoroquinolones are topoisomerase interrupters. The mechanism of action for Cipro/ciprofloxacin is:

The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

This video illustrates the mechanism of action for fluoroquinolones:

Fluoroquinolones have been shown to deplete mitochondrial DNA, and otherwise damage mitochondria.

The ARE dangerous drugs that ARE hurting people.

AND, you may have Lyme Disease, or lupus, or another illness, as well. So, get tested, and determine a course of action that treats all your symptoms and illnesses. These illnesses are not mutually exclusive, and knowing what you’re dealing with is key to understanding how to approach it. Of course, be careful with the treatments, but knowledge, and an open mind, are almost certainly helpful.

Multi-symptom, chronic illnesses are difficult to understand, and they’re even more difficult to treat. Dealing with multiple multi-symptom, chronic, mysterious illnesses is even worse. Luckily, the things that help people with fluoroquinolone toxicity are often similar to the things that help people with chronic Lyme Disease, or ME/CFS. So, please don’t feel disheartened or overwhelmed if you are facing both fluoroquinolone toxicity and another disease. Hang in there, and know that hope is helpful no matter what the ailment.

 

flu tox get help you need banner click lisa

Floxie Hope Podcast Episode 19 – Ian

ian1

I had the pleasure and honor of interviewing Ian for Episode 19 of The Floxie Hope Podcast.

Check it out!

http://www.floxiehopepodcast.com/episode-019-ian/

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Ian was an Olympic athlete prior to getting “floxed” by Levaquin. He has experienced severe fluoroquinolone toxicity symptoms, including multiple tendon tears that put an end to his cross-country ski racing career. Athletes should NEVER take fluoroquinolones. Ian went from being in the 2002 Olympics, to barely being able to walk around the block. If it can happen to him, it can happen to anyone. Please warn all your loved athletes so that they never take these dangerous, disabling antibiotics.

Ian is incredibly wise and insightful. His advice about how to face fluoroquinolone toxicity emotionally, mentally, socially, and psychologically is incredibly valuable. Please take the time to listen to him, and consider sharing this podcast with friends, family, and other loved ones. Ian’s measured and thoughtful voice of wisdom will help them to understand fluoroquinolone toxicity.

One thing that has recently helped Ian is KT tape. He posted this:

ian2kt

I had to let my body cure itself for 8 years, but then this KT and cloth tape job along with compromising my technique is what is enabling me to ski. I use about $25 worth of tape per week! I do this tape job on both legs every time I go out. I am very grateful to be able to ski some again!

Thank you all for listening!

I apologize for the poor sound quality. My voice echoes at the beginning of the podcast. Feel free to skip what I say – it’s not near as important as what Ian says. 🙂

 

flu tox get help you need banner click lisa

The Gaslighting of Patients

Gaslighting: A form of manipulation that seeks to sow seeds of doubt in a targeted individual or members of a group, hoping to make targets question their own memory, perception, and sanity. Using persistent denial, misdirection, contradiction, and lying, it attempts to destabilize the target and delegitimize the target’s belief.

Gaslighting occurs far too often to patients who experience adverse reactions to pharmaceuticals. Often, it is done by the people patients turn to when they are sick–our trusted advisors, our healers: our doctors.

I don’t think that most doctors mean to gaslight their patients, or that many of them are narcissists or abusers who intentionally manipulate people. I think that most doctors want to heal and help their patients. They use the information and tools that they have to move their patients toward health and well-being.

Yet, gaslighting is occurring.

When “floxed” patients approach their doctors with symptoms of fluoroquinolone toxicity (or FQAD-fluoroquinolone associated disability) they often face denial, derision, and hostility from the doctors who they are requesting help from. The doctors say that the symptoms that the patient is experiencing can’t be from the Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), or Floxin (ofloxacin), even though most of the symptoms of fluoroquinolone toxicity / FQAD are listed in the 40+ page warning labels. They say that the drugs should be out of the patient’s body, even though the black box warning label notes that fluoroquinolones “have been associated with disabling and potentially irreversible serious adverse reactions.” They say that they’ve never seen a patient who has had an adverse reaction to a fluoroquinolone–and that may be true, but are they looking? They say that delayed reactions can’t happen–but they’re documented. They deny that adverse reactions can happen, probably because they are in denial about the very real possibility that the drugs that they prescribe can cause serious, severe, and irreversible pain to their patients.

Then, they suggest that the patient see a psychiatrist and get on antidepressants.

Some people who experience adverse reactions to fluoroquinolones benefit from seeing a psychiatrist and taking antidepressants (though others are hurt further by both–be careful), and those things aren’t inherently bad, but the implication in suggesting psychiatrists or antidepressants is that patients who are experiencing adverse reactions to fluoroquinolones are crazy. We’re not crazy. Though some fluoroquinolone toxicity / FQAD symptoms are psychiatric, none of the symptoms, not even the psychiatric ones, are choices, decisions, or even the result of being crazy. All the symptoms of fluoroquiolone toxicity / FQAD stem from fluoroquinolone use and the damage done by these drugs.

fluoroquinolone-lawsuit-banner-trulaw

When a person, especially a doctor, suggests that all the symptoms of fluoroquinolone toxicity / FQAD are in a patient’s head, they are gaslighting the patient and making him or her feel crazy.

It’s dismissive, it’s obnoxious, sometimes it’s abusive, and it’s always wrong.

It happens all the time though, and I wish that it would stop.

Adverse reactions to fluoroquinolones (and other pharmaceuticals) are real, and they happen more often than they should. Denying that adverse reactions occur, then blaming the victim and telling him/her that he/she is insane, is not only useless, it is destructive. It hurts the patient/doctor relationship, and, more importantly, it hurts the patient. As I said above, I don’t think that many doctors intentionally seek to manipulate or hurt their patients. It’s happening though, and it needs to stop.

In the stories of patient pain and suffering from fluoroquinolones described on Fluoroquinolone Stories and The Fluoroquinolone Wall of Pain, doctor denial and gaslighting are described.

Sherry describes the gaslighting and denial that she experienced after taking Floxin and Flagyl:

“I went from doctor to doctor trying to convince them that these drugs did this to my body. They looked at me as if I had ten heads. They couldn’t believe that these medications could stay in one’s body for that long. I was crazy. I would bring them papers to show them proof and one doctor said to me that the medical community would use these papers for toilet paper!”

Cheryl notes the following experience after taking Ciprofloxacin XL:

“I went back to the pharmacist and told him the reaction I had. He said it can happen and it certainly sounded like I had an adverse reaction but he did not report it. I went back to the doctor how prescribed the drug to me and he did not believe me that I had reacted in that manner. Again, no reporting back to any authorities that I had an adverse reaction. I tried to show him the evidence of how many people have been damaged by this group of drugs and how dangerous they are and I was blown off. He told me he prescribes this drug all the time and has never had anyone react. I beg to differ because I bet people do have negative reactions but because they happen after the drug has been used, the connection between the aching muscles, nausea, anxiety, stiffness etc are not connected to the drug they took a month or more ago.”

There are many others.

Floxies are not alone in getting gaslighted by doctors. In the post “The Unintentional Gaslighting of Women and a Goodbye” Kerry Gretchen describes how her stroke that resulted from hormonal birth control wasn’t taken seriously by the doctors who treated her. Support groups for people who have had adverse reactions to a variety of pharmaceuticals and medical devices are full of patients who are frustrated and hurt when their doctor denies both their pain, and the cause of it.

The pain caused by pharmaceutical injuries is real, and patient pain should never be dismissed or denied. When denial of pain occurs, and patients are told that their symptoms are all in their head, it hurts the patient psychologically, and destroys the trust and bond between the patient and his or her doctor.

Doctors can stop this cycle through listening to their patients, not dismissing or disregarding adverse drug reactions as “rare” or “all in your head,” and being conscious of gaslighting as a phenomenon. Good, thoughtful, kind doctors don’t want to hurt or manipulate their patients, but, in order to maintain their worldview about the safety and efficacy of the drugs they prescribe, they often deny and deflect. Hopefully, with awareness of both gaslighting as a phenomenon, and how adverse drug reaction symptoms appear, the cycle will be halted.

 

flu tox get help you need banner click lisa

 

 

New Fluoroquinolones in the Pipeline

The most commonly prescribed fluoroquinolones are Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin. Almost every “floxie” that has been poisoned by fluoroquinolones in the last 15 years has taken Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin. However, there are many other quinolones and fluoroquinolones that have been developed. Here is a list:

First-generation:

Second-generation:

  • ciprofloxacin (Cipro) -Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • enoxacin (Enroxil, Penetrex) – withdrawn from the market
  • fleroxacin (Megalone, Roquinol) – withdrawn from the market
  • lomefloxacin (Maxaquin)  – withdrawn from the market
  • nadifloxacin (Acuatim, Nadoxin, Nadixa)  – withdrawn from the market
  • norfloxacin (Lexinor, Noroxin, Quinabic, Janacin)  – withdrawn from the market
  • ofloxacin (Floxin, Oxaldin, Tarivid) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • pefloxacin (Peflacine) – withdrawn from the market
  • rufloxacin (Uroflox) – withdrawn from the market

Third-generation:

  • balofloxacin (Baloxin) – withdrawn from the market
  • grepafloxacin (Raxar) – withdrawn from the market
  • levofloxacin (Leflox, Cravit, Levaquin, Tavanic) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • pazufloxacin (Pasil, Pazucross) – withdrawn from the market
  • sparfloxacin (Zagam) – withdrawn from the market
  • temafloxacin (Omniflox) – withdrawn from the market
  • tosufloxacin (Ozex, Tosacin) – withdrawn from the market

Fourth-generation:

  • clinafloxacin – Not withdrawn from market, but not commonly available
  • gatifloxacin (Zigat, Tequin) – Tequin removed from the U.S. market, but other forms remain available.
  • gemifloxacin (Factive) – Currently available. More commonly prescribed outside of the U.S.
  • moxifloxacin (Acflox Woodward, Avelox,Vigamox) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • sitafloxacin (Gracevit) – withdrawn from the market
  • trovafloxacin (Trovan) – withdrawn from the market
  • prulifloxacin (Quisnon) – withdrawn from the market

Despite the fact that 22 of the 29 quinolones listed above have been removed from the market, and the fact that there is an updated black box warning label (the most serious warning possible on a pharmaceutical), that notes that the fluoroquinolones remaining on the market can cause permanent disability, several pharmaceutical companies are busily developing new fluoroquinolones.

Some of the fluoroquinolones in development include:

  • Delafloxacin (Baxdela) – Delafloxacin/Baxdela is being developed by Melinta Therapeutics, and is currently undergoing Phase III trials. It is supposed to be more effective at treating MRSA and other bacterial infections that are currently resistant to other fluoroquinolones. Melinta says that delafloxacin/Baxdela has a “favorable safety profile,” but, frankly, I don’t believe them. Bayer says that Cipro has an excellent safety profile, but thousands of people have been injured, disabled, and killed by it. Delafloxacin/Baxdela will be effective against gram-positive, gram-negative, atypical and anaerobic bacteria–meaning that it will be a broad-spectrum antibiotic that will kill all microorganisms in its path. I understand that MRSA is a serious, and potentially deadly infection, and that it may be appropriate to use an extra-powerful fluoroquinolone in cases of life-or-death. However, as an extra-strong fluoroquinolone, with an increased scope of bacteria that it kills, it will be a dangerous, and deadly for some, drug. I hope that delafloxacin/Baxdela will be reserved for treating life-threatening MRSA infections, and that it will not be prescribed for treatment of simpler or less dangerous infections.
  • JNJ-2Q – JNJ-2Q is being developed by Furiex Pharmaceuticals, who have licensed JNJ-Q2 from Janssen Pharmaceuticals, a unit of Johnson & Johnson. Like delafloxacin/Baxdela, JNJ-2Q is being developed for the treatment of MRSA, and it is also a particularly strong and potent fluoroquinolone. Again, I hope that it is only used for deadly MRSA infections.
  • Nemonoxacin (Taigexyn) – Nemonoxacin/Taigexyn, developed by TaiGen Biotechnology Company, is currently undergoing phase III trials in the U.S. However, it has already reached the market in Taiwan, Russia, Commonwealth Independent States, Turkey, mainland China, and Latin America. It is also more effective against MRSA than the fluoroquinolones that are currently on the market, and it is more potent than ciprofloxacin, levofloxacin, and moxifloxacin. Not-so-fun-fact – Nemonoxacin has been fast-tracked for approval by the FDA.
  • Zabofloxacin – Zabofloxacin was discovered by Dong Wha Pharmaceuticals and licensed to Pacific Beach BioSciences for development. It is currently undergoing clinical trials. “The spectrum of activity of zabofloxacin includes bacterial strains that are responsible for most community-acquired respiratory infections. Phase III clinical studies are currently ongoing at Dong-Wha for the treatment of patients with acute bacterial exacerbation of chronic obstructive pulmonary disease.” (source)

Be aware that these new fluoroquinolones are in the pipeline. Know their names so that you can avoid them.

I’m not sure how anyone else’s medical record works, but when I asked my doctor to put that I am allergic to fluoroquinolones on my medical record, her computer system wouldn’t allow her to do so. Instead, I had to list all of the fluoroquinolones that I wanted to avoid individually. I suggest that you tell your doctors not only that you can’t have fluoroquinolones, but that you can’t have Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin specifically. And, when they reach the market, I suggest that you add Baxdela/delafloxacin, JNN-2Q, Taigexyn/nemonoxacin, and zabofloxacin to your list of drugs that you cannot tolerate.

I find the dissonance between the people who review drug safety, and the people that approve new drugs, both of whom are within the FDA, to be a bit mind-boggling. How could the Antimicrobial Drugs Advisory Committee decide that the current warnings on fluoroquinolones are inadequate and that they shouldn’t be prescribed for sinus infections, colitis or UTIs, or chronic bronchitis because they are too dangerous, while another part of the FDA fast-tracks the approval of Taigexyn/nemonoxacin, an even more powerful fluoroquinolone antibiotic? Do they not speak to each other? I can’t fathom that there is not at least some overlap between the Antimicrobial Drugs Advisory Committee and the people who approve new antimicrobial drugs. Are there people at the FDA who are screaming about these new fluoroquinolones that are about to enter the market, and noting that they are horribly unsafe? Or, did the Antimicrobial Drugs Advisory Committee just update the warning labels on existing fluoroquinolones to shut up patient advocates (you and me)? Is there massive cognitive dissonance at the FDA? Because it certainly appears that there is. The people at the FDA, and the Antimicrobial Drugs Advisory Committee specifically, pretend to acknowledge the dangers of fluoroquinolones, and pretend to do something about those dangers, while still thinking that it’s appropriate to approve new, stronger fluoroquinolones for public use. It’s mind-boggling.

There is constant repetition of some mantra along the lines of “fluoroquinolones have an excellent record of safety and efficacy” among drug-makers, drug-regulators, and drug prescribers – despite a massive amount of evidence to the contrary. The list of quinolones/fluoroquinolones above clearly shows that 22 of the 29 drugs have been removed from the market–many because of serious safety concerns. Yet, new, more powerful, fluoroquinolones are entering the market, in part because, for some odd reason, Cipro and Levaquin are seen as “safe.” They’re not safe though. They cause permanent disability and death. The upcoming fluoroquinolones will be worse.

I hope that the new fluoroquinolones that are coming to market are only used to treat life-threatening MRSA infections, but I have no faith that that will be the case. These new fluoroquinolones will be marketed as being bigger/better/faster/more powerful than safer alternatives, doctors will prescribe them, and patients will suffer because of them. Hopefully I’m being too pessimistic, and some prudence will be shown in the prescribing of these dangerous drugs–I doubt that though.

Just be aware of the dangers of fluoroquinolones–both old and new, and protect yourself and your loved ones. Share information about the dangers of fluoroquinolones with your friends and family, and let them know that fluoroquinolones should never be used unless there are no viable alternatives, and the infection is life-threatening. These new fluoroquinolones are more powerful, and more dangerous, than the fluoroquinolones that are currently on the market, and the ones that are on the market are pretty horrible. They should all be avoided like the plague.

 

flu tox get help you need banner click lisa

 

fluoroquinolone-lawsuit-banner-trulaw

Floxie Hope Podcast Episode 18 – Clara

I had the pleasure of interviewing Clara for episode 18 of The Floxie Hope Podcast.

Please check it out!

http://www.floxiehopepodcast.com/episode-018-clara/

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

You can download all episodes of The Floxie Hope Podcast through any podcatcher app that connects to iTunes.

In this episode of The Floxie Hope Podcast Clara goes over her fluoroquinolone toxicity symptoms, as well as some things that have helped her. She gives wonderful insight and advice!

After taking Cipro, Clara’s toxicity symptoms included:

  • Nausea
  • Loss of appetite
  • Insomnia
  • Loose teeth
  • Bleeding gums
  • Getting sick easily / suppressed immune system
  • Anxiety
  • Depression
  • Fatigue
  • Brain fog
  • And more

Clara has improved greatly with the assistance of a naturopathic doctor who focuses on balancing her hormones. She has also benefitted from an anti-candida diet, and several supplements. Please listen to the podcast for more information about her journey.

Thank you so much for being on the podcast, Clara! Your journey is inspirational and valuable!

 

ubiome logo

10% off uBiome kits to analyze your microbiome.

 

fluoroquinolone-lawsuit-banner-trulaw

Fluoroquinolones and Lead Toxicity

Several people have asked me to write a post about how fluoroquinolones may mobilize, or otherwise affect, lead in our bodies. I haven’t gotten around to doing the research that would be involved in writing a post like that, BUT, my friend and fellow “floxie” JMR did. I encourage you to read the post, “Love May Be Fleeting, but Lead Is Forever: Testing for Lead Toxicity” published on Hormones Matter.

The entire post is enlightening and informative, and I encourage you to read the whole thing. Here are some excerpts that are particularly enlightening and useful for “floxies.”

“A particularly interesting, and in my opinion, potentially significant “Lead Re-exposure” incident may have occurred when I took a fluoroquinolone antibiotic over six years ago. I experienced a severe, acute, and ultimately permanent adverse reaction to just a few pills, described in articles I previously wrote for this website, here and here.   Symptoms of “Fluoroquinolone Toxicity” appear to mimic many other conditions, and lead toxicity is one of them. I describe how these FQ antibiotics may have contributed to yet another bout of “Acute Lead Toxicity” within myself after taking these antibiotics here (Scroll down about 60% of the page to “V-ATPase:  Target for Osteoporosis /Adverse Effects”).  How do I know if that did or did not happen to me?  I don’t – because I didn’t know to test blood lead levels during the acute stage (first 6 months) of my reaction or beyond. But now that I do, I would recommend all severely affected fluoroquinolone victims monitor blood lead levels over time during the course of their reaction, especially during the acute phase and relapses, to see if this might be something occurring in this population. A nice summary in table form shows the biological fate of Lead and its clinical significance here.”

And:

“After that, it’s well accepted that overall mineral status is a factor. Lead competes with essential minerals such as calcium, iron, phosphorus, and zinc for the same receptors in enzymes, transporters, and in cell signaling processes.  Adequate concentrations of minerals can offset the small concentrations of lead found in background levels of foods and soils, and can only help if Lead exposure increases. Keeping a healthy balanced mineral status is probably one of the best defenses against lead toxicity, forcing lead excretion rather than binding to enzymes or storing in bone.  High concentrations of healthy essential minerals combined with low concentrations of lead levels is the best scenario, as essential minerals we need to function would be able to out-compete lead for enzymes, receptors, and transporters. On the other hand, low concentrations of healthy essential minerals combined with high lead levels would be a worst case scenario for potential toxicity. Children and adults eating healthy diets with adequate minerals will probably experience less toxicity to the same exposures of lead than someone who is deficient in calcium, iron, phosphorus, zinc or other minerals. Unlike when I was a young child, there is so much more knowledge and awareness about minerals and their importance today, and the internet makes this type of information easily accessible. A vast array of mineral supplements are available as well, making this an easy approach to help with prevention.  A nice lead-related summary of nutrients can be found here:  Fact Sheet: Nutrients That Reduce Lead Poisoning.”

The whole post is filled with great information, and I encourage each of you to read it. It also contains a list of links and resources that is immensely valuable to anyone interested in learning more about lead as it relates to illness.

Thank you for checking it out, and a huge THANK YOU to JMR for the post!

More information about the connections between fluoroquinolone toxicity and lead poisoning can be found on JMR’s web site, www.fluoroquinolonethyroid.com, on the post “Lead Toxicity: Secondary to Hyperthyroidism, Hyperparathyroidism . . . and Fluoroquinolone Toxicity?

This article, “Osteoporosis, lead, and baby boomers: When time gets the lead out.” is also full of excellent information.

fluoroquinolone-lawsuit-banner-trulaw

FDA Gives Up on Meaningful Patient Safety Measures, Instead Changes Warning Labels

 

A friend* forwarded me a few pharmaceutical industry articles about the November, 2015 FDA hearing regarding fluoroquinolone safety and labeling. The articles are interesting because they show the pharmaceutical industry perspective on the hearing and fluoroquinolones. They are also valuable to us as patient and drug-safety advocates because they are difficult to access—The Pink Sheet articles are typically behind a $1,000+ paywall, and neither The Pink Sheet nor The RPM Report are easily accessible by the public.

The Pink Sheet article was surprisingly balanced and thoughtful, while the RPM Report article was dismissive of patient pain (attributing patient symptoms to social media bandwagoning is a bit…. dickish). However, both articles acknowledge that the patient testimony provided at the November, 2015 FDA meeting was moving, and that people described serious and severe adverse-reactions to fluoroquinolones. It also seems that the pharmaceutical industry is somewhere between resigned-to and supportive-of the updated warning labels on fluoroquinolones. Perhaps I’m reading things into the articles that aren’t entirely there, but they seem to be a bit perplexed as to what to do about Fluoroquinolone Associated Disability–FQAD–which is mentioned by name in both articles, despite it not being an official and recognized label.

Interestingly, the pharma articles bring up a few things that I wholeheartedly support (that they don’t necessarily support, they just mention these things). Before I go into the programs that I support (that are actually brought up in the pharma articles because they aren’t happening, not because they are), I think that we should examine the pharma reaction to the updated warning labels. Why might pharma not continue to fight the updated warning labels?

Perhaps because they know that updated warning labels will not significantly impact fluoroquinolone prescription rates, or their profits.

During the FDA hearing, the pharmaceutical industry fought the updated warning labels on fluoroquinolones, but, as I described in THIS POST, they didn’t fight the updated warning labels because severe/accurate warning labels change prescribing behaviors or cut into their profits, they opposed the warning label updates because warning label updates open the door for patients to sue the pharmaceutical companies for harm caused by their products. Other than that, warning label changes don’t do much at all.

I’m proud of the fluoroquinolone-injured community for all the advocacy and work that went into getting the November, 2015 FDA hearing, and updated warning labels. Those things are accomplishments that should be celebrated. But we should also ask the questions—will those updated warnings actually make a difference? Will doctors stop prescribing Cipro, Levaquin, Avelox, Floxin, and their generic equivalents, for treatment of uncomplicated urinary tract infections (or cystitis), sinusitis, and chronic bronchitis? Will patients and physicians recognize that fluoroquinolones can cause disabling and potentially irreversible serious adverse reactions? The black-box warning notes these things, but will people actually read the updated warning labels and change their actions accordingly?

I hate to say it, but I suspect that the answers to the questions above is no. I think that pharma is resigned to updated warning label as a risk mitigation strategy. They understand that there needed to be a response to the heart-wrenching testimony provided by people whose lives have been devastated by fluoroquinolones, and that the rate of permanent disability resulting from fluoroquinolones reported in the FDA adverse events reporting system (FAERS) is entirely unacceptable, so they went along with a “solution” that they hoped would appease those who have been hurt by fluoroquinolones—an updated warning label.

They know though, that an updated warning label won’t dramatically change how fluoroquinolones are thought of or prescribed. The earlier warning labels were already significant, and though the acknowledgment that comes with seeing, “Fluoroquinolones, including CIPRO®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: Tendinitis and tendon rupture, Peripheral neuropathy, Central nervous system effects,” is important, what really matters is changing the way that fluoroquinolones are prescribed so that people aren’t unnecessarily hurt by dangerous, disabling pharmaceutical drugs.

The RPM Report notes how the conversation shifted, in the FDA meeting, from concern for those harmed to concern about “communicating risks”:

“DSaRM committee member Tobias Gerhard (Rutgers) said that the evidence from FAERS is not supported yet by epidemiological data but that the distinction of whether it’s a syndrome or not is ‘somewhat secondary’ to communicating risks to separate disabling effects and future work can assess whether there is a syndrome.”

Mr. Gerhard is wrong. The problem isn’t that people aren’t being warned sufficiently, The problem is that PEOPLE ARE BECOMING DISABLED BY FLUOROQUINOLONES AND THAT FLUOROQUINOLONE ADVERSE-REACTIONS MANIFEST AS A SYNDROME. Both the FDA, and the pharmaceutical industry, seem to think that the problem is a lack of awareness, and that updating fluoroquinolone warning labels will solve the problems that FQAD patient advocates are advocating for.

I think it will behove us, as drug-safety advocates, to recognize that this is what they’re doing. They shift the conversation from harm-caused to risks-communicated. They seem to think that it’s okay for an an antibiotic to cause permanent harm and disability as long as people were warned. They can shift the responsibility from the drug-manufacturers, who should be held responsible for the harm their product causes, to the consumer, who they claim “was warned.”

This happens with many dangerous drugs and medical devices, not just fluoroquinolones. The FDA and Bayer responded to patients screaming about how Essure, a permanent contraceptive device, had caused pain and disability to thousands of women, by putting a black box warning on Essure. They didn’t do anything meaningful—like discontinuing Essure because there are safer forms of permanent contraception—they just adjusted the warning label.

flu tox get help you need banner click lisa

Is the FDA so weak that they are incapable of forcing pharmaceutical companies to take responsibility for the dangerous products they create? Apparently. Their inability to take responsibility for the dangerous drugs they peddle means that consumers, you and me, must beware, because we’re taking dangerous drugs at our own risk.

They’ll pretend to actually “do something” by having meetings, hearings, and changing the warning labels. They know that those things won’t actually keep people from getting hurt by dangerous drugs though.

However, the Pink Sheet and The RPM Report articles note that there are a few meaningful things that can be done to change how fluoroquinolones are thought of and prescribed. They mention these things not as suggestions, but rather as a note of things that are not occurring. The Pink Sheet article points out that the FDA failed to call for a Risk Evaluation and Mitigation Strategy (REMS) for fluoroquinolones after the November, 2015 meeting, and the RPM Report points out that no epidemiological studies have been done for fluoroquinolones. Both a REMS and a thorough and well-funded epidemiological study of fluoroquinolones would be real, meaningful steps toward patient safety and quantifying the damage done by fluoroquinolones.

REMS are “required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks.” FDA published overviews of REMS can be found HERE.

Per the FDA, “FDA can require a REMS if the agency determines that safety measures are needed beyond the professional labeling to ensure that a drug’s benefits outweigh its risks,” and, “If FDA becomes aware of new safety information* (*New safety information is defined as a serious risk associated with use of the drug which FDA has become aware since the drug was approved, since a REMS was required, or since the last assessment of the REMS) and determines REMS is necessary to ensure that the benefits of the drug outweigh the risks.”

A REMS could, for example, do the following (and more):

  • Require a positive and responsive bacterial culture prior to the prescription of any fluoroquinolone.
  • Require that other antibiotics be tried, and/or ruled out, before a fluoroquinolone is prescribed.
  • Require that medical providers go over the black-box, and other warnings and precautions, with patients prior to prescribing and administering fluoroquinolones. (It would be nice if things like delayed adverse reactions, tolerance thresholds, and the fact that there is no cure for FQAD, were included in the review as well.)
  • Require that liver function tests be performed prior to prescribing or administering fluoroquinolones. (We are a ways off from knowing exactly what liver tests may be predictive of adverse reactions to fluoroquinolones.)
  • Require genetic tests for MTHFR and other mutations prior to prescribing or administering fluoroquinolones. (We are a ways off from knowing what genes predispose people to adverse reactions to fluoroquinolones.)
  • Require that additional warnings and education be provided to patients in high-risk categories such as those with a history of autoimmune disease, neurodegenerative disease, psychiatric illness, athletes, children, etc. (Studies need to be done to determine exactly who is at higher risk of fluoroquinolone adverse reaction.)
  • Initiate a campaign of “Dear Healthcare Provider” letters to educate healthcare providers about the risks associated with fluoroquinolones.
  • A REMS could also start a database to help track fluoroquinolone recipients, as well as their adverse-reactions.

All of those would be substantial steps toward minimizing inappropriate fluoroquinolone prescriptions, and reducing the number of people suffering from serious adverse-reactions.

However, the FDA decided not to require a REMS. Instead, they adjusted the warning labels.

The Pink Sheet states:

The decision not to require a REMS to address the risk of disabling side effects with the antimicrobials (fluoroquinolones) could reflect agency wariness about potentially cumbersome risk management programs for the widely prescribed drugs, particularly given its recent experience with REMS for the long-acting/extended-release opioid products.”

The REMS for long-acting/extended-release opioids involved voluntary education for healthcare providers, and “a recent advisory committee review of the REMS showed the number of prescribers completing the training was far below the target goal.”

So, because the REMS for an entirely different class of drugs–long-acting/extended-release opioids–failed, we don’t get a REMS for fluoroquinolones.

A REMS that was similar to the REMS for long-acting/extended-release opioids, that only involved voluntary education for healthcare providers, would be too weak to make much of a difference anyhow, in my opinion. Yes, doctors need to hear about the serious, severe, disabling, and deadly adverse-effects of fluoroquinolones, but without any restrictive prescribing guidelines, that knowledge wouldn’t actually keep many patients from getting hurt by fluoroquinolones.

The Pink Sheet notes:

Given lingering questions about the effectiveness of the ER/LA opioids REMS – at least in the eyes of the FDA and its external advisors – the agency may be more inclined to try to reduce the risks of fluoroquinolone use through labeling changes rather than imposing another complicated risk management program.”

It sounds to me like the FDA has given up on using REMS as a tool. They’ve given up on a tool that could meaningfully improve patient safety. Now the FDA just changes warning labels and tell patients “you were warned” when they suffer from severe adverse drug reactions. They know that’s not actually doing anything to make patients safer, right? They know that they have tools at their disposal that could make patients safer, right? They’re just choosing not to use those tools. They have given up on meaningful patient safety regulation. It’s sad, really.

Perhaps epidemiological studies are needed in order for the FDA, pharma, and healthcare providers to understand the real and serious effects of fluoroquinolones, and after they get some epidemiological study results they will order a thorough REMS (we can always hope). However, it should be noted that no epidemiological studies have been performed examining fluoroquinolones as they relate to chronic disease or disability.

The RPM Report article states that there have not been epidemiological investigations of fluoroquinolone associated disability – “FDA Division of Epidemiology II Director Judy Staffa said they agency has not found any epidemiological investigations of the syndrome,” and:

“Many FQAD events are not hospitalized and it is not clear what codes may be used; patients also often have symptoms from multiple body systems so may see many different physicians. She (Debra Boxwell of the FDA’s Division of Pharmacovigilance) said there are challenges and expenses with trying to get medical charts for validation, acknowledging that there would ‘certainly be a lot of prescriptions of fluoroquinolones in the system.'”

Yes, there certainly are challenges with performing epidemiological studies of fluoroquinolones and their effects. The delayed adverse reactions, tolerance thresholds, and diffuse and bizarre nature of the adverse-effects make epidemiological studies difficult to perform. But the difficulty in performing adequate and informative epidemiological studies doesn’t mean that they shouldn’t be performed, or that information potentially gleaned from an epidemiological examination of FQAD wouldn’t be something on which policy-changes could be based.

The post, Dear Epidemiologists, Consider Fluoroquinolones, and its introduction on this site, go over some suggestions for epidemiologists who are willing to look into FQAD, and the potential relationship between fluoroquinolones and the various diseases of modernity that fluoroquinolone toxicity symptoms resemble. I hope that the FDA, or some other institution, will perform a well-designed epidemiological study that examines whether or not there are significant links between fluoroquinolones and other disabling syndromes such as autoimmune diseases, “mysterious” diseases like fibromyalgia and ME/CFS, psychiatric illnesses, diabetes, and more.

The only studies that I know of that are examining FQAD are the UCSD Fluoroquinolone Effects Study, and the Lucine Health/Hormones Matter Fluoroquinolone Antibiotic Side Effects Survey, and I do not know if either one is receiving funding from, or corroborating with, the FDA. From what I know about these studies, they will document the severe and disabling effects of fluoroquinolones, but I am not sure whether or not they will examine links between fluoroquinolone use and other disabling, chronic diseases. Epidemiological studies that quantify the extent and severity of fluoroquinolone associated disability still need to be conducted.

Both epidemiological studies, and a REMS, should be performed in order to assess fluoroquinolone safety. According to The RPM Report:

there are about 32-33 million retail prescriptions annually for quinolones, with about two thirds for ciprofloxacin. Levofloxacin generates about 10 million annually. The other drugs are now very rarely prescribed.”

Yet we have no real notion of how many people are being hurt and disabled by fluoroquinolones because no epidemiological studies have been done. Healthcare providers have no notion of what procedures and precautions take when prescribing fluoroquinolones because there is no REMS to provide guidance. Fluoroquinolones are dangerous, and sometimes disabling, drugs. Yet, rather than doing something meaningful to quantify or mitigate the risk of fluoroquinolone adverse-reactions, the FDA has chosen to simply increase the size and content of the warning labels for Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and other fluoroquinolones. The FDA seems to think that risk-communication is the problem, but it’s not—the problem is that fluoroquinolones are dangerous, disabling drugs, and that nothing is being done to quantify or address those risks.

Interestingly, pharma seems to know that the proper thing to do is to quantify the risks posed by fluoroquinolones in epidemiological studies, and to mitigate their risks with a REMS. They wouldn’t have mentioned those approaches in their industry publications if they didn’t think that epidemiological studies and a REMS were appropriate measures for the FDA to take.

The FDA didn’t take the opportunity to order an epidemiological study, or a REMS, at the November, 2015 meeting though. Instead, they changed the fluoroquinolone warning labels. It’s what they do now. They’re publishers, not regulators or patient-protectors.

Even pharma seems surprised at their ineptitude.

* The friend who sent me the Pink Sheet and RPM Report articles is Nick Newell. When I asked him if I should use his name he said, “I think there’s already too much secrecy and anonymity around questions of drug safety – that’s part of the problem. So if you do post it, please feel free to use my name.” Nick lost his brother Oliver to fluoroquinolone toxicity. You can read the Newell family tribute to Oliver and description of fluoroquinolone adverse reactions HERE. Nick and his sister are featured in the news story that can be viewed below, and his testimony at the 11/15 FDA hearing can be read starting on p. 275 of this transcript. He is an advocate and a friend, and he is greatly appreciated.

Neither Fluoroquinolone Toxicity, nor Recovery, are Rare

Last weekend I went to a seminar that has absolutely nothing to do with fluoroquinolones, drug safety, or advocacy. In that seminar I sat next to a guy who was roughly my age (30-something), and I began to tell him about my experience of getting hurt (poisoned) by Cipro/ciprofloxacin. I was about ten seconds into my story when he said, “Me too – Levaquin.” Yup, he was a fellow floxie. We chatted for a while, and exchanged stories of fluoroquinolone toxicity, then got back to the seminar.

There are a few things about my exchange with him that I’d like to share. First, he has largely recovered. He got hurt by Levaquin about a decade ago. He had severe musculo-skeletal problems (but not a lot of the nervous system symptoms that many floxies experience), and experienced pain in all the joints in his body. He went from being young, athletic, and capable, to barely being able to move. His pain and loss of capacity was so bad that he went through periods of contemplating suicide. Thankfully, he made it through those dark and painful times. He didn’t give me many details about how he got through the last decade, but he did heal. All of his joints (with the exception of his knees) are now strong and pain-free. He is able to work, socialize, and has recently started to exercise again.

The main thing that helped him was time. Knowing that time had helped others through similar experiences also gave him hope that his body would recover if he gave it enough time. For him, the amount of time that it took for his body to recover was a decade. I know that ten years is a long time, and for some of you it may sound like an unbearably long time. For others though, I hope that it is helpful and hopeful that time healed this guy’s body, and that maybe, just possibly, if you give yourself enough time, your body will heal too. (Of course, I don’t know how much time will heal you, or even if time will heal you, but I see it as hopeful that time healed him – even if it was a long time.)

The second thing that struck me about my conversation with this guy is that if two people meet in a random seminar, and both of them have had a life-altering adverse reaction to the same class of drugs, maybe that’s an indication that these reactions aren’t as “rare” as Bayer, Janssen Pharmaceuticals (a division of Johnson & Johnson), the FDA, and all others in the pharma machine would like us to believe. A floxie friend noted the following in a brilliant essay she wrote as part of a legal analysis about the alleged “rareness” of fluoroquinolone reactions:

Another way the risks are minimized is by listing these reactions as temporary or rare. The latter may be true in a technical sense, but what does ‘rare’ actually mean? A quick search of fluoroquinolone victim online support groups reveals that membership for most of them numbers in the tens of thousands, and the FDA’s Adverse Event Reporting System database garnered 3,101 reports of severe adverse reactions to fluoroquinolones in the last quarter of 2013 (the latest data available) alone. These are unscientific and anecdotal statistics, of course, but given that this class of antibiotic was prescribed to approximately 26.9 million patients during 2011 in the United States alone, ‘uncommon’ translates to 2.69 million domestic victims and ‘rare’ translates to 269,000. In fact, many more probably exist but are given a catch-all diagnosis of an ambiguous auto-immune disorder like fibromyalgia or are labeled with some other malady like diabetes, heart disease, hypothyroidism, etc., that arose spontaneously. Also, as in my case, a patient may take one or more courses previously without suffering an entirely noticeable reaction. Additionally, there is an unwillingness of medical professionals to admit a connection between the drug and these reactions. This is perhaps because, at first blush, it seems to defy logic that symptoms could take months to fully develop. But further research into biochemical complexities such as neurotransmitter and mitochondrial dysfunction is likely to explain why the damage follows a cascade-like pathological effect. For these reasons, the individualized nature of the reactions, and of course the patient’s illness itself, many victims surely never make the connection.

Of course disabling adverse reactions don’t happen to everyone who takes fluoroquinolones, but I still believe, as the author of the quote above does, that adverse reactions to fluoroquinolones are far less “rare” than pharma proponents would like us to believe, and that they are connected to many of the “mysterious” diseases of modernity for many.

fluoroquinolone-lawsuit-banner-trulaw

My encounter with the guy in the seminar also made me think that there are a lot more recovered “floxies” out there than most of us realize. In a comment on her story, Ruth noted:

My neighbor got floxed two months after I did. She made a 100% recovery. We had similar issues, but I was slightly worse than her. Until she talked to me she had no idea what had happened to her.

The music director for the parochial school/church where I worked two years ago got floxed, made an almost 100% recovery. She had some issues with her knee, having had a complete rupture of a tendon there and she is not young. But everything else resolved.

One of the pharmacy techs where I got the Cipro is a Floxie. She was very kind to me when I came there after my reaction. She was not there the day I picked up my prescription or maybe she would have warned me. She is 100% recovered.

My mother also knows someone who made a 100% recovery after a very bad reaction to a quinolone.

I don’t think that fluoroquinolone adverse reactions are rare, and I don’t think that recovery is rare. I also know that not everyone who gets hurt by fluoroquinolones recovers, and that there are many, too many, people who are permanently injured by Cipro, Levaquin, Avelox, Floxin, and their generic equivalents. Permanent injury, and Fluoroquinolone Associated Disability (FQAD), are not near as “rare” as they should be. None of the damage done by flurooquinolones is as rare as it should be. Too many people are getting hurt by these dangerous drugs. Even if many of them recover, poisoning people with dangerous and consequential drugs, when there are safer alternatives available, is wrong, and I hope that it stops soon.

 

flu tox get help you need banner click lisa