Bucknell University Study Regarding GI Issues and Fluoroquinolones

Dr. Cecelia Bove, PhD, is conducting a study of the gastrointestinal effects of fluoroquinolones, and she is seeking participants to answer questions about their gastrointestinal health post-fluoroquinolone-exposure.

Dr. Bove is looking for more survey participants, and I encourage all floxies to participate. To participate in the study, please send an email requesting a link to the study to cb068@bucknell.edu (the email address on the flyer pictured above bounced, but I was able to reach Dr. Bove through cb068@bucknell.edu). Dr. Bove will send you an email with a link to the study. As advertised, completing the study takes about 15 minutes. The questions are mainly about GI health.

Dr. Bove described the study as follows:

“The purpose of this research is to gain insight into a possible correlation between the intake of fluoroquinolones and permanent damage to the brain areas that regulate the gastrointestinal tract. I am a neuroscientist, and my PhD focused on this issue in the context of another illness, Parkinson’s Disease. My goal is to eventually examine the molecular changes that occur following the administration of fluoroquinolones in animal models, but I would first like to understand the nature of gastrointestinal symptoms that arise after FQLs administration. Despite being fairly known that this is the case, very little research is available describing the nature of gastrointestinal issues. A fairly easy, not time-consuming way to assess this, is through the survey I am inviting you all to fill. It is a short (15 minutes) long survey, in which we will ask you some questions about your gut health. The data gathered from the survey is completely anonymized to protect your identity and stored confidentially solely for analysis purposes. My goal is to gather enough responses (~500) to publish in a peer-reviewed journal and, based on the result, reach out to the FDA and the European Drug Administration to modify the current warnings on FQLs.

This would ultimately be my first paper published on gut health and FQLs. As I said earlier, my expertise was on Parkinson’s Disease, and now that I am a faculty at Bucknell University I have the opportunity to pursue my own research plans. My laboratory is now composed of me and two undergraduate students. We have all undergone training to do human research according to the Institutional Review Board (IRB) to ensure the protection and quality of this type of research. If you are interested in reading more about my previous research, you can find me on pubmed, researchgate, or google scholar. My main co-author was Travagli R.A., so that would help you narrow down the results.”

Those of you who follow my journey may know that my one remaining lingering symptom of fluoroquinolone toxicity is inflammation in my gut. This inflammation results in loose stools, the feeling of a hot coal in my belly at night, insomnia (sometimes), and I even had surgery on my lower GI tract late last year to fix a somewhat embarrassing issue. None of these GI issues inhibit my life terribly. I’m able to work, eat, sleep well enough, live without too much pain, etc. But the inflammation is still there, and it’s a bit worrisome. My GI issues got notably worse years after I got floxed, so it’s difficult to say whether or not they’re connected to the ciprofloxacin I took years ago. I would like to know if the connection exists though, and perhaps Dr. Bove’s study can help to establish connections between fluoroquinolone use and long-term GI problems.

As Dr. Bove noted in the quote above, the survey is anonymized, so your medical information will be secure.

I hope that Dr. Bove gets enough survey participants to draw meaningful conclusions from the data collected, and I encourage you all to participate. Thank you!

*****

 

Recovered Life – Lisa’s Update

A few things have happened since I last posted. Here are some thoughts on the events that have occurred in my life and in the world, and how they relate to FQ toxicity.

I went on a big hike in the middle of July. I hiked 75 miles of The Colorado Trail from Molas Pass to my hometown, Durango. I hiked ten miles a day for the first three days, and 15 miles a day for the following three days. It was beautiful and I enjoyed it and I am glad I did it, but it was also really hard. Everything hurt while I was hiking, and it took me longer than I expected to recover.

I hiked the entire ~500 mile Colorado Trail (from Denver to Durango) in 2010, a couple years pre-flox. I was 30 at the time. It was great, and even though I remember parts of it being really difficult, I also remember feeling really strong while doing it and after I finished.

The 75 miles I hiked this year (2020), at age 40, felt hard and exhausting. I’m ten years older, and I was floxed in the last decade – and I think both of those factors led to the pain and exhaustion I experienced.

BUT, I fully realize that I shouldn’t complain about pain or exhaustion from hiking 75 miles. I was, after all, ABLE to hike 75 miles in 6 days, and for that I am incredibly grateful. I couldn’t have done that through most of my thirties because of fluoroquinolone toxicity. For a long time my body was too weak to do a major multi-day backpacking trip. I have considered myself to be recovered for a while, and now my body is able to do really difficult physical activities again. It’s good, and I am grateful for the recovery I have experienced. I also hope that stories like this help those reading this to imagine the possibility of doing physically difficult things post-flox. Hiking 75 miles was hard, but my post-flox body was able to do it.

Here are some pics from my trip:

After returning from my Colorado Trail journey I adopted a couple kittens from the local Humane Society. Their names are Johnny and Bobby and they’re adorable and I love them to pieces already.

There’s a lot of angst in the world right now. I feel angsty and fearful and I am quite certain that I am not alone in those feelings. Kittens help. Not that I got them because of stress or politics or general angst – I got them because I love cats and my beloved Rickie-cat passed away at the age of 17.5 in late-June and I wanted/needed some kitty-love in my home. With that said, kittens are making my world a lot happier. I also think that the love of a pet is healing, and that it may even help with getting through fluoroquinolone toxicity (as it did for Gigi – you can read her story of healing with the love of a pet HERE).

Here are Johnny (tabby) and Bobby (black):

Of course, the big thing going on in the world right now is COVID-19. It sucks. Everything about it sucks. That’s my in-depth analysis on COVID (and probably all global pandemics).

I have posted a few things about hydroxychloroquine on my facebook page – some pro, some anti. My main opinion on it at this point is that everyone – EVERYONE – is subject to confirmation bias. The doctors who have used hydroxychloroquine “successfully” are subject to confirmation bias (even the non-crazy ones). Of course doctors are biased just like everyone else – that’s why double blind randomized controlled studies are necessary. The “peer reviewers” and editors at the Lancet, one of the oldest and most respected journals, are also subject to confirmation bias, as shown by the fact that they were quick to unquestioningly publish a study full of fraudulent data that showed that hydroxychloroquine was not effective and that it actually caused harm. Their confirmation bias made them unable to see obvious flaws in the study (“A first-year statistics major could tell you about major flaws in the design of the analysis”). The WHO halted all studies of hydroxychloroquine for treatment of COVID-19 based on the Lancet-published (fraud-filled) study – and the WHO decision-makers should have known better and checked their bias too. No one at the Lancet or the WHO bothered to check their bias against the drug, and every single one of them should have known better. The job of peer reviewers and journal editors is to question what they are given, and the Lancet reviewers and editors failed miserably at doing so. The article that I’m referring to has been retracted by the Lancet, and you can read all about the scandal around it by searching “lancet hydroxychloroquine article retracted.” Anyhow… double-blind randomized controlled studies are necessary to eliminate confirmation bias. The randomized controlled studies of hydroxychloroquine have shown that it is not an effective treatment against COVID-19. This will probably come as a relief to many floxies because many people who have had a disastrously awful reaction to fluoroquinolones are understandably hesitant to take a drug that has a similar chemical structure. Hopefully alternative treatments will be available to most floxies (and everyone else) who end up getting COVID-19.

Many of you already know this from the comments on the floxiehope home-page, but I should mention to those who just read the posts that our friend Henk Noordhuizen passed away on June 10, 2020. His loss is grieved by the Floxie Hope community as well as his friends and family. Henk was an outspoken advocate for victims of fluoroquinolones, and his advocacy and friendship are missed.

I am assuming that most of you would rather read posts that contain helpful information about fluoroquinolone toxicity rather than posts that update you about my life. I am sorry for not having the time, energy, or inclination to write those in a while. I encourage all my floxie friends who have something to say about fluoroquinolones to submit a post for publication on this site. I’m happy to put up posts written by other people. Also, this site was originally intended to be a place where people could share their stories of hope and healing from fluoroquinolone toxicity, not a blog for me. But it morphed into a bit of both, and I think that both have been good. As I get slower on the blogging bit (out of laziness, forgetting the pain of fluoroquinolone toxicity, other things going on in my life, etc.) I hope that this site is still a place where people can share their stories of healing from fluoroquinolone toxicity. I’m still publishing inspirational stories from brave and wonderful people who have recovered from fluoroquinolone toxicity. If you have a story of hope and healing, please reach out. Thank you!

I wish all my floxie community hope and healing! xoxoxo

*****

 

 

 

Sick Friend, Sick Family, Sick World

This post is going to be a bunch of things that I’ve been thinking about. There isn’t necessarily a theme or connection between any of them, but they are things that I want to share, and even discuss (feel free to comment below), with the floxie community.

***

First, Henk. Henk Noordhuizen has been contributing to the floxie hope community through his comments on the site (primarily the home page) for several years. He has provided information, insight, support, advice, humor, and friendship to the community through the years that he has been floxed. He is appreciated and adored by many. Sadly, Henk has recently been diagnosed with cancer of the esophagus. He is very weak and his prognosis is poor. I’m so sad about his illness, and I know that many others are too. Henk is in my thoughts, and I wanted to let others in the floxie community know what is going on with him so that they/you can send healing thoughts (and prayers if so inclined). If any of you want me to forward messages to Henk, please send them to me through the Contact link above, and I will send them to Henk. Thank you. And, Henk, if you read this, know that we are thinking of you. Hugs!

***

Next, some COVID-19 stuff. I don’t know any more about COVID-19, or what to do about it, than anyone else, so I’ll keep my thoughts and opinions brief.

It’s bizarre that use of hydroxychloroquine for treatment of COVID-19 has become a politicized and polarizing issue. I suppose that it’s because Trump mentioned it, so now support or opposition of use of hydroxychloroquine is an indicator for whether a person supports or opposes Trump. This whole line of thinking, on both sides, is nonsense. It’s a drug. It has effects, and it has side-effects. With proper studies and experiments it will either be shown to be a safe and effective treatment for COVID-19, or it won’t. Randomized double blind studies have not yet been performed though, so we honestly don’t know how safe or effective hydroxychloroquine is for COVID-19 patients. I’m sure we’ll know with time whether or not it is considered a safe and effective treatment for most people (though not all people – some will suffer from adverse reactions that may be awful). Hydroxychloroquine has been around for a while, and we do know that it has some serious “side effects” (I really hate that term because it doesn’t encompass the horror of adverse drug reactions) that are worrisome. It is also chemically similar enough to fluoroquinolones that I think it’s appropriate for the “floxie” community to be cautious and wary of it. As I said in my last post, I would try to avoid it if possible, but that’s just me. I also think that it’s ridiculous to be either for or against hydroxychloroquine as a potential treatment for COVID-19 based on politics, and I’m glad that Trump has never said a thing about fluoroquinolones.

A lot of people who get COVID-19 are going to join the unfortunate “club” of those who are chronically ill, and it is likely that many of them will also join the unfortunate “club” of those who have been hurt by pharmaceuticals. Unfortunately, there are going to be some COVID-19 victims who are also floxies because, sadly, co-infections are being treated with fluoroquinolones. It’s all sad and scary and I’m not sure what else to say about it other than to point out the obvious that YOU DON’T TREAT VIRUSES WITH ANTIBIOTICS.

***

On another, personal, topic – my Dad had a pacemaker put in about 10 days ago. The electrical system for his heart stopped working entirely, and we are all lucky that his backup system kicked in (apparently some people don’t have a backup system, or it doesn’t kick in), and that he had an appointment with a cardiologist when he did. The cardiologist said that people who have a heartbeat that is as slow and erratic as my Dad’s was usually come into the ER on a stretcher. As soon as my Dad got to the cardiologist’s office, he was told that he’d have to have a pacemaker put in ASAP. They did so that day, and he is now doing well. The pacemaker saved his life – the doctors who diagnosed him and put in the pacemaker did too – as did the entire medical system that made his surgery possible. This is the second time that medical interventions have saved my Dad’s life. The first time was about 15 years ago when he had cancer (non-hodgkin’s lymphoma) and a single round of chemo kicked it. We have been lucky and grateful twice.

It’s hard to be angry with the medical system when it saved my Dad’s life twice – once very recently. I’m grateful that pacemakers exist, that the surgery is so remarkably uninvasive, and that he is doing well. This in no way negates that I wish that the medical system was better at acknowledging, treating, and even curing multi-symptom chronic illnesses – especially those caused by pharmaceuticals. I don’t want to throw the baby out with the bathwater as they say, but I do want the bad drugs, and bad doctors, and bad practices, and bad studies, to be abandoned as they deserve. I think, and hope, that there’s room for both embracing the good and criticizing and abandoning the bad. I hope that our collective criticism of the medical system makes it better. It needs to get better – it is hurting too many people. But it also saves people, and right now, I am grateful that my Dad’s life was saved and that he is doing amazingly well.

*****

Fluoroquinolone Toxicity Featured on The Doctors

After years of multiple people writing, tweeting, and otherwise advocating for fluoroquinolone toxicity to be featured on the show, The Doctors, it finally happened. Whoo hoo!

In the April 2020 episode of The Doctors that goes over fluoroquinolone toxicity, one of the host doctors, Dr. Ordon, discusses his journey through getting “floxed”. Dr. Ordon took a fluoroquinolone to treat chronic prostatitis. It should be noted that most cases of chronic prostatitis are NOT bacterial, and that fluoroquinolone antibiotics are no better than a placebo at treating non-bacterial prostatitis (https://floxiehope.com/2015/04/15/cipro-is-no-better-than-a-placebo-at-treating-chronic-prostatitis-chronic-pelvic-pain-syndrome/). Unfortunately, Dr. Ordon had an adverse reaction to the fluoroquinolones he took. Dr. Ordon’s symptoms of fluoroquinolone toxicity that were discussed on the show include achilles tendinitis and muscle atrophy.

Dr. Ordon was helped by Dr. Mark Ghalili of Regenerative Medicine LA. On the show, Dr. Ghalili discusses some of the treatments he prescribed for Dr. Ordon including a customized IV treatment and growth factor injections.

Dr. Ghalili also discusses his journey through fluoroquinolone toxicity. Dr. Ghalili was in a wheelchair and unable to care for himself for months after taking a fluoroquinolone. He also suffered from brain fog and other adverse effects. You can learn more about his journey on Episode 25 of The Floxie Hope Podcast.

In addition to the help that Dr. Ordon received from the treatments provided by Dr. Ghalili, the host doctors also discussed the importance of time and patience for Dr. Ordon to get through fluoroquinolone toxicity.

This episode of The Doctors will certainly bring fluoroquinolone toxicity awareness to the thousands of people who watch the show. All those that made the episode possible are greatly appreciated!

You can view the fluoroquinolone toxicity feature on The Doctors here:

*****

Floxed in the time of COVID-19

The world has shifted. Most of us started the year as if 2020 was going to be a continuation of the norm of 2019, but the world shook, and all assumptions are now out the door.

We are dealing with a global pandemic. COVID-19, the novel coronavirus, has reached every state in the U.S. and most nations in the world. It has killed thousands of people, and it will almost certainly kill thousands more.

Governments have reacted to COVID-19 by declaring national (or local) emergencies, closing borders, stopping travel, shutting down places where people gather (including restaurants, bars, beaches, churches, etc.), closing schools, locking down nursing homes and retirement communities, telling people to stay home from work, and more. These actions have enormous consequences for our economy, and the reach of the ripple-effects are, and will be, far and wide.

I worry about my community—Durango, Colorado. I worry about the virus reaching Durango. As I write this, no cases have been confirmed in my community – but I’m sure that the day is coming when someone in the community will have, and spread, the virus. I worry about the pain, suffering, and death that will bring. I also worry about the effects of the reactions to COVID-19 on my community. I worry about all the people with young kids who can’t go to school for the next month who now must choose between their job(s) and leaving their kids at home alone. I worry about the people who can barely make ends meet while working full-time who are getting their hours cut because we won’t get tourists this year. I worry about the medical workers who must be exposed to sick people as part of their jobs.

I worry about the floxie community and my floxed friends as well. Floxies are susceptible to viruses just like anyone else, and they are also affected by economic fluctuations. Most of my floxed friends have been hurt economically by fluoroquinolones – losing jobs, money, marriages, relationships, and much more because of fluoroquinolone toxicity – and being further economically hurt by COVID-19 is likely to push some of them over the edge.

I worry about many things and many people.

All this fretting. I wish it was helpful, but, alas, it isn’t. But perhaps it may be helpful for someone reading this to hear that someone else cares and is worried about them. People care enough to worry – I do.

I don’t know any more about the ever-changing COVID-19 virus situation than anyone else. However, I do have a few thoughts on how it might affect those who have been floxed. As always, please keep in mind that I’m not a doctor and these are not opinions that are informed by any medical education, they are simply my opinions and thoughts. Here they are:

  1. If you are not on immunosuppressive drugs, I don’t think that COVID-19 will be any more dangerous for you than it is for anyone else. Yes, I know that fluoroquinolone toxicity makes your immune system go haywire, and that fluoroquinolone toxicity looks and feels a lot like various autoimmune diseases. But, I believe that what makes people with autoimmune diseases more susceptible to infections is the immunosuppressive drugs they are often on, not the autoimmune disease itself. HOWEVER, when COVID-19 (and ebola, and a lot of other viral infections) kills people, it is by over-reaction of the immune system in a process called a cytokine storm. So, if floxies have an over-reactive immune system they may be more likely to experience a cytokine storm. I haven’t seen any research saying that floxies are any more likely to experience a cytokine storm than anyone else though, and I assume that floxies are no more, or less, likely to be infected with or experience complications from COVID-19 than anyone else.
  2. Apparently, people who survived SARS and MERS often experience severe ongoing chronic fatigue after they recover. COVID-19 is related to both SARS and MERS, though whether or not there are ongoing fatigue-related effects of COVID-19 is still to-be-determined. A lot of floxies experience severe and intractable fatigue, and even though my fatigue wasn’t near as bad as that of many people, the thought of virus-induced chronic fatigue scares the crap out of me.
  3. NSAIDs can make COVID-19 infections worse. NSAIDs suck. Here are a couple articles about NSAIDs and COVID-19 as well as a couple posts about how NSAIDs are bad for floxies.
    1. The Guardian, “Anti-inflammatories may aggravate Covid-19, France advises
    2. Floxie Hope, “Why NSAIDs Suck for Floxies (and Probably Everyone Else Too)
    3. Floxie Hope, “NSAIDs and FQs Damage Mitochondria, Increase Oxidative Stress, and Cause Cell Death
  4. Chloroquine is being explored as a potential treatment for COVID-19. It is related to fluoroquinolones, but it is NOT a fluoroquinolone. It’s more of a cousin, or even second-cousin, drug. Is chloroquine contraindicated for people who have been floxed? Probably…. But I have not seen any studies showing that. Still, the precautionary principle should rule in most circumstances, and I wouldn’t touch it. In addition to its quin structure, problems with chloroquine include:
    1. It can cause retinal toxicity and blindness.
    2. Both chloroquine and ciprofloxacin are lysosomotropic drugs. People who are smarter than me should read “Lysosomal cell death at a glance” to figure out what that means.
    3. Chloroquine inhibits thiamine uptake, and depleted thiamine is related to many chronic illnesses (you can read about the connections between thiamine, mitochondrial health, and chronic illness on hormonesmatter.com).
    4. Both fluoroquinolones and chloroquine can lead to serious cardiac problems, including arrhythmia and cardiomyopathy, both of which can lead to death.
    5. Both fluoroquinolones and chloroquine can cause tinnitus, and tinnitus can be miserable.

As I said, I wouldn’t take it if it was avoidable. (I am not under the impression that people quarantined in a hospital have much liberty or choice over what drugs go into their bodies though, and I doubt I would be able to make that decision if faced with treating COVID-19 – hopefully I am being pessimistic on that front and body autonomy isn’t actually relinquished when in the hospital…. But I still hope to never be in the situation to find out.) Chloroquine is a serious and consequential drug that may be particularly consequential for people with a history of adverse reactions to fluoroquinolones, but, I want to caution against a total knee-jerk reaction against any drug or substance with “quin” in its name. For example, pyrroloquinoline quinone (PQQ) is a mitochondrial support supplement that many floxies have tried without incident – and its name is even scarier than chloroquine. My approach to chloroquine is to avoid it until it is proven safe for floxies, and hope that it won’t be forced upon me. I’m not a doctor and my approach may not work for others, but it’s my two cents for anyone who wants my thoughts on the matter.

We are still at the early stages of the COVID-19 pandemic, and I have no clue what the future will hold. I hope that the pain and suffering brought on by this disease is minimized as much as possible. I hope that the floxed community emerges from this difficult time without too many additional scars.

Hugs,

Lisa

*****

Fluoroquinolone Toxicity Studies

A couple fluoroquinolone toxicity studies are being conducted.

Dr. Charles Bennett, a Professor at the University of South Carolina College of Pharmacy, is conducting a study of genes related to fluoroquinolone toxicity. Dr. Bennett is seeking “floxed” participants in the study. In the “Floxed Friday” newsletter sent out by Michelle Polacinski – Floxie, Director, and Producer of ‘Floxed’ – the following information about how to participate was shared:

This study is open to those who have experienced FQ Toxicity. If you are interested in participating, please send your contact information (name, address, phone #) to abc8@email.sc.edu and please write “FQ Study” in the subject line.

You will receive instructions, a consent form, and a survey to complete. A saliva test kit will then be mailed to you. You will provide your saliva sample, as instructed. Then, you will mail the sample back to the university, as instructed.

This is very exciting! This study has the potential to answer questions about who is predisposed toward fluoroquinolone toxicity, and, as genetic testing gets easier and easier, perhaps it will someday lead to screening tools that will keep doctors from prescribing fluoroquinolones to people who are genetically predisposed toward fluoroquinolone toxicity.

I encourage you all to participate in the study. (FYI – just my personal experience – I emailed my information to the email address provided twice, but have not yet heard back from anyone, so I don’t have any personal experience of this study. I just have heard about it and I’m passing on the information I heard.)

Another study of fluoroquinolones is being conducted by the Mayo Clinic (the branch in Rochester, Minnesota). It is a clinical trial entitled, “A Study to Evaluate Biomarkers of Fluoroquinolone-induced Mitochondrial Toxicity” and more information about it can be found on the Mayo Clinic web page about the study.

Per the clinical trial announcement:

“The purposes of this study are to determine if patients treated with fluoroquinolone (FQ) antibiotics have depletion of mitochondrial DNA (mtDNA) in buccal swab samples, and whether the degree of depletion correlates with the likelihood of developing FQ-associated toxicity.”

This is a very exciting study for the floxed community in a couple ways. First, it is to determine whether or not mtDNA is depleted in humans. Several studies have shown that fluoroquinolones deplete mtDNA in cells studied in labs, but I don’t believe that any studies have shown the depletion of mtDNA in people.

The study requires recent administration of a fluoroquinolone antibiotic (the inclusion criteria includes, “Treatment with oral and/or intravenous FQ antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, delafloxacin) that has been initiated upon, or within 24 hours of, admission to the HIM service or at time of initial Infectious Diseases consultation and lasting > 48 hours.“) so I don’t recommend that any floxed people sign up for it. Some people have expressed dismay over fluoroquinolones being studied by being given to people, and, while I understand the misgivings, fluoroquinolones are given to people all the time and I feel encouraged that there are people who are studying the effects of fluoroquinolones, even if the study requires administering them. I am assuming that the people who are a part of the study will be in-need of antibiotics and that fluoroquinolones would be given to them regardless of whether or not they participate in the study – I at least hope so, because giving these drugs to people who don’t have an infection or other need for them is unethical.

I appreciate the acknowledgement that is implicit in both these studies. In studying both genetic markers and mtDNA depletion as they relate to fluoroquinolone toxicity, fluoroquinolone toxicity is being acknowledged by the scientists and doctors conducting the studies. Acknowledgement is helpful in that it leads to studies which lead to more information which lead to fewer people getting hurt by fluoroquinolones and/or maybe even a cure for fluoroquinolone toxicity. We can at least hope for those things.

*****

Are Damaged Mitochondria Causing Autoimmune Diseases?

Fluoroquinolone toxicity looks and feels a lot like multiple autoimmune diseases including rheumatoid arthritis, lupus, MS, thyroid autoimmune diseases, and others. Some people have proposed that fluoroquinolone toxicity is its own autoimmune disease, but the auto-antibodies have not yet been identified and thus it is not treated as an independent autoimmune disease. In some people, fluoroquinolones have triggered a recognized autoimmune disease, as you can read about in Michelle’s Story of fluoroquinolone-induced lupus, JMR’s story of fluoroquinolone-induced thyroid autoimmune diseases, and I know a couple people with fluoroquinolone-induced MS.

I have always wondered what the connections are between fluoroquinolone toxicity and autoimmune diseases, whether or not fluoroquinolones are truly triggering autoimmune diseases generally, and what the mechanism is behind the connection.

A recent article in Scientific American, Brain’s Dumped DNA May Lead to Stress, Depression: New research suggests genetic material from the mitochondria can trigger an immune response throughout the body provides some interesting connections (and, dare I say, answers). The article points out that mitochondrial DNA, when it is released from mitochondria, can cause inflammation and an immune response:

“But how was this inflammation triggered by mitochondrial DNA leaking out of cells? A 2010 Nature paper provided the answer: In it researchers demonstrated the way mitochondrial DNA, when released into the blood after an injury, mobilized a pro-inflammatory immune response. Because of mitochondria’s bacterial origin and its circular DNA structure, immune cells think it’s a foreign invader.  When circulating mitochondrial DNA binds to a particular receptor, TLR9, on immune cells, they respond as if they were reacting to a foreign invader such as a flu virus or an infected wound. The immune cells release chemicals called cytokines telling other white blood cells they need to report for duty at sites of infection, inflammation or trauma.”

Multiple studies have shown that fluoroquinolones disrupt the replication and reproduction cycles of mitochondrial DNA (mtDNA) and deplete mtDNA. Of course they do – mitochondria are descendants of bacteria and drugs that affect bacterial DNA have similar effects on mtDNA. The way that fluoroquinolones work is that they disrupt the DNA and RNA replication cycles for bacteria (and mitochondria).

When mitochondrial DNA is released via fluoroquinolones (or a variety of other pharmaceuticals and environmental toxins that also damage mitochondria) the immune system attacks it because it appears to the immune system to be bacterial DNA. This attack of loose mtDNA can lead to an immune-system over-response, and even trigger an autoimmune disease.

The Scientific American article also notes that:

“The genetic cast-offs are not just inert cellular waste. “This circulating mitochondrial DNA acts like a hormone,” says Martin Picard, a psychobiologist at Columbia University, who has been studying mitochondrial behavior and the cell-free mitochondrial DNA for the better part of the last decade. Ejection of mitochondrial DNA from the cell mimics somewhat adrenal glands’ release of cortisol in response to stress, he says. Certain cells produce the circulating mitochondrial DNA and, as with the adrenal glands, its release is also triggered by stress.”

To emphasize – “circulating mitochondrial DNA acts like a hormone” that “mimics somewhat adrenal glands’ release of cortisol in response to stress.” So many people suffering from fluoroquinolone toxicity are in vicious cycles of chronic stress and anxiety that are wreaking further havoc on their health. The post, “Cellular Stress, Chronic Stress, and Fluoroquinolone Toxicity” goes into more detail about the connections between stress and anxiety and fluoroquinolone toxicity.

Fluoroquinolones aren’t the only toxins that damage mtDNA. The list of pharmaceuticals that damage mtDNA include all bactericidal antibiotics (including fluoroquinolones) (1), statins (2), chemotherapy drugs (3), acetaminophen (4), metformin (a diabetes drug) (5), and others. The environmental pollutants that have been shown to damage mitochondria include rotenone, cyanide, lipopolysaccharide, PAH quinones, arsenic, and many others (6).

I would bet quite a bit that the rise in autoimmune diseases corresponds with the rise in production of pharmaceuticals, pesticides, herbicides, and other chemicals that are toxic to mitochondria. The Scientific American article, Brain’s Dumped DNA May Lead to Stress, Depression: New research suggests genetic material from the mitochondria can trigger an immune response throughout the body, provides some valuable connections that point in that direction, and I would love to see more research on the topic.

 

*****

 

 

Patience and Kindness

Perhaps it’s because of the winter solstice dark and cold, or because 2019 was a particularly bad year for some people, or because being floxed SUCKS, or because of fear, or because nuance can be difficult to convey via the internet, or because of a million other potential reasons for ill moods, but it seems to me that people have been particularly impatient, rude, and even hateful on the floxie facebook pages and groups–including the floxie hope page and the fluoroquinolone wall of pain page, both of which I manage. I’m pretty decent at ignoring unpleasant things and avoiding confrontation, but the comments that are mean-spirited are starting to bother me. Perhaps in recognition of the holiday spirit or the change of the year (and decade), I would like to make a request – can y’all please be nice?

No one knows the perfect way to go through fluoroquinolone toxicity. No one knows the correct way to cure this. Everyone is experimenting and trying their best. Some people try things that they hope will be helpful or curative that have hurt others. The people who try these things are not stupid or trying to rub an adverse reaction in anyone else’s face. Sometimes knowledge of best practices shifts and what someone tried years ago is now known to hurt floxies. It stinks, but it happens. There’s no need to belittle people for what they tried years ago – or what they tried yesterday. People are doing their best to heal with the information they have. Feel free to give more information, but I would like to ask people to please be thoughtful when “correcting” others.

A common criticism on the floxie hope facebook page is that posts are old. Yup – some of them are. This site has been around for 6.5 years – since June, 2013. I put older posts up on the floxie hope facebook page because I figure that some people will still get value out of the posts. I sincerely hope that they are helpful, hopeful, or otherwise valuable to some of the people who see them. I also don’t think that 6 years is that long, or that a 6-year-old post is less valuable than a 6-hour-old post. However, if some of the information is out-dated or incorrect, I apologize. I did the best I could at the time I wrote each post, and I’m still doing my best now. I try to post accurate and backed-up information, but sometimes I’m wrong about an assertion. It happens. I’m a blogger. This site is my blog, not a peer-reviewed journal. I have always tried my best to be correct, but I don’t have the resources to verify any of my assertions about the causes or effects of fluoroquinolone, so please take everything I write with that grain of salt.

I also put up old posts because, frankly, I’ve gotten tired of doing fluoroquinolone research, putting together pieces of information from various sources, and formulating thoughtful and informative posts. I don’t have the emotional or intellectual energy to do that like I used to. I apologize. I wish I still had that energy and passion. But, to be honest, it has waned. I miss the passion that I once had, and I feel like the posts I have written in the last year-ish are not particularly inspired (or interesting). I would LOVE to have thought-provoking, interesting, inspired, passionate posts on this site, and I invite anyone who is interested in putting a post on floxiehope.com to send me what they’d like to post. This site has a decent-sized audience and it’s a good way to say what you want to say about fluoroquiolone toxicity to the community. Please let me know if you’re interested in writing for floxiehope.com (through either clicking THIS LINK or on the pic below).

One more thing that is a bit tangential – Facebook is cracking down on a lot of sites and groups, and I hope that the fluoroquinolone toxicity community on Facebook doesn’t get hurt by the crackdowns. I don’t think I’m breaking any FB rules, but even without thinking I’m breaking any rules, I’m still having some issues. This notice is currently on the fluoroquinolone wall of pain facebook admin page:

I clicked on the “learn more” link and, as far as I can tell, all rules have been followed. But maybe I did something inadvertently that was against facebook’s rules. Or, maybe they’re wrong. Either way, facebook has a massive amount of power to affect our reach and our ability to spread the word about fluoroquinolone toxicity, and if they shut down the pages and groups related to fluoroquinolone toxicity, well, that will be an awful shame. Facebook has facilitated the growth of this community (as I’m writing this, the Fluoroquinolone Toxicity Group on Facebook has 10,761 members). It has facilitated people sharing information about this illness, recovery, coping, etc. I am grateful to Facebook for all that it has offered. But what it gives, it can take away. I’m slightly worried that a wrong move can result in the disillusion of a major meeting-ground for floxies. I hope that we can continue to use facebook, and it would be a shame if we couldn’t and had to start over on a different platform. If you have a problem with something that is posted on the floxie hope facebook page or the fluoroquinolone wall of pain facebook page, please contact me rather than reporting it to facebook. Maybe then we can stay in their good graces.

*****

Mitochondria Summit

I just had surgery (just a couple hours ago as I write this), so this post is going to be short and sparse. BUT, I wanted to let you all know that there is a summit about Mitochondria that is happening THIS WEEK (December 9-15). You can access it through clicking on the image above, or through THIS LINK.

Fluoroquinolones damage mitochondria, and have been shown to deplete mitochondrial DNA. More information about the damage done to mitochondria (the energy-producing organelles of our cells) can be found in these posts:

Study Finds that Ciprofloxacin Depletes Mitochondrial DNA

New Study Finds that Ciprofloxacin Depletes Mitochondrial DNA

More posts about how fluoroquinolones damage mitochondria can be found through doing a search for mitochondria on floxiehope.com, and through searching for “mitochondria” on the links & resources page where you can find media and journal articles about the effects of fluoroquinolones on mitochondria.

In their April 27, 2013 Pharmacovigilance Review, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” the FDA describes the damage done to mitochondria by fluoroquinolones:

Ciprofloxacin has been found to affect mammalian topoisomerase II, especially in mitochondria. In vitro studies in drug-treated mammalian cells found that nalidixic acid and ciprofloxacin cause a loss of motichondrial DNA (mtDNA), resulting in a decrease of mitochondrial respiration and an arrest in cell growth. Further analysis found protein-linked double-stranded DNA breaks in the mtDNA from ciprofloxacin-treated cells, suggesting that ciprofloxacin was targeting topoisomerase II activity in the mitochondria.

The FDA Pharmacovigilance Report also notes that mitochondrial damage (and the ensuing oxidative stress that occurs when mitochondria are damaged) is related to multi-symptom, chronic diseases like optic neuropathy, neuropathic pain, hearing loss, muscle weakness, cardiomyopathy, lactic acidosis, Parkinson’s, Alzheimer’s and amyotrophic lateral sclerosis (ALS).

I am excited to hear what the mitochondria experts featured in the Summit have to say about healing mitochondria, possibly un-doing the damage done by fluoroquinolones, and maybe even how to prevent the diseases associated with damaged and depleted mitochondria.

One of the featured speakers is Dr. Terry Wahls, author of The Wahls Protocol, that has helped many floxies including Renee and Jamieson. You can read Renee’s story HERE and you can listen to her podcast HERE and you can read Jamieson’s story HERE. Dr. Wahls was also featured on The Floxie Hope Podcast and you can listen to her interview HERE.

I’m also excited to hear Bridgit Danner, LAc, FDNP discuss the effects of toxic mold on mitochondria, and to hear Michelle Sands, ND discuss the hormone-mitochondria connection, and to hear Jason Prall discuss microbiota-mitochondria communication, and to hear what many more wonderful speakers have to say about mitochondria.

I look forward to spending the next couple days relaxing, recuperating, and recovering from my surgery while learning lots about mitochondria.

I think it will be helpful for floxies, and give insight into healing our mitochondria. It’s THIS WEEK – please let me know your thoughts in the comments below. We can all learn together. 🙂

Floxed Friday – Why Don’t You Sue?

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’m writing this next to a large window and a view of falling snowflakes, gently floating down to the ground below, causing accidents and exciting skiers everywhere.

Skiing is a big, big deal for me. I learned when I was 4 years old in the middle of the woods in Upstate New York. My dad, a trophy-winning freestyle skier, known for his backflips and helicopters, gave me a pair of used thrift store Rossignols with the chickens at the top and gave me poles meant for a much taller child as we hopped over sticks and fallen trees together.

After racing on a team in high school and teaching skiing for 6 seasons, it’s easy to see that I’m enamored with the sport.

Skiing was and still is one of my favorite activities. When I was floxed, I couldn’t walk or hike for awhile. I was one of those floxies who crawled to the bathroom and lost 20 pounds in merely weeks.

I was no professional athlete floxie, but come winter, I was terrified that I would never ski again.

I was one of the lucky ones. While many floxies remain forever disabled, forever unable to walk again or run again, I got better and could ski again. To be fair, skiing is not a tendon-heavy sport, so it was easier to get back into it than, say, rock climbing or weight lifting or running or whatever other people do to stay fit.

I’m not bragging about it at all, but I was able to go backcountry skiing a couple days ago after we got a huge snowstorm and discussed my *former* disability with another skier I met there.

“Why don’t you sue?”

He actually didn’t ask me that question, but most people do when I talk about getting floxed. The answer is a complex one.

Many have tried and many have failed to win, including successful lawyers with floxed loved ones or doctors who have been floxed themselves. Lawsuits, including class action ones, have come and gone since the late 70’s, but fluoroquinolone antibiotics are still on the market because “there is enough warning for patients,” and “look at all those black box warnings!”

We disagree. We think that there needs to be much more education about Fluoroquinolone Toxicity, for medical professionals especially, but also better informed consent for patients.

It’s easy to blame the doctor who prescribed the antibiotic, but the fact of the matter is that many doctors are not adequately warned of the risks themselves. Doctors, like Mark Ghalili, DO, have been floxed. If that’s not an example that they are not properly informed, I don’t know what is. Today, Fluoroquinolone Toxicity is regularly taught in medical schools all over the USA, but I want it to be a mandatory lesson.

It’s regular practice for pharmacy technicians to remove the lists of warnings and pamphlets about the drug in order for it to be “easier” for patients, or so they say.

Who is to blame, really? Is it the drug itself? The drug had no intention. It’s an object, a creation. Is it pharmaceutical companies? Pharmacists? Investors?

Many floxies choose to blame themselves. “I shouldn’t have taken that drug,” they lament. “It probably happened because I’m too old, I was too sick, I took ibuprofen for a headache, I didn’t read the pamphlet, I have the MTHFR gene, I didn’t Google it, etc. etc. etc.”

It’s easy to blame the victim, even when the victim is never at fault . . . so who is to blame?

Instead of focusing on the blame, I’m focusing on solutions. Our team is focusing on how we can end this floxie epidemic once-and-for-all, with adequate educational campaigns and, hopefully, a huge, awesome documentary. Let us know if you want to help with the campaign and we’ll add you to a list for when the time comes.

Look out for YET ANOTHER podcast (originally recorded in June, I think!) coming out next week. We talk about how I became a filmmaker and get a little more into what it’s like to work in the film industry.

Have a great weekend and thank you for your continued support!

Best,

Michelle
Floxie, Director, and Producer of ‘Floxed’
#nonewfloxies #floxeddoc

*****

Your Illness is Not Your Fault

In my recent post (“Reluctantly Going to the Doctor“) I wrote about getting a minor surgery to address an “issue” and I had a couple more things I wanted to say about it.

When my issue was getting addressed, I asked the doctor if there was anything I could do to avoid having the same issue in the future. He said that it’s just one of those things that happens, and that there’s nothing that anyone can do to avoid it. It wasn’t because of anything I ate, or did, or didn’t do – it was just one of those things that happens. Hopefully it won’t happen again, but if it does, I know who to visit to get it take care of.

Hearing “it’s just one of those things that happens” was actually really nice and refreshing. Even though he didn’t explicitly say it, I heard, “it’s not your fault,” and that future issues wouldn’t be my fault either. It just happens. Sometimes parts of the body malfunction.

For those of us with fluoroquinolone toxicity, we know what caused our issues. They didn’t “just happen.” We were poisoned. And the answer to the question of what can be done to avoid fluoroquinolone toxicity is simple – don’t take fluoroquinolones.

With any sort of difficult-to-treat illness, there are always guesses regarding what to do, how to treat the illness, and how to prevent symptoms in the future. This site is filled with advice around all those questions. Every person who has written about their experience and shared their input regarding dealing with fluoroquinolone toxicity has meant well and has wanted to help, and the stories of hope and healing on this site have helped thousands of people through fluoroquinolone toxicity. But I worry about that line between suggesting things that are healing and blaming people who don’t do the things that are supposed to be healing. Not healing from fluoroquinolone toxicity doesn’t mean that you haven’t eaten the right things, or that you haven’t gotten the right treatments, or that you haven’t spent enough money. Fluoroquinolone toxicity happens first and foremost because people are exposed to fluoroquinolones, but symptoms persist because of all sorts of reasons, most of which are mysterious. Healing happens too, and we can point to reasons and ways that we think our body has healed, but the truth is that healing is mysterious too. Healing happens. The body has amazing healing capacity. But sometimes it doesn’t.

Neither are your fault. No matter what you ate, or what you drank, or what pre-existing health issues you had when you got floxed, or how your infection happened, or any other life factor, your illness is not your fault.

Of course I hope that you find healing. I hope that you find some tools that help you to heal too, and I hope that this site helps you to identify those tools. But if you don’t find the things that help, or if your body just doesn’t heal, it’s not your fault.

I think that letting go of anger and self-blame is healing, and I hope that this post helps some people to stop blaming themselves for their illness. I know that I dealt with a lot of guilt and self-blame in my journey through fluoroquinolone toxicity, and I hope that hearing, IT’S NOT YOUR FAULT, helps someone through their journey.

******

I wrote the above paragraphs in early November 2019 and a few things have happened to me health-wise since. The issue that I had a minor surgery for didn’t heal properly, and now I have to have a more major surgery. The next surgery will involve general anesthesia, and a few weeks of recovery time. I’ve never been a fan of general anesthesia, and have always considered it to be a bit scary. Fluoroquinolone toxicity adds to my fear of it. If any of you have advice for going through surgery post-flox, or anesthesia, please don’t hesitate to contact me. Thank you!

******

Unnatural Selection

I’m watching the Netflix series Unnatural Selection right now (as of typing this, I’m watching episode 2 of season 1). It’s about genetic editing through CRISPR-Cas9 and it is fascinating. Whether you love or hate the thought of genetic engineering, the age of it is here, and I highly recommend that you watch Unnatural Selection to learn more about it. So far, the show is a bit biased toward the possible benefits of genetic editing, and less focused on the potential negative consequences (as I said, I’m only on episode 2), but it is interesting and insightful and thought-provoking, and I recommend it.

I’m sure there is just as much variety in the floxie community as there is in the community at-large regarding genetic engineering, and I certainly don’t think that my views on the topic are representative of those of the floxie community. However, I do think that my personal views on genetic engineering (and all things medical and science related) have been shaped by my experience with fluoroquinolone toxicity.

Fluoroquinolone toxicity is a man-made problem that has no man-made solutions. Many floxed people feel as if they are guinea pigs in an experiment that they unknowingly signed up for. (The post, “The Experiment: Notes from a Reluctant Lab Rat” by floxie friend Jean LeFebvre describes the feeling of being a “reluctant lab rat” of the medical/pharmaceutical industries.) People suffering from fluoroquinolone toxicity know what it is like to be severely negatively affected by an experiment gone awry. We also know what it’s like to realize that there is no way to undo or reverse the damage that has been done to us. It’s unpleasant, to say the least. As CRSPR-cas9 and other similar gene editing technologies are experimentally used on humans those experiment subjects (i.e. people) will likely suffer from side-effects and unintended consequences until the technology is perfected. As with all experiments, things may go wrong, and people may be caused to suffer or die because of the experiments. I suppose that people suffer and die because of current medical experiments too, but with these gene editing technologies the potential exists for future offspring, entire populations, or ecosystems, to be negatively affected. The thought of subjecting people (and other living beings) to suffering and death because of a genetic experiment gone awry is not something that I feel comfortable with at all.

Getting floxed, and subsequently researching the possible mechanisms through which fluoroquinolones hurt people, also made me realize how little we know about the human body. In “Side Effects and Unintended Consequences of Popular Pharmaceuticals” I wrote:

“The more I learned about the complex interactions occurring in my body, the more I realized that the number of unknown factors is far greater than the number of known factors. I realized that, as much as I wanted easy answers and quick solutions, there were none available. Because of the complexity of the human body, as well as individual differences in both genetics and environment, I doubt that easy answers will ever be available. Any one of the many complex systems within the human body can be studied for a lifetime without knowing everything about it. The multiple systems within our bodies are interconnected, difficult to comprehend, poorly understood and truly amazing. Human life is astoundingly, beautifully, mind-bogglingly complex.”

and

“I know that there are some very smart scientists out there; people who are far more intelligent than I, who have a much better grasp of biochemistry – so why aren’t the dangers of fluoroquinolones more well-known? Why aren’t the side-effects entirely predictable? Why did I have to figure out all of this on my own, without help from the physician who prescribed the medication or the physicians I saw post reaction? Sadly, I have come to believe that most physicians and patients alike don’t want to recognize the complexity of human health; preferring instead to believe in our own intellectual supremacy. And as much as I appreciate the scientists who are doing the work on which I have based my assertions, I don’t think that there is anyone who understands the complex biochemical feedback loops sufficiently to guarantee that there won’t be unintended consequences when disrupting part of the system with a pharmaceutical.”

That post was written several years ago, but I still believe those things – we know practically nothing about the human body. The mechanisms of drugs when they have their preferred effects are hardly known, much less the mechanisms of drugs when adverse-reactions are experienced. The complexity of a human is mind-boggling, and we cannot adequately understand the consequences of CRISPR-cas9 or other gene editing technologies.

Whether we can properly understand the consequences or not, the age of genetic editing is here. The technology is available, and it will be used. I hope that it is largely used responsibly.

Though I’m a cautious person, and the precautionary principle is high on my list of guiding principles, I am intrigued by the possibility that gene editing may have positive consequences for many people – including floxies.

What if Cystic Fibrosis, or Tay-Sachs, or Sickle Cell, or Hemophilia, or any of the other horrible genetic-based diseases can be cured through CRISPR-cas9 gene editing? That would be amazing – and few would argue that it wouldn’t be a proper use of this technology.

For floxies, what if there is a specific genetic marker that makes us susceptible to the horrible constellation of symptoms included in fluoroquinolone toxicity? What if floxies have genes that inhibit collagen production, or genes that make us unable to properly absorb cellular magnesium, or genes that make it more difficult for us to metabolize pharmaceutical drugs, or genes that make us more susceptible to autoimmune diseases? If those genes could be identified, and adjusted through CRISPR-cas9, and that could provide a cure…. well…. that would be incredible too.

I obviously have conflicting thoughts and feelings about genetic editing. There is a lot that could go wrong, and many of the things that could go wrong are far-reaching and astronomically consequential. I am inclined toward caution and saying “no” to attempts to solve far-reaching problems with gene editing (not that anyone is asking me). Too much can go wrong when you try to adjust the genes of an entire species.

But on an individual level, I have a hard time saying that we shouldn’t try to “fix” the genetic problems that are causing people pain and suffering. The technology exists, and if pain and suffering can be alleviated with it, I’m certainly not going to argue against that.

Ready or not, the age of genetic editing is here. Hopefully the technology will be used for good, not evil. We shall see.

*****

 

Reluctantly Going to the Doctor

After getting floxed I developed a significant amount of skepticism toward Western Medicine. I realized the damage that Western Medicine, especially pharmaceuticals, can do, and I stopped believing that doctors can fix many issues. I learned that Western Medicine is really lousy at dealing with multi-symptom chronic illnesses of all types–including the ones that are recognized (like autoimmune diseases)–but especially the ones that are not recognized (like fluoroquinolone toxicity) or ill-defined (like ME/CFS, fibromyalgia, etc.). I saw that there is very little that can be done to help people who have suffered from iatrogenic illness, and that often (though not always, of course) when Western Medicine doctors encounter a patient who has been hurt by a pharmaceutical or medical procedure their response is hostile or ignorant.

With that knowledge, I proceeded to tell myself that I was better off without Western Medicine. Despite my insurer’s pleas, I refused to sign up with a primary care physician (out of laziness and inertia as much as fear and adversity) and I told myself that I was healthier and happier without getting poked, prodded, and possibly poisoned by doctors. For the most part, my avoidance of the Western Medical system has been serving me fine. I have been healthy and happy for many years.

However, I recently had an issue that needed to be fixed by a Western Medicine doctor – or, at least the tools of a Western Medicine doctor. I needed a minor surgery. A scalpel and Novocain were necessary to fix my issue (an issue that is somewhat embarrassing, has nothing to do with fluoroquinolone toxicity, and that no one wants to envision, so I’m going to do my best to get through this post without saying exactly what it was). No diet changes would cure me, nor could acupuncture, nor could exercises, or anything else other than a scalpel (the Novocain wasn’t strictly necessary, but it sure made getting cut easier for everyone involved). So, I went to a surgery center, got my minor surgery, and am on my way to being healed. The doctor who fixed my issue was good. He was kind, thoughtful, and he did what he needed to do to fix my issue in as quick and painless a way as possible. I am grateful to him for what he did, and I’m glad that the technology to quickly and easily fix my issue was available.

Western Medicine is really good at fixing well-defined problems that involve scalpels and other cutting tools. Western Medicine put me back together.

About a week after I got my issue fixed, my mom fell and broke her hip. She needed a partial hip replacement and she got one. It’s still a recent development, and it’s TBD how well she was put back together, but, my point is that Western Medicine doctors are good at dealing with broken bones (and pus pockets). They also have good tools for numbing people and knocking them out. The painkillers that they have are also quite effective (though not without consequence). I’m hopeful, actually fairly confident, that the doctors did a good job putting my mom back together, and that she’ll recover well.

I wish that Western Medicine was as good with multi-symptom, multi-system, complex illnesses as it is with broken bones, pus pockets, and other issues that can be fixed with surgery. I wish that fixing gut microbiome dysbiosis was as common and easy as fixing a broken bone. I wish that hormonal imbalances were as easy to detect and cure as an abscess. I wish that adverse drug reactions were easy to detect, and that the promise in all the commercials of “see your doctor if xyz occurs” resulted in a doctor who knew how to treat and cure adverse drug reactions. But Western Medicine isn’t good with multi-symptom, multi-system, chronic illnesses – it just isn’t.

But they are good with broken bones and surgeries, and I am very, very, very thankful that I got my issue taken care of, and that my mom got a surgery to put her hip back together.

Western Medicine has its place. And as much as I’d like to avoid doctors, I’m going to go to them when necessary. I’m guessing that you will too. I really wish that they were better at treating fluoroquinolone toxicity and other similar issues – or even better at treating the symptoms of fluoroquinolone toxicity. Maybe someday.

*****

 

Deciding Which Treatments to Try

The following is a guest post from Stephanie. If you are interested in writing a guest post for FloxieHope.com, please let me know

*****

I really get bombarded all the time with, “go get stem cells how could you not?” I get so anxiety ridden from it. I know people mean well but it’s so hard on me. It feels like harassment and not love at certain points–like they can’t handle me being sick so I have to heal for them to be okay.

I just want people to know that whatever they do to heal is their own decision.

I’m constantly deciding–how much do I want to be tested on, and what treatments do I want to try?

I’ve been floxed for almost five years and it’s a 5 steps forward and 4 steps backwards dance where I hold onto the one step forward as best I can–because it’s better than the times where it’s 6 steps backwards and I fight just to get back to where I was.

The crazy part is that it all becomes a matter of how much I want to be tested and treated, AND how much I want to pay for it.

There still isn’t enough data to answer one simple question: Will this procedure help me or hurt me?

Because these side effects feel like a bomb went off inside my body that made things crazy, it feels like it’s impossible for any doctor–western or natural–to give me a straight answer of, Will this treatment help or hurt?

People can list out what helps but no one can know for each person. How I look at it is we are all being tested on to get more data and to pay for it.

So, I constantly have to weigh out, do I want to risk what I have for an unknown promise of healing?

That carrot is so tempting and so hard to answer.

For me, I weigh everything on what happens if it goes wrong how much will it mess up my life. How much can I afford this to mess up things?

My husband has medical issues too and he needs to be made to take care of things too.

So, it’s a dance that is never ending.

When people ask me why don’t I try this or that it’s because I don’t like to be poked and prodded and tested like a guinea pig.

I have to feel like the odds are somehow going to be in my favor because I’ve seen various experimental treatments make people so much worse, and I often think that it’s not worth the risk.

It’s easy to talk when it’s not your life and you are not the test bunny.

Why we have to pay for everything is beyond me.

Why we have to constantly be told yes these are side effects and you get to pay to maybe get your health back is beyond me.

So, for anyone out there that is pressuring someone like me to try something, please understand it’s really easy when you are not the one being poked, prodded, and tested–when it’s not your body and your life that may come crashing down if the treatment doesn’t work as-anticipated.

It’s not easy to pick what to do and how much you are willing to spend to go through treatments that haven’t been proven to work for everyone, much less everyone.

*****

JD Scott Speaks Out About Fluoroquinolone Toxicity

JD Scott, an actor and host of several HGTV shows including Great American Country, HGTV.com’s behind the scenes content for the hit series Brother Vs. Brother, Property Brothers: At Home, Brothers Take New Orleans, radio talk show Off Topic with the Scott Brothers and more, recently posted a health update to his Instagram and Facebook pages that notes that he has been struggling with fluoroquinolone toxicity. His post states:

Health Update:

It occurred to me tonight that I hadn’t actually given you an update since first announcing my illness. On the positive side, I’m still feeling better than I did last year or even the beginning of this one.

What we know so far thanks to Dr. Jacobson’s testing is:

1. I had a bad GI infection which has been fixed. (This was just before that original video)

2. Discovered through followers comments that I was exposed to and may have been suffering from fluoroquinolone toxicity (also called “Getting Floxed”). This would account for many of my symptoms and the timing is dead on. P.S. – Avoid ever taking any antibiotics that have “flox” in the name if you can.

3. Also found out last week that I have acute mercury poisoning. My levels are so high the health department got involved. We don’t know at this point how it happened but I am being treated for it and that would explain the some of the issues I’ve been having as well.

So at the end of the day, we have a lot more clarity on what was going on and how to tackle it. I’ve stuck to the diet which limits (almost to zero) gluten, sugar, soy and dairy. I have so many other things I have to take daily for this treatment but I am so grateful to finally have some real answers and direction.

I want to take a moment as well to talk about something important. We found out recently that someone we know very well didn’t believe I was actually sick. All I can say to that is “why”? How can you dare to think you know what someone is going through on the inside? What possible benefit do I get to pretending I’m fighting off this horrible illness and experience? It costs me most of what I have to treat it. For attention? I already had my presence on social media except now it’s harder for me to create content. I miss out on nearly everything that is fun and exciting to me normally. I have to explain myself over and over and over. Every minute of my day is timed out for medications, supplements and specific meals. So for any person out there who thinks someone might be faking a long term sickness (hidden illness), look deep within yourself and really ask why. My life was so wonderful before this began and all I want is to get back to that place.

Once again, I need to thank my functional doctor, Scott Jacobson with Wishing Wellness Medical who is doing amazing things for me but also the fans who helped more than they can know. I literally got some answers from your experiences which I can now help pass on to those still struggling to find a diagnosis. And most of all, to my amazing partner, Annalee Belle who powers through everything to get me better.

JD and his partner Annalee made this video describing his illness –

Annalee also posted this video about how difficult it is to have a loved-one go through a mysterious illness:

My heart goes out to both JD and Annalee. What they are going through is painful and difficult beyond description.

I’m glad that they realize the connection between fluoroquinolones and JDs illness. Hopefully it helps them to know that there is a community of “floxies” and that they are not alone in what they are going through.

It sounds like they have found a good functional medicine doctor who is helping JD to heal. I wish him all the best with his healing journey. I hope that he recovers fully quickly.

I’m glad that JD and Annalee are speaking out about what they are going through. It’s often painful, and sometimes embarrassing and difficult, to talk about mysterious illness and iatrogenic illnesses. People often don’t believe those that are suffering. Famous people aren’t immune from the suffering caused by fluoroquinolones or the disbelief that accompanies a strange illness like fluoroquinolone toxicity. In speaking out about their experience they are helping to spread the word about how dangerous and destructive fluoroquinolone antibiotics can be. Their advocacy is appreciated!

JD mentioned in his health update post that he is also suffering from mercury toxicity. Several “floxies” have noted that their mercury levels were high post-flox, and in the post “Fluoroquinolones and Mercury Poisoning” I go over some of the potential connections between fluoroquinolone toxicity and mercury poisoning, and how fluoroquinolones may trigger mercury release and poisoning.

Thank you to all in the “floxie” community that have reached out to JD and Annalee. I’m sure that they have learned a significant amount about fluoroquinolone toxicity from you.

I hope for a speedy recovery for JD. Fluoroquinolone toxicity is horrifying, for sure. I hope that he finds healing.

*****

A Journey Through Pharmaceutical Induced Illness

The following post was written in 2013 and published on Collective-Evolution. It is still, six years later, my favorite post. It is my heart and soul. It lays bare how lost and devastated I felt after getting floxed by ciprofloxacin. It describes how I felt being knocked down, and how it felt to heal and get stronger.

This post resonated with many people when it was published. In just a couple days it was shared on Facebook more than 1,000 times. I was amazed and flattered that so many people cared about my journey enough to share my story. 

Because of Facebook’s rules, Collective-Evolution posts don’t have the reach that they did back in 2013. I’m re-posting here on Floxie Hope to revive this post. As I said, it’s my favorite. I hope that it resonates with, and helps, you.

*****

When I realized that Cipro was the cause of my body going completely hay-wire (I didn’t know immediately because my reaction was delayed), and I saw stories on the internet of people getting worse and worse indefinitely, and/or living with pain and disability caused by fluoroquinolones, I thought that I had accidentally killed myself. I thought of writing letters to my family and friends to say goodbye, to let them know that I was gone and that I was so, so, so sorry that I had taken those pills.

In some ways, even though I survived, obviously, I think that I should have written those letters (even though they would have scared the crap out of my loved ones and probably gotten me locked in a psych ward). Because I am different now. The old Lisa is gone. I certainly didn’t die in the physical sense, but who I was changed in an instant, with those 6 pills.

Before I got sick, my identity was formed by what I did, thought and felt. I was active and athletic. In the summer of 2010 I hiked the entire 500 mile Colorado Trail. I was a gym-rat. I’d get up at 5:30 so that I could hit the gym before work. I was trying out CrossFit gyms just weeks before I took Cipro. I took pride in being strong; in being healthy, active and fit. My appetites in all areas was larger than most. I loved food and I could pack it away (only keeping my weight in check by being as into exercise as I was into food). I liked to drink and I was good at it. I liked sex and, well, I dunno, I’ll tell you who to ask if you care. :p I had strong opinions on politics and religion and would express them willingly. I liked to travel and I was proud of my travels all over the world – I have seen and done some interesting stuff. I was a voracious reader as a kid but had slowed down a bit as an adult, but I still read The New Yorker regularly. I considered myself to be smart. I considered myself to be a good conversationalist.

All of that went away while I was sick. I could barely walk, I certainly couldn’t go to the gym, and CrossFit is a recipe for torn tendons for a Floxie. I was weak. I lost my energy. Strong is not something anyone would call me. I stopped eating and didn’t care about food in the least – it actually scared me a bit. Sex was approximately the last thing on my mind and I was scared of it too – it can lead to urinary tract infections and urinary tract infections can lead to antibiotics, and that chain reaction had gotten me into the rotten place where I was. My ability to handle alcohol was diminished. Even if I wanted to drink, and I didn’t, I couldn’t drink much and it wasn’t fun any more. I lost my reading comprehension. I lost my memory. I lost my capacity to do many mental tasks, so I couldn’t consider myself to be smart any more. I felt anxious in social situations and I couldn’t seem to find the words to communicate or connect with people, so I certainly wasn’t a good conversationalist.

All of the things that I thought made me who I was, were gone.

But I was still alive. I was still breathing. I wasn’t able to do the things that I thought made me me, but I was still a being, just now I was a being without any of the things that defined me.

So I fought to get those things that defined me back. I took supplement after supplement, hoping that the next one would be the cure that would bring me back. I scoured the internet, looking for the magic cure, whether it be in the form of a diet, a pill, a specialist or a method. Some of the things that I tried were helpful, some were harmful, most were neutral. None of them turned back the hands of time.

I started the spirituality sampler platter. I meditated. It helped immensely. I went to a Mindfulness Based Stress Reduction class. It helped me as well. I went to Buddhism classes and retreats. I read Marianne Williamson’s, “A Return to Love” and went to classes on A Course in Miracles (ACIM). I went to Hippy Dance Class / Rhythm Sanctuary / Hippy Church and felt the healing power of Hippies saying “OM” together and dancing to trance music. I learned about Chakras. I went to a Crystal Bowl concert.

Meditating, Buddhism classes and a course in Miracles all helped me to get to a point where mentally, emotionally and spiritually, I came to terms with my inability to turn back the hands of time. I started to accept what life had brought me. I started to feel okay about the fact that, even though I couldn’t run, I could still walk. Even though my memory and reading comprehension were shot (those scared me so much), I could still work (sort of). Even though I couldn’t do the things that I thought made me me, I could still breathe, love, feel and see beauty and depth in the moment, etc. With meditation, Buddhism and ACIM, I was able to gain patience, compassion, empathy, forgiveness, etc., mainly for myself, but for others as well.

Eventually I got to a place where I started to like who I was post-flox. Even though I wasn’t as physically strong as I used to be, I found out that I was a fighter. I learned that I’m a survivor. Cipro messed with my ability to communicate verbally, but I could still communicate through writing, and I became a writer. I found something that I feel passionate about, something to scream about, and I stopped hating that my world-view had changed and started to appreciate, in a strange way, that I now had a cause to fight for.

Certainly, this mental, emotional and spiritual healing was possible because I was healing physically. I had the benefit of my body cooperating with me and ceasing the downward spiral that it was intent on for a while. But it’s all interconnected. Our emotional, mental and spiritual health is related to our physical health, and vice versa.

Getting better physically was a long, slow process. Most of my issues were central, peripheral and autonomic nervous system issues. Nerves take a while to heal. They just do. Tendons aren’t fast healers either. But the jumps in my identity, the shifts in my psyche, were sudden. Just the other day, my appetite came back. I started to want food again. Dating has more appeal than it used to (I dated through being floxed, it just felt different). As I’ve been writing, I’ve started to feel smart again. I started to feel like ME again – like the old Lisa. Perhaps these changes (changes back) are just part of healing, part of my brain rewiring itself back to how it was for 32 years, but I prefer to think of it in more spiritual terms. As soon as I accepted and appreciated my new self, my old self returned. Life is interesting, strange and funny like that sometimes.

Even though some, maybe most of my old self traits are back, I now realize that all of those things, what I do, what I think and even what I feel, are transient. I am not the same person as I was before I got sick. But you know what? That’s okay. Because I wasn’t the same person as I was just before I got sick 2 years prior to that. We are all constantly evolving and changing. Nothing is permanent, except, perhaps the soul, love, God, whatever you want to call that constant that is in each of us. Sudden, painful changes that are thrust upon us from the outside are lousy ways to change, and they invite some resistance, but I truly did find peace, and even healing, in acceptance of the changes that came and letting go of resistance and fear.

I suppose that anyone who goes through a life-changing or traumatic event goes through what I went through when I got knocked down by Cipro. When you lose your health, your job, a loved one, etc., whenever something changes for the worse in a way that can’t be reversed, there is the tendency to want to claw back to where you were before the trauma happened, because where you were was good and where you are now is bad. It’s natural. But it never works. It’s impossible to turn back time. You can only move on. Part of moving on is acceptance of where you’re at. Acceptance does not mean that what happened is okay in any way shape or form, it doesn’t mean that you’re complacent and it doesn’t mean that you’re going to stay where you are, it just means that you let go of the notion that you can go backward. Moving forward, from where you’re at, can be an amazing, beautiful thing. It in no way means that you stay sick, or stay where you’re at in life. It’s just as impossible to stay where you’re at as it is to move backward, but in order to move on, to go forward, I have found that acceptance of the impossibility of going back, is crucial.

So, I guess that my closing message to anyone who is struggling with the loss of their former self, is to breathe. Cry and grieve for the parts of yourself that have been brutally taken away from you. Then, once you are done with the grief, know that you can’t go backward, accept that you can’t turn back time, and find some ways to move on, to find peace, happiness and healing. It worked for me. I will hope and pray that it will work for you.

******

Floxed Friday – The Rise of Floxie Education

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: 

We’re in Los Angeles, home of the entertainment industry, the most prevalent researcher on Fluoroquinolone Toxicity, nostalgia, and the doctor that floxed me. Ahhh it’s good to be home… and it’s weird to be home.

We’re shooting two very important interview subjects out here and we are very excited about what’s to come. During every interview, we learn something new that we didn’t know before. Did you know that on certain tests that doctors have to take in med school, “Cipro” is the answer to “What do you prescribe for a UTI?”

That was the case back then, but it’s not the case now.

Before diving headfirst into the entertainment industry, I was on track for medical school. I attended a pre-med summer camp for interested high school students in Boston, where I wore pant suits and attended conferences with a coffee in my hand as if I were a full-blown adult.

In college, I took classes on Animal Behavior and Microbiology, auditing Immunology by accident, and making friends along the way.

A lot of these friends, but not all, ended up making it to medical school. I was eternally grateful when they flooded me with facebook messages, skype calls, emails, and texts asking me the details about what happened to me. They were both alarmed and very curious.

Early into med school, they didn’t know much about what to expect, but a few years later, those same people reached out to me again, “just to let me know” that they had just taken an entire lesson on Fluoroquinolone Toxicity Syndrome and that they were told only to prescribe fluoroquinolones in near-death situations.

Naturally, my former academic peers shared my floxed story with their classmates and later, I had messages from other friends in nursing school who learned about FQT/FQAD.

At Chowder Fest this year, a woman made a sly remark about my “intelligence” when I propped the door to the bathroom open with a garbage can and we ended up talking about Fluoroquinolone Toxicity Syndrome just for a girl who was peeing to raise her arm over the stall and scream, “Is that CIPRO?” She learned about it in a Biology class studying for her Bachelor’s Degree.

I know it’s hard to have hope if you’ve been floxed, particularly if you’ve shown no signs of improvement, but there is hope in education. There’s hope in the future.

We hope that once finished, we can use this documentary as an educational resource for doctors and other medical professionals alike. Just talking about it seems to spark awareness and hopefully, change.

Have a great weekend!

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

*****

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.

*****

 

Why All Recovered Floxies Are Only 99% Better

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: 

It’s hard to bounce back from Fluoroquinolone Toxicity Syndrome. In fact, many people never do. For those who do, you may ask, How do you feel? Are you back to normal? Are you at 100%?

I don’t know a single floxie comfortable with saying they are 100% better. I never have. I also don’t think it’s possible to be “back to normal” or to who you were previously when something like this happens to you.

It’s traumatic. It changes your perspectives on life, on the medical system, on what the heck an antibiotic is, on what you put in your body, and the significance of everyday things. How can you ever be back to who you were, especially when you come back from a horrifying disability?

And no, rarely anyone can say they are 100% better because flare ups happen. Some symptoms never go away. Even if you feel good for years, one day you wake up with the worst chest pain in your life and you wonder, “Is this an aortic aneurysm?”

EBV and Nerve Damage:

I felt this way more recently with the onset of Epstein-Barr virus, which affects approximately 90% of the population, commonly known as mononucleosis or “mono,” and going back to a lot of the same supplements I took every day for years when I was at my worst.

I’ve been dealing with numbness in my hands again and it’s horribly frustrating. This came up after taking cacao, a neurostimulant, and it made me wonder, Are my hands getting better or worse?

A thing we floxies say is that “healing comes in waves.” Really. You’ll feel a symptom and it may come and go over the matter of a few days or weeks or months before you start to feel it get better. Maybe my long-time nerve damage in my hands is going through a healing process again thanks to the cacao or maybe it’s getting worse. I’ll never know and there is probably no PhD, no expert on Planet Earth, who has the answer to that question, so I just have to wait it out like everything else.

So for now, my pee is bright yellow all thanks to high levels of b-vitamins in my system, you know, to stimulate nerve healing, mitochondria healing, and all that stuff. Amy Moser mentioned in our interview that it takes about a month for one inch of nerve to heal and that her nerves are forever damaged after 8 years, so she believes.

Who knows?

What’s next for the Floxed Team:

We have awesome news to share.
We’re finally all meeting in Los Angeles to shoot some of our bigger interviews (shh) with some big researchers and medical professionals in the field next month.

I’m very excited since LA was my home when I was floxed and I can’t wait to meet some of these people I’ve only spoken to online or over the phone. I’ll be meeting even more friends/floxie family while we’re out there and this is my first time back home since getting floxed.

We’re also applying to more grants and we feel very positive about them, especially one that particularly focuses on female filmmakers making films about disability awareness (heck yeah we are).

***Wish us luck and please cross all your fingers and toes that we can get some of these grants. It would push the process along much faster***

Have a great weekend!

Best,

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

 

Study Finds That Antibiotics Make Viral Infections More Deadly

New research out of the Francis Crick Institute in London found that antibiotics can worsen viral infections and increase mortality when viral exposure occurs. The research findings published in Cell Reports, “Microbiota-Driven Tonic Interferon Signals in Lung Stromal Cells Protect from Influenza Virus Infection” noted that:

“Our study argues that caution should be exercised when treating patients with antibiotics. Between 2000 and 2015, worldwide antibiotic consumption is believed to have increased by 65%, much of which may be linked to inappropriate treatment of pollution- and viral-based illnesses (Klein et al., 2018). Our results suggest that inappropriate use of oral antibiotics could predispose patients to more severe influenza, because of reduced antiviral resistance of the epithelia.” (source)

When mice with healthy gut bacteria were infected with the flu, approximately 80% of them survived. However, only a third survived if they were given antibiotics before being infected.

The researchers found that antibiotics increase the vulnerability of the lungs to flu viruses, leading to worse infections and symptoms. They found that the reason for the increase in severity of flu virus symptoms was because signals from gut bacteria helped to prepare the lining of the lungs for the viral infection, and made the viral infection less potent and deadly. When antibiotics wipe out the gut bacteria, they don’t signal for the lung linings to prepare for, and fight, the oncoming flu virus, and the virus is able to multiply and proliferate in the unprepared lung linings.

One of the study’s authors, Dr. Andreas Wack, stated:

“We were surprised to discover that the cells lining the lung, rather than immune cells, were responsible for early flu resistance induced by microbiota. Previous studies have focused on immune cells, but we found that the lining cells are more important for the crucial early stages of infection. They are the only place that the virus can multiply, so they are the key battleground in the fight against flu. Gut bacteria send a signal that keeps the cells lining the lung prepared, preventing the virus from multiplying so quickly.”

Gut bacteria are crucial for cell signaling, and both healthy gut bacteria and proper cell signaling are necessary for the body to mount a proper response to viral infections.

My primary response to this study is a desire to show it to everyone I know that insists on getting a prescription for antibiotics whenever he/she has the sniffles. DON’T TAKE ANTIBIOTICS FOR VIRAL INFECTIONS! They’re not only useless, they’re harmful. And they’re not only harmful because of their side-effects and because they encourage antibiotic resistance, they’re also harmful because disruption of the gut microbiome disrupts cell signaling and the ability of the body to prepare for the viral attack.

My secondary response is to wonder what the specific effect of fluoroquinolone antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and a few others) is on cell signaling and our ability to fight viral infections. “Microbiota-Driven Tonic Interferon Signals in Lung Stromal Cells Protect from Influenza Virus Infection” isn’t about fluoroquinolones in any way other than peripherally – because fluoroquinolones are antibiotics. However, there have been some recent articles about how fluoroquinolones negatively affect cellular signaling. The study, “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” published in Nature, found that, “ciprofloxacin induced the release of both DNA (mitochondrial and chromosomal sequences) and DNA-binding proteins on the exofacial surfaces of small extracellular vesicles referred to in this paper as exosomes.” Exosomes are cell signaling molecules, and fluoroquinolones release DNA from them.

I honestly don’t have a hypothesis connecting these two studies, but I do wonder if there are connections. Are all antibiotics inhibiting cellular signaling? Are fluoroquinolones in particular inhibiting cellular signaling? What are the consequences? I am not sure at this point, but if you want to look into these possibilities, more information about FQs and cellular signaling can be found in the post, “Ciprofloxacin Depletes Exosomal DNA” and in “Nature’s Quinolones: The 4Qs” on FluoroquinoloneThyroid.com.

Antibiotics are consequential in ways that weren’t anticipated a decade or two ago. The links between microbial health and immune health are recent discoveries. The study “Microbiota-Driven Tonic Interferon Signals in Lung Stromal Cells Protect from Influenza Virus Infection” shows us that antibiotics actually make viral infections worse. Antibiotics are not benign drugs. They have severe side-effects (as described throughout this site, and to call them simply “side-effects” is an unfortunate understatement), and as discoveries about the importance of balance, health, and diversity of our microbial communities is uncovered, the full breadth of the damage done by these drugs is being uncovered. I’m not saying that they don’t have their place – they do – but they are consequential, and we should fully weigh the consequences before taking any antibiotics.

Sources:

Cell Reports, “Microbiota-Driven Tonic Interferon Signals in Lung Stromal Cells Protect from Influenza Virus Infection

The Independent, “Antibiotics increase chances of mild flu turning deadly, study suggests: The findings show that animals are less likely to survive as the treatment can wipe out gut bacteria

Science Daily, “Antibiotics weaken flu defenses in the lung

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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’

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Floxed Friday – Oculomucocutaneous Syndrome

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: 
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Oculomucocutaneous Syndrome

I was transferring footage from one drive to another and scrolling through Instagram when I realized that I could use my time in much better ways, so I picked up Ben Goldacre’s ‘Bad Pharma.’

I’ve been reading this book on-and-off since I started making ‘Floxed’ at another floxie’s recommendation. Dr. Ben Goldacre has produced Ted Talksand traveled around the world explaining to the public how and why large pharmaceutical companies can trick doctors with marketing tactics, but also how doctors can mess up… and how that’s normal… and sometimes, yeah, sometimes it’s deadly. Whoops.

Dr. Goldacre started this journey after he misprescribed drugs to one of his patients and hurt his patient even though he followed the information he received about that drug to a tee. How could he, upon following all the Good Doctor rules, hurt his patient?

This topic is long, confusing, and it’s understandably arduous to research and understand it all. Goldacre has written multiple books on what he has learned in his research and I’ve only gotten through the first part of ‘Bad Pharma,’ which is 100 pages long and currently chock full of highlights, underlines, and various annotations.

This particular thing caught my eye just now: Oculomucocuaneous Syndrome. This particular syndrome isn’t just an illness that comes on randomly nor is it a virus or some kind of disease. No, it’s actually what Goldacre describes as a “horrific” multi-system side effect of the drug ‘practolol.’

Practolol was a beta-blocker drug used for heart problems that had a side effect in humans which didn’t occur for the animals they tested on first, which apparently occurs very rarely. So, what is Oculomucocuaneous Syndrome? He left it at “horrific,” so I had to find out.

No, it’s nothing like Fluoroquinolone Toxicity Syndrome other than the multi-system syndrome inducing part. It consists of keratocunjunctivitis sicca, which is dry eye syndrome. The Wikipedia article showed a picture of someone with blue sclera, but it’s actually just a dye they used, so it seemed more horrifying than it actually is. It also consists of various scarring and something called metaplasia, which is the transformation of one type of cell into another type of cell (WOW what), and the shrinking of a different part of the eye.

According to this PubMed article about the syndrome, 3 patients had significant vision lost and many also lost their ability to produce tears. So that is definitely horrifying, but Fluoroquinolone Toxicity Syndrome is just as if not more horrifying, so why wasn’t it immediately pulled off the market like Practolol?

If you’re interested in how scientific studies and drugs work, I highly recommend grabbing a Ben Goldacre book from your local library. These books are very dense, but they’re an interesting read.

Have a great weekend!

Best,

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

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Writer’s Block, Advocacy Works, Getting Stronger, and Rivers Full of Antibiotics

I am having horrible writer’s block, and I haven’t thought of a thing to write for floxiehope.com in a while. I apologize for the neglect, but I’m really struggling with finding the time, energy, and motivation to write about this very important topic.

This post consists of the few FQ-related thoughts that have been running through my brain lately, but it’s not a very fluid or comprehensive post, and I apologize for that.

If you are interested in helping me to keep this site active and relevant by writing a guest-post, I would greatly appreciate your help! Here is a link with info about writing for Floxie Hope:

https://floxiehope.com/2017/12/07/write-for-floxie-hope/

If you have topic requests that you would like me to write about, I am open to suggestions. Please don’t hesitate to contact me.

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I have been meaning to write a post about the recent finding that most of the planet’s rivers are polluted with antibiotics. This is a topic that deserves its own post, but I haven’t gotten around to it yet. Anyhow, here are some articles about this awful travesty:

  1. The Guardian, “World’s rivers ‘awash with dangerous levels of antibiotics: Largest global study finds the drugs in two-thirds of test sites in 72 countries
  2. CNN, “The world’s rivers are contaminated with antibiotics, new study shows
  3. National Geographic, “First global look finds most rivers awash with antibiotics: Almost two-thirds of the rivers studied contained enough antibiotics to contribute to the growing problem of antibiotic-resistant bacteria.

Nothing about this is okay. Rivers have microbial communities that need to be alive for the health of the river and all the life within it. Killing bacteria throughout a river ecosystem is wrongheaded and likely horribly consequential for all the life in the river. As people ingest the water from the river, they are getting dosed with antibiotics, some of which are fluoroquinolones, and thus increasing their risk of suffering from fluoroquinolone toxicity and other adverse-reactions to antibiotics. Constant low-level ingestion of antibiotics is horrible for the human microbiome too, and microbiome destruction and imbalance is linked to many diseases. And, of course, low-level constant dosing of antibiotics leads to antibiotic resistance (the main problem that these articles focused on). It’s awful and tragic and depressing.

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On a happier note:

I went on a hike this weekend with my Dad and a couple of his friends. One of his friends mentioned that her 90-year-old father was saved from getting floxed because she was aware of the dangers of fluoroquinolones and told the doctors in no uncertain terms that they were not to give her elderly father these dangerous drugs. She was aware of the dangers of fluoroquinolones because of my advocacy efforts, and it felt really good to hear that from her. We know each other through my dad, not through any of my patient-advocacy work. Still, she heard and she listened, and she kept her father away from these dangerous drugs. One person at a time – the word is getting out and people are listening. Keep posting about the dangers of fluoroquinolones. Keep screaming about the damage these drugs have done to you or your loved ones. People are listening.

Here are some posts on both spreading the word about fluoroquinolone toxicity, and people listening:

  1. Friends Don’t Let Friends Take Fluoroquinolones: Four Stories
  2. Keep Banging That Drum

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I have been hiking a lot lately. Though I have been on dozens of hikes post-flox, something has shifted recently. I am strong again, and I’m capable of getting stronger quickly. Strong and capable of building muscle easily and quickly was how I described myself before I got floxed. Cipro made me feel weak and incapable, and I certainly didn’t describe myself as strong post-flox. After I recovered from the acute phase, I could move and exercise moderately, but I never felt like I was increasing my capacity or getting stronger. Lately, I have returned to feeling strong. I went on two pretty intense hikes this weekend (both about 5 miles, with a significant amount of elevation gain), and I felt strong during and after both of them. I have been doing after-work 50-minute hikes lately that have been getting easier and easier. It feels really good to not only be capable, but to be strong and fit. I didn’t feel that way for a very long time.

As always, I mention these gains not to brag or to make light of the horror of fluoroquinolone toxicity, but in hope that my recovery gives you hope for your recovery.

Love and hope for recovery for all of you!

Hugs,

Lisa

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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.

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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 Tragic Loss of Rachel Held Evans

Christian author Rachel Held Evans in 2018. (Dan Evans)

Many people in the “floxie” community have been sharing the tragic news of the death of Rachel Held Evans.

Rachel Held Evans was a popular Christian author, blogger, and speaker. She lived a significant and impactful life in the 37 years that she was alive. She was a wife to Dan Evans, and the mother of two children. Dan said of Rachel:

“She put others before herself,” her husband, Dan Evans, said in an email on Saturday. “She shared her platform. She always remembered how others had helped her. She enjoyed seeing other people in contexts where they thrived. She didn’t hold grudges, would forget as well as forgive. She had little time for pettiness and a big heart for people. And these are all things I wish I had told her more while I still had the privilege to keep her company.” (source)

There are lovely obituaries and tributes to Rachel Held Evans in many publications. Here are a couple:

Rachel Held Evans experienced an adverse reaction to an antibiotic before her death, and that adverse reaction, along with UTI and flu symptoms, are what led her to check into the hospital on April 14, 2019. On May 4, 2019, she had passed after experiencing brain-swelling, seizures, and a medically-induced coma.

Many people have asked if the antibiotic that Rachel Held Evans had a “severe allergic reaction” to was a fluoroquinolone. It is reasonable to think that the antibiotic she reacted to may have been a fluoroquinolone – fluoroquinolones are often used to treat UTIs. However, I have not seen any confirmation that Held Evans was given a fluoroquinolone. It’s possible that she was “floxed,” but it’s also possible that she reacted horribly to another antibiotic. We don’t know at this time. Perhaps her family will update her story with information about what antibiotic she reacted badly to at some time in the future. At this point, the health updates from Dan Evans don’t give specific information about the antibiotic that contributed to her illness.

What is known about Held Evans’ illness and death is summarized well in the Washington Post article, “What we know about the death of popular Christian writer Rachel Held Evans.”

We don’t know what caused her health to decline so rapidly, or what kind of antibiotic she reacted badly to. We don’t know what caused her seizures, or what happened in the hospital. We don’t know what genetic (or other) predispositions she had toward adverse drug reactions, seizures, or anything else. We don’t really know why a 37 year old woman who was healthy less than a month ago is now dead.

We do know that when she entered the hospital she was well enough to tweet and to express concern about missing the newest episode of Game of Thrones (GOT), and that while in the hospital she started to experience seizures and brain swelling. We know that the seizures and brain-swelling led to her death.

We also know that fluoroquinolones can trigger seizures. Per the FDA warning label for CIPRO:

“CIPRO, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. As with all fluoroquinolones, use CIPRO with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction). Use CIPRO when the benefits of treatment exceed the risks, since these patients are endangered because of possible undesirable CNS side effects. Cases of status epilepticus have been reported. If seizures occur, discontinue CIPRO.” (source)

But, again, we don’t know whether Rachel Held Evans took Cipro, or any other fluoroquinolone antibiotics. And we certainly don’t know whether or not fluoroquinolones caused her seizures.

We do know that the death of Rachel Held Evans is tragic, and that she will be missed by thousands (possibly millions) of people whose lives she touched. Hearts around the world are aching for her husband, children, and all others who loved her.

Considering her decline while in the hospital, I think it’s also reasonable to assume that her death was iatrogenic (caused by a medication or medical treatment). If this assumption, and questions around it, give the loved-ones of Rachel Held Evans some peace and closure, I hope that they get both answers and some form of justice.

It is clear that Rachel Held Evans was an amazing person who lived a generous, thoughtful, connected, beautiful life. It is a heartbreaking shame that she died so young and under such shocking and difficult circumstances.

My sincere condolences to her family and loved-ones.

*****

 

Ciprofloxacin Depletes Exosomal DNA

Journal of Extracellular Vesicles, “Biological properties of extracellular vesicles and their physiological functions”

The study, “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” published in Nature, found that, “ciprofloxacin induced the release of both DNA (mitochondrial and chromosomal sequences) and DNA-binding proteins on the exofacial surfaces of small extracellular vesicles referred to in this paper as exosomes.” And, “Our results reveal for the first time that prolonged low-dose ciprofloxacin exposure leads to the release of DNA associated with the external surface of exosomes.”

In the discussion section of “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” the authors expand on their findings:

“Exposure of Jurkat cells to ciprofloxacin has been shown to induce oxidative stress, production of reactive oxygen species, mitochondrial dysfunction, inhibition of the respiratory chain and decrease of mitochondrial membrane potential leading to mitophagy47. Our MS analysis has also confirmed the above biological processes in Jurkat cells. Importantly, the presence of ciprofloxacin has been reported to lead to the loss of mtDNA28, 29 and an aneuploidy caused by the genotoxic stress of Jurkat cells30, 48. Genotoxic stress response has been shown to induce the release of nucleosomes by leukemic myeloid cells49. In the present study, mitochondrial damage of ciprofloxacin-exposed Jurkat cells has been evidenced by the abundance of mtDNA, and the nucleoid protein FEN1, as well as numerous other mitochondrial proteins in the secreted vesicles. Ciprofloxacin inhibits both the bacterial DNA gyrase and the mammalian topoisomerase II enzymes responsible for proper DNA replication50. Given that ciprofloxacin mainly inhibits the mitochondrial isoform of mammalian topoisomerase II29, its presence induces mtDNA fragmentation as well as subsequent gradual decrease in mtDNA content29.”

And also note that:

“We found that the exosomal DNA release-inducing effect was not solely observed in the case of Jurkat cells as we also detected ciprofloxacin-induced release of exofacial EV DNA in the case of the pancreatic cancer cell line MiaPaCa. These results demonstrate that DNA-associated EVs may be released from various types of cells after long-term ciprofloxacin exposure.”

These findings are interesting, and I think consequential and explanatory.

But, I am guessing that most people reading this need some more information about what the excerpts above mean. I know I did (and I had to read it about five times).

First, understanding “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” requires a little knowledge of what extracellular vesicles and exosomes are.

Extracellular vesicles (EVs) are “lipid bilayer-delimited particles that are naturally released from a cell and, unlike a cell, cannot replicate. EVs range in diameter from near the size of the smallest physically possible unilamellar liposome (around 20-30 nanometers) to as large as 10 microns or more, although the vast majority of EVs are smaller than 200 nm. They carry a cargo of proteins, nucleic acids, lipids, metabolites, and even organelles from the parent cell. Most cells that have been studied to date are thought to release EVs, including some bacterial, fungal, and plant cells that are surrounded by cell walls. A wide variety of EV subtypes have been proposed, defined variously by size, biogenesis pathway, cargo, cellular source, and function, leading to a historically heterogenous nomenclature including terms like exosomes and ectosomes.” (Source)

Exosomes are a subtype of extracellular vesicles. “Exosomes are best defined as extracellular vesicles that are released from cells upon fusion of an intermediate endocytic compartment, the multivesicular body (MVB), with the plasma membrane.” (Source) More information (that’s only basic if you have a heavy science background) about exosomes can be found in “Q&A: What are exosomes, exactly?

Basically, they’re molecules secreted from cells that affect other cells (sometimes positively, sometimes negatively).

Here’s a series of videos that give a really high-level, shiny and high-production-value explanation of exosomes and extracellular vesicles:

Additionally, here are some interesting tidbits about extracellular vesicles (EVs) and exosomes gathered from various articles:

“In the past decade, extracellular vesicles (EVs) have been recognized as potent vehicles of intercellular communication, both in prokaryotes and eukaryotes. This is due to their capacity to transfer proteins, lipids and nucleic acids, thereby influencing various physiological and pathological functions of both recipient and parent cells. While intensive investigation has targeted the role of EVs in different pathological processes, for example, in cancer and autoimmune diseases, the EV-mediated maintenance of homeostasis and the regulation of physiological functions have remained less explored.” (Source)

“EVs alone regulated the expression of numerous genes related to inflammation and signaling.” (Source)

“EVs are carriers of pathogen-associated and damage-associated molecular patterns, cytokines, autoantigens and tissue-degrading enzymes. In addition to a possible role in the pathogenesis of a number of inflammatory conditions, such as infections and autoimmune diseases, EVs, including microvesicles (also known as microparticles), exosomes and apoptotic vesicles, have therapeutic potential and might be used as biomarkers for inflammatory diseases.” (Source)

“another significant role of EVs has emerged in the removal of unwanted molecular material as a means for cell maintenance.” (Source)

“This report is the first show that numbers of blood-derived EVs are elevated in patients suffering from CFS/ME, indicating their potential involvement in disease pathogenesis. This promising finding may not only provide insights into the mechanisms involved in the disease but also shows that EVs may be useful for early diagnosis of illness. Moreover, isolation of circulating EVs coupled to our prototype for their detection by LFIA may constitute a powerful diagnostic tool, which can be performed in a single step and in minutes. We concluded that EVs may play a critical role in CFS/ME. Studies with larger sample size, outcome measures and different study designs (i.e. cross-sectional vs. longitudinal cohorts) are now urgently needed. These studies should stratify subgroups according to illness onset and progression, and assess patients at baseline and following induction of post-exertional malaise (PEM), using the 2-day cardiopulmonary exercise test (CPET).” (Source)

“Mast cells, being capable of both degranulation and subsequent recovery, have recently attracted substantial attention as also being rich sources of secreted extracellular vesicles (including exosomes and microvesicles).” (Source)

Both extracellular vesicles and exosomes contribute to processes that are related to many illnesses (including multi-symptom chronic illnesses like ME/CFS and autoimmune diseases, as well as cancer), as well as some of the processes behind those diseases such as inflammation, mast cell activation, cellular signaling and communication, etc. Neither extracellular vessicles nor exosomes are bad though – they are neither good nor bad. They are a natural function, and their relationship to these disease processes may be to spread the disease or prevent the disease, depending on many more factors than I can even begin to fathom.

I surmise and assume though, that removal and depletion of DNA from exosomes, is not a healthy or productive thing to do. And as this study showed, ciprofloxacin, and probably other fluoroquinolones, remove/deplete DNA from exosomes.

Can the removal of DNA from exosomes trigger inflammation? Can the depletion of DNA from exosomes change the inter-cellular communication in ways that trigger illnesses? Extracellular vesicles and exosomes are involved with the immune system, so can depletion of DNA from exosomes trigger immune dysregulation or autoimmune diseases? In depleting DNA from exosomes, does ciprofloxacin trigger disease? We know that ciprofloxacin can trigger multi-symptom chronic illness – is the depletion of exosomal DNA the mechanism through which it “floxes” people?

I don’t know the answers to those questions, and I doubt that the scientists who know much more about cellular processes than I do know those answers either. But “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” raises some really interesting questions, and provides some interesting and insightful links for those of us who are exploring what occurs in the body of a “floxed” person.

Sources*:

Nature, “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA

BMC Biology, “Q&A: What are exosomes, exactly?

Journal of Extracellular Vesicles, “Biological properties of extracellular vesicles and their physiological functions

Cellular and Molecular Life Sciences, “Critical role of extracellular vesicles in modulating the cellular effects of cytokines.

Nature Reviews. Rheumatology., “Emerging role of extracellular vesicles in inflammatory diseases.

Journal of Extracellular Vesicles, “Circulating extracellular vesicles as potential biomarkers in chronic fatigue syndrome/myalgic encephalomyelitis: an exploratory pilot study

Seminars in Cell and Developmental Biology, “Mast cell secretome: Soluble and vesicular components.

*I found these sources through the post “Nature’s Quinolones: The 4Qs” on FluoroquinoloneThyroid.com – you should check it out – it’s great.

*****

 

 

 

EMA Final Decision re Fluoroquinolones

The European Medicines Agency (EMA) released their final decision regarding fluoroquinolones. You can read the EMA verdict in “Quinolone- and fluoroquinolone-containing medicinal products” and “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” (both from the EMA web site). Additional information can be found on the UK Government web site in the article, “Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects.” Changes to European fluoroquinolone labels can be viewed HERE.

From the EMA:

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.

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.

Please excuse me for not knowing exactly how European drug regulation works (and please correct me if I am wrong), but it looks like the EMA makes recommendations, then the various European governments pass down instructions to their citizens.

The UK government web site gave the following recommendations to healthcare providers:

Advice for healthcare professionals:

  • systemic (by mouth, injection, or inhalation) fluoroquinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses
  • advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice – sheet for patients

do not prescribe fluoroquinolones:

  • for non-severe or self-limiting infections, or non-bacterial conditions

  • for some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease; please refer to revised indications in the Summary of Product Characteristics) unless other antibiotics that are commonly recommended for these infections are considered inappropriate (see below)

  • ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below)avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic

  • prescribe with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants because they are at a higher risk of tendon injury avoid use of a corticosteroid with a fluoroquinolone since co-administration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture

  • report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store)

I hate that they put “very rarely” into these warnings, seeing as adverse reactions to fluoroquinolones are woefully under-studied and the assertion that these effects are “rare” is based on assumption rather than fact. BUT, these prescriber guidelines, along with the EMA guidelines, are steps in the right direction, and hopefully they will cut unnecessary fluoroquinolone prescriptions significantly.

Here are a few notes about the proposed changes to the European Fluoroquinolone Warning Labels:

  1. It is recommended that fluoroquinolone use be restricted for uncomplicated cystitis, Acute exacerbation of chronic bronchitis and of chronic obstructive pulmonary disease, Acute bacterial rhinosinusitis, and Otitis media acute.
  2. The warning labels are still leaving a lot of discretion to doctors/prescribers, and state, “In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.” even though other parts of the warning label note that FQs should not be used for that particular indication. I worry that this may lead to some confusion among doctors/prescribers.
  3. The new warning label notes that people who have experienced adverse reactions to fluoroquinolones in the past should not take fluoroquinolones. “The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with [INN] should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment.”
  4. The possibility of prolonged, serious, and disabling side effects of fluoroquinolones are noted. “Prolonged, disabling and potentially irreversible serious adverse drug reactions
    Very rare cases of prolonged (continuing months or years), disabling and potentially
    irreversible serious adverse drug reactions affecting different, sometimes multiple, body
    systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients
    receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk
    factors. [INN] should be discontinued immediately at the first signs or symptoms of any
    serious adverse reaction and patients should be advised to contact their prescriber for
    advice.”
  5. I’m slightly shocked that the risk of tendon problems is just-now being added to European warning labels, but it is one of the changes noted. “Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with [INN] should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.”
  6. Warnings about peripheral neuropathy are also added. “Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with [INN] should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition.”
  7. Permanently disabling effects are noted again, “*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors.”
  8. Disappointingly, the “Package leaflet: Information for the patient” is full of the words “very rarely” when referring to all the potential effects of fluoroquinolones. Again, the exact rate of adverse reactions to fluoroquinolones is unknown (and may be unknowable because of delayed adverse reactions), and I think that it’s a dis-service to patients to downplay the possibility of these serious and severe effects of fluoroquinolones.

THANK YOU, THANK YOU, THANK YOU to all the European advocates that pushed for these changes in fluoroquinolone warnings and prescribing. You have made an enormous difference, and hopefully rates of fluoroquinolone prescriptions will decrease significantly because of your advocacy.

*****

Levofloxacin and Azithromycin Both Cause Heart Rhythm Abnormalities

The CBS News article, “FDA warns azithromycin “Z-pack” antibiotics could lead to deadly heart rhythms for some” has been circulating around Facebook lately. The article is from 2013, but it is still relevant today, and I am glad to see that people are spreading the word about the dangers and consequences of all antibiotics.

However, whenever I see the article posted, I want to scream – Levaquin/levofloxacin is just as bad, if not worse, for heart health, than azithromycin/Z-packs. 

The article in Annals of Family Medicine, “Azithromycin and Levofloxacin Use and Increased Risk of Cardiac Arrhythmia and Death” concluded that:

“Compared with amoxicillin, azithromycin resulted in a statistically significant increase in mortality and arrhythmia risks on days 1 to 5, but not 6 to 10. Levofloxacin, which was predominantly dispensed for a minimum of 10 days, resulted in an increased risk throughout the 10-day period.”

The article elaborates:

“In this nationwide cohort study of US veterans, compared with amoxicillin, we found that a short-course of azithromycin therapy was associated with statistically significant hazard ratios of 1.47 for mortality risks and 1.77 serious arrhythmias risks within the first 5 days of treatment. The risk of these events was not significantly increased for days 6 to 10. Treatment with levofloxacin, also when compared with amoxicillin, had statistically significant hazard ratios of 2.49 for mortality risk and 2.43 for serious arrhythmia risk; however, the increased risk with levofloxacin continued to be statistically significant during days 6 to 10.”

Both azithromycin/Z-packs and Levofloxacin are more dangerous than amoxicillin. But Levofloxacin is more dangerous to the heart for a longer period of time.

The warning label for fluoroquinolones elaborate on the arrhythmia risk:

“Some fluoroquinolones, including LEVAQUIN®, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including LEVAQUIN® . LEVAQUIN® should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.”

Additionally, fluoroquinolones increase the risk of aortic ruptures and tears. The FDA added warnings about aortic tears and ruptures to fluoroquinolone warning labels in 2018 – “FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients.”

People should be aware of the increased risk of heart rhythm irregularities with azithromycin/Z-packs. They should know that azithromycin prescriptions can have deadly consequences. People should also know that fluoroquinolones, Levofloxacin in particular, is NOT a safer alternative. In fact, it’s even more dangerous than azithromycin, and it not only causes deadly heart-rhythm irregularities, it also damages blood vessels.

People with pre-existing heart-rhythm irregularities should avoid both azithromycin and levofloxacin (as well as the other fluoroquinolones).

Doctors and patients alike should be aware of these risks to heart and vascular health that are associated with antibiotic use. A decade ago it would have been considered unthinkable that antibiotics could be linked to heart and vascular problems. But the research has shown that these connections exist.

Be careful, my friends. And spread the word about all dangerous antibiotics.

*****

Floxie Hope Podcast Episodes 27 & 28 – Dawn

Dawn shares her journey through fluoroquinolone toxicity on episodes 27 and 28 of The Floxie Hope Podcast.

Both podcasts can be downloaded through iTunes as well: https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Dawn suffered from severe depression, suicidal ideation, and dark thoughts that made her fear for her life. I hope that her story helps others who are going through this to know that they are not alone.

A couple of compounding issues that Dawn had were benzodiazepine withdrawal and breast implant illness. If anyone is suffering from those issues too, Dawn’s story will likely resonate with them too.

Please accept my apologies for both splitting Dawn’s story into two podcast episodes, and for the poor sound quality. My computer that I knew how to produce podcasts on died, and I’m having some issues with my new computer. Thank you for your patience, and for listening to Dawn’s episodes of the podcast despite the poor production quality.

*****

Fluoroquinolone Toxicity News in South Africa – Carte Blanche

I encourage you all to watch, and share, the WONDERFUL news story from Carte Blanche, a South African investigative journalism television series, about the dangers of fluoroquinolones. It’s one of the best pieces of journalism I have seen regarding fluoroquinolone adverse-effects. You can view the story through the Carte Blanche web site, or through Youtube:

Carte Blanche Web Site, “Antibiotic Alert”

Video Link

Carte Blanche tells the stories of pain brought on by fluoroquinolones for three South African “floxies,” Tracy Witelson, Gerald Ludwinsky, and Debbi Kinrade. Their stories are powerful and poignant, and they thoroughly describe the horror of fluoroquinolone toxicity.

The Carte Blanche journalist that interviews the victims of fluoroquinolones, as well as Bayer representatives and representatives of the South African Health Products Regulatory Authority (SAHPRA), does a WONDERFUL job of compassionately framing the stories of the victims, and pushing the pharmaceutical and SAHPRA representatives by asking them tough questions, challenging them, and doing what he can to hold them accountable for the harm done by fluoroquinolones.

In an exchange that is simply wonderful, journalist Derek Watts goes over the newly (2016-2018) highlighted warnings included on the FDA warning labels for fluoroquinolones (including a warning that notes that fluoroquinolones can cause permanent disability, one that notes that the risks of fluoroquinolone use outweigh the benefits, one that notes that fluoroquinolones cause blood-sugar irregularities and mental health adverse-effects, and one that notes that fluoroquinolones increase the risk of aortic aneurysm and dissection) with Dr. Naren Jairam, the Bayer Pharmaceuticals representative. Dr. Jairam dismissively asserts that these warnings are nothing new. Watts responds by asking Jairam why Bayer hasn’t been communicating the dangers of fluoroquinolones with doctors (much less patients). Jairam claims that Bayer supports responsible use of antibiotics and that Bayer has advocated that fluoroquinolones not be used as first-line antibiotics. Watts CALLS HIM OUT and says, “That’s not true,” and notes that millions of prescriptions for non-life-threatening infections are being given all over the world. It is truly wonderful to see a quick-witted journalist asking tough questions of pharmaceutical company representatives, and calling them out when they lie and mislead.

In another exchange, Watts asks Jairam, “Is your intention to obfuscate or clarify?” VERY good question – thank you for having the chutzpah to ask, Mr. Watts!

Watts also confronts Eric Chauke, Bayer’s Head of Regulatory Affairs, by asking him to show that Bayer is communicating the risk of harm by fluoroquinolones with doctors. Chauke shows Watts some general pamphlets on antibiotic stewardship, and Watts pushes back – noting that there is nothing in what Chauke is showing him that adequately communicates that fluoroquinolones can have “dreadful side-effects” or that adequately communicates that fluoroquinolones should not be used as first-line antibiotics.

Watts also asks Professor Marc Blockman, a representative of the South African Health Products Regulatory Authority (SAHPRA), some tough questions. He asks whether or not the SAHPRA warnings are adequate, and why SAHPRA can’t send a communication to doctors stating, “don’t prescribe these drugs unless it’s life threatening and there is no alternative?” Patient advocates have been asking the same thing for years, and it’s nice to hear a journalist ask this question to a drug regulator.

I love how tough Watts is on the Bayer and SAHPRA representatives. He is doing a wonderful job at being a journalist that brings to light stories of victims, and holding those in-power responsible for their role in victimizing people.

Please watch and share the Carte Blanche piece on fluoroquinolones. It’s wonderful, and it would be great for it to be internationally “viral.”

*****

 

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.

*****

The Loss of a Loved Community Member

The “floxie” community lost a wonderful person last week. His name is Marc Thavenot, and Levaquin killed him. Marc struggled with fluoroquinolone toxicity for three years. He fought for his life every day of those three years. However, in November 2018 he lost his battle.

Officially, his cause of death was suicide. But the truth of his situation is much more complicated than the simple label of “suicide.” I suppose that all suicides have more to them than simply someone taking his or her own life. There is always a back-story.

Marc’s back-story is that he was tortured by a combination of fluoroquinolone toxicity (Levaquin), benzodiazepine damage, and Lyme Disease. On his web site he described his situation:

“In October 2015 after I had a fall and broke my hand i was put on a drug called Valium which is a benzodiazepine for anxiety and insomnia. Then 3 weeks later I was given an antibiotic called Levaquin for what the doctor thought was a stubborn ear infection. Little did I know that not only are these two drugs dangerous by themselves but are contraindicated when given together and risk for toxicity goes up tremendously. Upon taking the second dose of Levaquin, day number 2, I awoke at 4am with the most terrifying symptoms one can imagine. I felt the most horrific impeding doom, burning all over, ringing in my ears, blurry vision, panic, anxiety and fear unlike anything i could have ever imagine. For the next couple weeks these symptoms persisted along with the most brutal insomnia one can imagine with no sleep for days on end. Having already been dealing with having Cerebral Palsy my entire life this was just life shattering yet I had no idea what was yet to come. A couple months of this and things began to get worse with hallucinations, blood pressure spikes, body temperature deregulation, bone pain, shortness of breath, adrenal crashes, immune system crashing, GI problems, food sensitivities, rashes, teeth pain. It was just absolute hell everyday and i was completely unable to function and no doctor could figure out what was wrong.”

For three years Marc dealt with these issues and more. One of the more devastating symptoms that Marc dealt with was tinnitus that ruined his ability to do his job as a music producer and sound engineer.

Marc tried many things that he hoped would help his situation. Tragically, none of the things he tried cured his fluoroquinolone toxicity, benzodiazepine damage, or Lyme disease.

Perhaps with more time some of his symptoms would have faded, or maybe a cure for fluoroquinolone toxicity, benzodiazepine damage, or Lyme disease would have been found. Perhaps the thing that would have helped Marc to turn a corner toward healing would have come in a few more months, or a few more years. Tragically, we won’t know if solutions would have come to Marc. His time here is over, and that is so, so, so horribly sad.

Like many, maybe most, people, I struggle to find the right words to say both to a person who is suicidal and about a person who has committed suicide. I am not equipped emotionally, nor do I have the right training professionally, to say the “right” things to/about people who are suicidal. So, I have steered away from the topic, and suggested that people reach out to suicide prevention hotlines and mental health professionals. I still suggest both of those things. The National Suicide Prevention Hotline can be accessed through http://www.suicidepreventionlifeline.org/ and 1-800-273-8255. The people who answer the Hotline calls have tools and resources to help steer people away from suicide, and I hope that people use the Hotline as a resource. However, I’m bothered by my own suggestion that suicidal people “reach out.” I’m bothered by the suggestion because Marc DID reach out. He reached out to to many of us in the floxie community, including me. He asked questions and he sought advice, and he was given guidance to the best of our ability. But nothing helped, and his health continued to decline until he couldn’t take the pain any longer. Now he’s gone. I wish I had done more to help Marc. I wish I had known the right thing to say to him, or the right advice to give him that could have possibly shifted his path. I wish he was still here.

I know that there are others in the floxed community who feel guilt over not “doing more” to help Marc. I’m sure that you all did what you could. I did. But I wish I had done more, and I feel bad about not doing…. I don’t know…. more. But as a friend pointed out, why are we feeling guilt while the people who gave Marc the drugs that killed him feel no guilt or remorse about their role? The pharmaceutical company creators of Levaquin, the FDA (or the equivalent on Trinidad and Tobago), the doctors, etc. played an active role in poisoning Marc, but most of them have no idea, and they feel no guilt, while we do, and Marc is gone.

I hope that Marc’s family and friends know that the thoughts and prayers of many people throughout the world who “knew” Marc through the fluoroquinolone poisoned community are with him and them. He was clearly loved, and he is missed.

Levaquin, benzodiazepines, and Lyme disease killed Marc. He was tortured by the illnesses brought on by these pharmaceuticals for years, and I can’t say that I don’t understand how they could lead to his suicide. But, with all the love and respect in the world to Marc and his loved ones, can I please encourage all my floxed friends reading this to not go down the same path? Death is permanent. With death there is no hope or chance of healing. For every day that you are alive, there is a chance that healing will occur. There is the chance that discoveries will be made that will lead to cures. There is a chance that your body will cross a threshold toward healing. There is a chance of joy. There is a chance of love. There is life. There is hope.

I hope for strength for each of you. I hope that you get through fluoroquinolone toxicity. I hope that your body, mind, and spirit heal. I hope that you maintain hope, and that tomorrow (or the next day, or the day after that) brings the healing that you are hoping for.

I hope that Marc’s loved ones know that he touched the lives of many people throughout the world. He is missed, and our community is in mourning.

*****

Marc’s friend Nicholas asked me to share this message. It includes Marc’s last message.

Marco and I were friends since we met in 1999, best friends since 2002. We had a business together and we helped each other through some tough times and eventually, unwillingly, we were forced to dissolve the business for economic reasons and a shift in the landscape of home studios. It wasn’t easy. We had our differences of opinion and that coupled with other developments in my own life caused us to grow distant for a while though we frequently spoke via phone and message. We overcame our differences, our defunct business, and leaned on each other again and became brothers.

Over the last 3.5 years of him suffering we visited when we could, but spoke at least 3 or 4 times a week minimum for 30 mins to 3 hrs depending on how he was feeling. During the last 2 months, we spoke every day. I am recovering from my own issues, and I always hoped that he was doing the same, but it never came to pass.

Most people couldn’t endure watching him suffer. It was my honour to do so and help him through it, but to all who feel a ‘how’ just know, he understood. He often lamented that all those that surrounded him before had disappeared, but he knew how hard it was to watch someone suffer. He held no grudges.

Above all he wanted me to pass on this message so that people could know what he went through, what this drug, this dangerous ‘last resort only’ drug that is still treated like it was Panadol, did to him.

He was suffering from brain fog, which will be evident in his writing. I think it brings the message home with greater strength…

Marc’s words:

I wanted to write to you to thank you for all that you have done. Not once did I think that you didn’t do everything possible for my well being

The more I understand of my situation the more I realize I’m stuck in a very complicated viscous cycle. Iv just had a lot of trauma in my life that Iv struggled to let go of and it’s not because I have not tried but because it’s trsuma I have to relive everyday from young I was in pain and it was a physical and emotional struggle to do simple daily tasks even though I didn’t show it I certainly felt and I kept strong and pushed through. This built up trauma eventually weakens ones immune system and emotional health which I why I struggled so much with depresseion even though I didn’t show it as much

My accident breaking my hand was another trauma that started the ball rolling and then having surgery introduced anesthesia that also did not help the situation. Then came the final blow the levaquin which obviously damaged me in very serious ways I’ll never know for sure but I know was never the same after taking that drug.

I cannot begin to describe pain Iv felt everyday with having to live with CP. it was agony that existed both emotionally and physically. Then getting floxed and experiencing absolute nightmare symptoms daily And then to have so much taken away and have having fought to heal only to get worse and relapse due to who knows what. Fq toxicity is no joke and it has been just too much for me to deal with I have no life. This is not living.

Everyday since since I took that drug levaquin iv felt unattached, like my Head was filled with cotton and I couldn’t focus. every bit of sleep I got which was minimal I woke up to me extremities feeling like they were being crushed and burning. The main symptoms that were horrific with adrenal surges and BP spikesc of 210/110. Then it would drop to low 90/50. I have internal vibration that felt like if I was hooked up to a low voltage shocking station. I have severed moods swings with crying fits for no reason, my body felt heavy like someone filled me with lead. I feel completely exhausted but couldn’t sleep because i felt this pressure in my back my head that squeezed my head almost like if I had a parasite octoputus like thing in my head. Everyday I have severe abdominal pains that would feel like someone stabbing me with a knife. My mid and lower back would ache feel tense. I had several parts of my body feel numb and go completely week on a daily basic. My teeth would ache everyday. My jaw would be tense. My ears suffered horrible as they would be extremely sensitive to sound and burn life fire inside. I have nerve pain all over my body . I have stabbing bone pains in shins and arms. My vision is double blurry and not what It was. My chest feels like someone sucker punched me in the soloplexus. I have skin burning all over which feel so bad sometimes even taking a shower hurts. I feel like I’m out of my body with extreme brain brain fog fatigue and pressure all over my body and when I push to do anything I feel pressure all over my body with fatigues like some sucking energy out of me get worse. fingernails hurt and have arthritis like symptoms that make it hard to type play guitar etc. I have severe digestive issues with bloating constipation food intolerances. I can’t tolerate the sun or groups of people which makes going out or liming with friends almost impossible. My ears click with damaged euststion tubes so I hear things louder and sounds like resting a glass down on a table or a speaker phone would hurt my ears and I would hear audible distortion in my ears if I tried listening to music even at very low levels. All of these symptoms and more iv have endured from the day I took those pills. It’s now over 3 years and I still experience all of them in groups randomly everyday. Lack of sleep and depression have been a huge challenge as iv been not able to work feel joy do daily activities etc. fq toxicity is no joke and it ruins lives. Iv had countless doctors tell me it’s in my head it’s anxiety disorder. Bullshit. Cause after 2.5 years of hell I went on to antianxiety medication which barely helped. Except I feel more sedated but still can’t sleep. Fq toxicity can include damage of receptors in the brain that are responsible for managing our neurotransmitters. It can cause dna damage. Vegus nerve damage. Totally destroy your microbiome. Damage to mitochondria which is your main cells Responsable for energy production. It can damage immune function and send you body into extreme fight or flight which it did for me. Allowing infections viruses etc to wreck havoc as they have the oppertunity. After extensive testing in my journey to try and heal. I’m positive for Lyme , babesia , Scarlett fever, ebstein bar, cmv, herpes hsv 1 7 and 8, hpv. Rubella and a collection of parasites. What I did find out was I didn’t get my cerebral palsy from lack of oxygen at birth which usually leads to full body defects and speech problems. I had a different cp which is common with cmv virus infection in the nervous system. This would explain all my life I struggled with being unable to relax and have an easy time with relationships because my nervous system was compromised. It was difficult for me to be social. Well thing is the levaquin I took activated that virus and made it much worse along with everything I mentioned above so my cp got worse I now I’m forced to walk in crutches. Fq toxicity damages cyp450 liver engine pathways which responsable for metabolizing herbs drugs etc. no longer can I take pain killers thc or several other things that could have helped ease my suffering. This has affected me greatly as it’s affected my detox pathways and left me unable to detox like a normal person. Which creates a very toxic environment in your body which leads to more symptoms due to leaky gut and poor methylation.
These are things doctors are commonly unaware of and is why Iv had no real help because there really is no solution to what iv been going through. After 3 years and I’m actually worse off now after everything I’ve tried I really don’t know what else to do. All I know is life is absolute torture everyday and a struggle and I never knew someone could feel so bad. Only one who has experienced this could ever possibly get it.

I want everyone to know that there is so much more to what’s was going on with me that I would take a lifetime to explain. But the pain and torture that I go through nigh and day over and over again is just too much for one to endure. So please if your reading this don’t be angry or mad or sad or hurt because you think Iv done a bad thing. Know that I’m free of the worse pain and torture that I could ever imagine and please feel a sense of ease knowing that I no longer suffer. I know I’m my heart that my soul is in a beautiful place. And that it was just stuck in a sick body.

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.

 

******

EMA Recommends Restriction of Fluoroquinolones in Europe

The EMA (European Medicines Agency) just released a statement regarding fluoroquinolone use. It can be found through THIS LINK. The press release states:

Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use

Press release 05/10/2018

New restrictions follow review of disabling and potentially long-lasting side effects

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines. 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.

Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons and bones and the nervous system.

Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics.

The PRAC recommended that the remaining fluoroquinolone antibiotics should:

  • not be used
    • to treat infections that might get better without treatment or are not severe (such as throat infections);
    • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
    • to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic;
    • to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used;
  • be used with caution especially for the elderly, patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.

The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).

Prescribing information of individual fluoroquinolone antibiotics will be updated to reflect the restricted use.

The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use(CHMP), which will adopt the Agency’s final opinion.

This outcome from the PRAC of the EMA is due to the advocacy work of many European victims of fluoroquinolones, and especially the brave people who testified before the EMA on June 13, 2018. Here is a video that shows the hearing, and all the moving testimonials:

There is so much more work that needs to be done for those who have been floxed. We need remedies for fluoroquinolone toxicity, and more needs to be done to prevent people from being victimized by these drugs.

Still, the acknowledgement from the EMA, and the recommendations that they have given, are greatly appreciated, and I hope that they will prevent many unnecessary fluoroquinolone prescriptions.

 

 

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!

*****

New Study Finds that Ciprofloxacin Depletes Mitochondrial DNA

An excellent article about the effects of ciprofloxacin (a fluoroquinolone antibiotic) on mitochondrial DNA was recently published in the journal, Nucleic Acids Research. The article, Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2, by Anu Hangas, Koit Aasumets, Nina J Kekäläinen, Mika Paloheinä, Jaakko L Pohjoismäki, Joachim M Gerhold, and Steffi Goffart, gives a great amount of insight into the damage that ciprofloxacin does to mitochondria, and I recommend that you read it (linked through the article title). I’m going to go over the article in this post, and point out some of the more interesting findings.

First, a bit of background information to help readers to understand the article.

Mitochondria are the energy centers of our cells. There are over ten million billion mitochondria in the human body (Lane p. 1). Each cell (with a few exceptions) contains an average of 300-400 mitochondria that are responsible for generating cellular energy through a process called ATP (Adenosine Triphosphate). Mitochondria regulate energy production, aging, epigenetic signaling between and within cells and many other important functions. Proper functioning of mitochondria is vital, and when mitochondria are not operating properly, a wide range of disease states can ensue (2).

Mitochondria have their own DNA (mtDNA) that is separate from (though it interacts with) nuclear DNA. The structure of mtDNA is similar to that of bacterial DNA, and it is widely thought that mitochondria descended from ancient bacteria. The similarities between bacteria and mitochondria should make everyone take pause to think about how antibiotics of all kinds are affecting mitochondrial health. This post, and the article that it is based on, only focuses on the effects of ciprofloxacin, a fluoroquinolone antibiotic, on mitochondrial health, but if you want to read about the effects of other antibiotics on mitochondria, the article “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells” is a great place to start.

There are enzymes in our cells called topoisomerases. According to the wikipedia article for topoisomerase:

Topoisomerases are enzymes that participate in the overwinding or underwinding of DNA. The winding problem of DNA arises due to the intertwined nature of its double-helical structure. During DNA replication and transcription, DNA becomes overwound ahead of a replication fork. If left unabated, this torsion would eventually stop the ability of DNA or RNA polymerases involved in these processes to continue down the DNA strand.

In order to prevent and correct these types of topological problems caused by the double helix, topoisomerases bind to DNA and cut the phosphate backbone of either one or both the DNA strands. This intermediate break allows the DNA to be untangled or unwound, and, at the end of these processes, the DNA backbone is resealed again. Since the overall chemical composition and connectivity of the DNA do not change, the DNA substrate and product are chemical isomers, differing only in their global topology, resulting in the name for these enzymes. Topoisomerases are isomerase enzymes that act on the topology of DNA.[1]

Bacterial topoisomerases and human topoisomerases proceed via similar mechanisms for managing DNA supercoils.

The mechanism of action for all fuoroquinolones is that they are topoisomerase interruptors. The FDA warning label for ciprofloxacin states that the mechanism of action for 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.”

Here is a video that describes how fluoroquinolones work, and how they interrupt topoisomerase and thus interrupt the process of bacterial (and mitochondrial, as we shall discuss below) DNA replication.

I have argued, and I believe, that EVERY drug that is a topoisomerase interruptor, should be thought of as a chemotherapy drug. All other topoisomerase interrupting drugs ARE chemo drugs. But fluoroquinolones are thought of as antibiotics, and handed out as if they are inconsequential. They are extremely consequential though, and they are hurting too many people. More information on fluoroquinolones being chemo drugs can be found in the post, “Cipro, Levaquin and Avelox are Chemo Drugs.”

Now to highlight some of the important parts of Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2.

The abstract of the article, Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2, notes 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.”

When you look into the multiple roles of mitochondria–from controlling cellular energy production to aging, and the links between mitochondrial damage and various multi-symptom chronic illnesses (from ME/CFS to autism to autoimmune diseases), yes, most definitely, the damaging effects of fluoroquinolones on mitochondria can certainly explain many, if not all, of the side effects associated with fluoroquinolone antibiotics.

The study found that, “In agreement with the in vitro assay, also HeLa cells treated with ciprofloxacin or doxorubicin rapidly accumulated supercoiled mtDNA (Figure 3A).”

This accumulation of supercoiled mtDNA led to a “change in topology” of the mitochondria, and a depletion of the mitochondrial DNA. Per the article:

“The change in topology caused by the inhibition of mitochondrial Top2 was connected with an impairment of mtDNA replication. 7S DNA, the 650bp ssDNA strand incorporated at the D-loop region of mtDNA, was rapidly depleted upon ciprofloxacin, ethidium bromide and doxorubicin treatment.”

Ciprofloxacin treatment not only depleted mtDNA, it also inhibited mtDNA synthesis:

“ciprofloxacin treatment reduced mtDNA copy number by 18% within 3 days (Figure 3C). As at the same time the growth rate of ciprofloxacin-treated cells was strongly reduced doubling time 170.2 h versus 22.7 h in untreated controls (Supplementary Figure S4), the observed depletion reflects a nearly complete inhibition of mtDNA synthesis.”

Ciprofloxacin treatment, and the resulting supercoiled mtDNA, also stalled mtDNA replication.

“Ciprofloxacin caused a strong reduction in these intermediates already after 2 h treatment (Figure 3E). After 20 h, this effect was clearly enhanced, with the strand-asynchronous intermediates being replaced by strand-coupled replication intermediates, a hallmark of mtDNA replication stalling (25,31–33).”

It was also found that ciprofloxacin inhibited the increase of mtDNA that typically comes with building muscle. It was found that:

“The impairment of mtDNA maintenance by ciprofloxacin not only disturbed cellular proliferation and the physiological increase of mtDNA copy number during muscle maturation, it also effectively impaired the fusion of confluent myoblasts to multinuclear myotubes (Figure 4E) and cell differentiation as indicated by the reduced expression of the heavy chain of Myosin II, a marker of differentiated skeletal muscle (Figure 4F).”

In the paragraph that the above quote was taken from, it was stated that “This increase (of mtDNA when muscle matures) was completely abolished by ciprofloxacin.” I’ve said it multiple times before, but, again, fluoroquinolones should NEVER be given to athletes (or anyone who values their ability to move, or have their heart beat).

In the article’s discussion section, this summary of the demonstrated damage done by ciprofloxacin was given:

“Ciprofloxacin caused a dramatic effect on mtDNA topology, blocking replication initiation, reducing copy number and inhibiting mitochondrial transcription (Figures 2B3AE and 4A). Ciprofloxacin, the third most commonly used antibacterial antibiotic, stops the cleavage/re-ligation reaction of type II topoisomerases midway, generating double-strand breaks, persistent protein–DNA adducts and reduces also the overall enzyme activity (30). Its toxicity to mitochondria has been reported in various studies, suggesting a broad range of mechanisms including topoisomerase inhibition, oxidative stress, altered calcium handling and photosensitization (38–40). In our study, we observed ciprofloxacin to clearly reduce Top2 topoisomerase activity both in vitro and in vivo, but did not find any indication of increased mtDNA double-strand breaks (Figure 3AC). However, ciprofloxacin did impair the overall mtDNA integrity in post-mitotic cells (Figure 4D). As our detection method (long-range PCR) does not distinguish between strand-breaks, abasic sites or base alterations inhibiting Taq polymerase, the observed effect might be caused by oxidative damage, which fluoroquinolones have been reported to induce in a variety of cell types (41,42).”

And the study’s authors also surmise that many of the severe adverse effects of fluoroquinolones are due to the depletion of mtDNA caused by the drugs:

“The severe side effects of ciprofloxacin and other fluoroquinolones include tendinopathies such as tendon rupture, joint inflammation, muscle weakness, central and peripheral neuropathies, epilepsy and psychological symptoms such as depression. These symptoms have been proposed to be connected to enhanced oxidative stress (42,54,55), but the molecular mechanism remained unclear. The reduction of mtDNA copy number and mitochondrial transcription caused by the altered topology of mtDNA might result in severe dysregulation of the electron transport chain complexes, as known to occur under ciprofloxacin treatment (56), lead to respiratory chain dysfunction and cause the observed enhanced oxidative stress.

Ciprofloxacin has also been reported to interfere with physiologically significant cell differentiation processes, such as spermatogenesis (57), brain development (41), bone mineralization (58), as well as to induce renal toxicity and heart arrhythmia (59). While the molecular mechanisms of these adverse effects are yet unclear, mitochondria play a central role in all of these physiological processes, making mitochondrial impairment a likely culprit for the disturbed cellular physiology.”

Throughout the article, the effects of ciprofloxacin are compared to the effects of another topoisomerase interrupting drug, doxorubicin. Per its wikipedia post, Doxorubicin “is a chemotherapy medication used to treat cancer.[3] This includes breast cancer, bladder cancer, Kaposi’s sarcoma, lymphoma, and acute lymphocytic leukemia.” The authors of Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2 noted that, “Interestingly, doxorubicin had a similar, but milder inhibitory effect on mtDNA replication than ciprofloxacin.” Why, yes, it is interesting that a drug that is marketed and dispensed as an antibiotic is more damaging than a similar drug that is marketed and dispensed as a chemotherapy drug. It’s very interesting indeed. It is also interesting that another topoisomerase interrupting chemotherapeutic drug, topotecan, was found to increase the expression of genes related to autism (“Topoisomerases facilitate transcription of long genes linked to autism“).

The Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2, authors conclude their article with two points. First, that very little is known about the consequences of mtDNA supercoiling. “Although central in bacterial genome maintenance, the whole phenomena of DNA supercoiling and its functional implications are virtually unstudied in mitochondria and calls for future research.” Yes, future research is needed, and better late than never. But nalidixic acid, the backbone of all fluoroquinolone antibiotics, was first used clinically in 1967. Shame on the medical and scientific communities for not studying the effects of fluoroquinolones on mtDNA earlier. We should have known more about the consequences of these drugs long before millions of prescriptions had been doled out, and millions of people affected.

Second, the authors of Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2 conclude by stating, “As fluoroquinolone antibiotics are widely used and effective drugs against a number of important bacterial pathogens, their dosage, systemic enrichment and side-effects should be reviewed in the mitochondrial context, and their clinical use should be considered with great care.” Yes, indeed, the effects of fluoroquinolones on mitochondria should be given long, hard, thoughtful consideration by every doctor, pharmacist, scientist, and every relevant person in the FDA and other regulatory agencies.

Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2 is an eye-opening article with groundbreaking research. Yes, more research needs to be done. But the research that has been done, that is described in the article, is greatly appreciated. Thank you to all the authors – Anu Hangas, Koit Aasumets, Nina J Kekäläinen, Mika Paloheinä, Jaakko L Pohjoismäki, Joachim M Gerhold, and Steffi Goffart.

 

Fluoroquinolone Prescription Guidelines for Children

The ONLY FDA approved uses for fluoroquinolones in children are:

  1. Anthrax
  2. Plague
  3. Complicated urinary tract infections

That’s it.

All other uses of fluoroquinolones in children are off-label. All pediatric fluoroquinolone prescriptions for treatment of sinus infections, uncomplicated urinary tract infections, respiratory infections, diarrhea, ear infections, etc. are off-label. The FDA has not done a cost-benefit analysis, or a safety analysis, for any use of fluroquinolones in children, other than for treatment of anthrax, plague, and complicated urinary tract infections.

The reason that fluoroquinolones are not approved for most pediatric uses is because, “Fluoroquinolone-induced joint/cartilage toxicity has been observed in juvenile animal studies and is species- and dose-specific with canines exhibiting the highest rate of arthralgias. These early observations led to the contraindication of fluoroquinolones in the pediatric population” (source). Additionally, serious musculoskeletal and nervous system adverse reactions occur at higher rates in children treated with fluoroquinolones than children treated with other antibiotics (source). To put it into simple terms, fluoroquinolones have been shown to cause lameness, stunted growth, joint pain, and other permanent musculoskeletal problems in experiments on juvenile mammals (beagle puppies).

Despite the evidence that fluoroquinolones can cause irreparable musculoskeletal damage to juvenile mammals, there are some people who argue that fluoroquinolone use should be expanded in the pediatric population. Additionally, fluoroquinolones ARE prescribed to children, despite the fact that they cause lameness and arthralgia in animals, and the fact that there are no FDA approved indications for fluoroquinolones other than anthrax, plague, and complicated urinary tract infections.

The Hippocratic Oath and the precautionary principle should be the guiding thought processes when prescribing drugs to children. Drugs that have been shown to cause lameness in juvenile animals, and that have multiple black-box warnings on them, should not be given to children. The current black-box warning for fluoroquinolones states that they can cause “disabling and potentially irreversible serious adverse reactions.” No child should be subjected to even the risk of permanent musculoskeletal problems that could result in disability.

Yet… children are being prescribed fluoroquinolones every day, and they are being put at risk. Because of hubris and the general acceptance of off-label prescribing in medicine, many doctors are subjecting children to the risk of fluoroquinolone toxicity–a constellation of symptoms that includes not only serious musculoskeletal problems, but also autonomic nervous system dysfunction, neuropathy, psychiatric disturbances, blood-sugar irregularities, and more.

It’s not okay. Even the FDA, as ineffective as they are, recognizes that it is not appropriate to subject children to the risk of serious and permanent adverse drug reactions unless they are faced with life-threatening infections like anthrax and plague.

But too many doctors either don’t realize that fluoroquinolone adverse-reactions are severe, or they think that they can gauge the appropriateness of the risk of their prescribing behavior better than the FDA, and they prescribe fluoroquinolones off-label. This is absurd, foolish, and dangerous. Off-label prescribing is essentially experimental. It is not “evidence based medicine,” it is “throw it at the wall and see if it sticks” medicine. And everyone whose child was given a fluoroquinolone for treatment of an infection that wasn’t anthrax, the plague, or a complicated urinary tract infection was, in a sense, experimented on. The approved uses for Levaquin/levofloxacin, Cipro/ciprofloxacin, Avelox/moxifloxacin, and the other fluoroquinolone antibiotics in children are limited, but few doctors are paying attention to what the approved indications for fluoroquinolones are, and I doubt that most physicians even know that fluoroquinolones are not approved for use in children for, say, skin infections, or travelers’ diarrhea, or sinus infections, or swimmer’s ear, etc.

It is awful when anyone is prescribed a dangerous drug in a reckless or uncalled-for way, but it’s particularly horrible when it happens to children. Tragically, children are being hurt by negligent, off-label fluoroquinolone prescriptions. It’s not okay. Yet the FDA, and other world-wide regulators of medicines, are not doing anything to stop this practice. If the FDA is going to pretend to regulate the use of pharmaceutical drugs, they should start with curbing the practice of off-label prescribing – especially for pediatric patients. After all, what good are prescribing guidelines if no one pays attention to them?

Fluoroquinolones are too dangerous for anyone who is not facing a life-threatening infection to use. They are certainly too dangerous for use in children. The FDA knows this, yet they are unwilling to do anything to enforce their own guidelines around pediatric fluoroquinolone prescriptions. Tragically, children are being hurt because of doctors who prescribe fluoroquinolones off-label – and the FDA is unwilling to do anything to stop it.

 

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!

 

 

The Bleeding Edge and Parallels with Fluoroquinolone Toxicity

Have you seen the documentary The Bleeding Edge? It’s a wonderful film about the hazards of medical devices that I highly recommend. It’s currently (August 2018) available on Netflix. If you haven’t seen it, please do. It is an eye-opening, thought-provoking, insightful, frightening film.

The Bleeding Edge features stories from people who have suffered adverse reactions to various medical devises and procedures. Victims of Essure, mesh implants, metal hip replacements, and robotic surgical procedures report the harm done to them by these devices and procedures in the film.

The Bleeding Edge is a stark and scary reminder that, unfortunately, too often doctors are not abiding by the Hippocratic Oath. “First, do no harm” has gone by the wayside as these products and procedures maim their victims. Compounding the tragedy of the harm caused by these devices or procedures is the fact that, in many cases, there are safer devices or procedures available that would have had the intended results that the patients (and presumably their physicians) sought. Tying a woman’s tubes is a safer method of permanent sterilization than Essure; ceramic hip replacements are safer than metal ones; physical therapy can strengthen the pelvic floor and relieve symptoms of incontinence as well as mesh can; and, a surgeon’s hand may be a safer tool than a robotic arm. However, these safer procedures were not performed on the victims featured, or on thousands of other people, because the entire medical system ignored their Hippocratic Oath. Doctors (or administrators or insurance companies) were swayed to use these newer less-safe methods by marketing, efficiency, money, or ignorance–and patients were hurt in the process. It’s not okay, and steps back toward the basis of medicine in the Hippocratic Oath are, sadly, necessary.

There are several parallels between the experiences of people hurt by fluoroquinolone antibiotics (i.e. “floxies”) and the people featured in The Bleeding Edge. The adverse reactions to Essure are particularly similar to adverse reactions to fluoroquinolones. Adverse reactions to Essure look, and seem to feel, an awful lot like autoimmune diseases. Likewise, fluoroquinolone toxicity looks and feels a lot like an autoimmune disease. Essure adverse reactions are often severe and they affect multiple bodily functions. The women who had adverse reactions to Essure often suffered from permanent disability, even after the metal springs were removed from their body. Likewise, even long after fluoroquinolones “should” be out of a person’s body, the effects remain. Unfortunately, both Essure and fluoroquinolone adverse reactions can be permanent.

Like those featured in The Bleeding Edge who suffered from the toxic effects of metal-on-metal hip implants, fluoroquinolone victims often experience psychiatric adverse reactions. Fluoroquinolones can induce many serious mental health symptoms, and the FDA recently added “disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium” as highlighted adverse reactions to fluoroquinolones. Fluoroquinolones can also induce psychosis. The patient featured in The Bleeding Edge that suffered from psychosis, tremors, and other serious mental adverse effects from a metal hip replacement, is an Orthopedic Surgeon himself, and he “said he would never have believed neurological problems could come from orthopedic devices, if it wasn’t for that experience, and now tests the cobalt levels of his patients if they complain of having Parkinson’s or dementia-like symptoms.” (source). The victims of metal hip replacements are often told that their symptoms are simply a result of getting older. Fluoroquinolones are given to people of all ages, but those who are over 30 are often told that their symptoms are from “getting old” not from the drugs.

None of the adverse reactions featured in The Bleeding Edge are what one would intuitively expect an adverse reaction to look like. Who would think that a type of hip replacement could lead to psychosis? Who would think that a sterilization procedure could lead to a permanent autoimmune/neuroimmune disease? Similarly, who would think that a commonly prescribed class of antibiotics could cause multi-symptom, chronic, illness that has a lot in-common with these illnesses brought on by medical device adverse reactions? It’s absurd and unbelievable. It’s true though. Adverse reactions don’t look like they are “supposed” to look. They aren’t intuitive and they aren’t easy to identify.

Hopefully The Bleeding Edge will reform how patients and doctors alike view medical device safety. I hope that it also reforms how people think about adverse reactions generally, and that recognition of the connections between adverse drug and device reactions and multi-symptom, chronic, “mysterious” diseases starts to enter mainstream consciousness.

Watch The Bleeding Edge. It is a great film that has a message that needs to be heard.

Sorry, I don’t know how to squeeze this in gracefully, but several of the victims featured in the film had their intestines fall out of their bodies post-hysterectomy via robotic surgery. Is that not one of the most horrifying things imaginable–to have your intestines fall out of your body? Aaaaaaagh!!! Floxies can at least be thankful that our organs generally stay inside our bodies.

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!

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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.

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Change Will Come

Ruth wrote this guest post. You can read Ruth’s story of fluoroquinolone toxicity in “Ruth’s Story – Cipro Toxicity.” You can also listen to Ruth’s story through her episode of The Floxie Hope Podcast. THANK YOU, for sharing your insight and wisdom, Ruth! 

There was a long period of time after I got floxed that I despaired of anything ever changing in the medical field. I didn’t think doctors would ever change their prescribing habits regarding fluoroquinolones and people would continue to be harmed as I was, until the end of time, basically. But I recently had an epiphany that brought the realization that not only will the overuse of fluoroquinolones stop, it is inevitable that it does stop.

It is true that America’s FDA is doing a poor job of keeping the public safe from bad drugs and faulty medical devices. But I believe that even if the FDA does not become the watchdog it should be, the needed changes regarding fluoroquinolones will come. Probably not as soon as any of us would like, but they will come.

Every summer I work as a pyro technician for a display fireworks company. I have to undergo training for this. I am kept abreast of the requirements of the ATF, our own industry, and our company. Our own company is stricter than the legal requirements as regards safe distances for spectators. Our own industry has made recommendations to improve safety which are also stricter than what the ATF requires. Sometimes these requirements can seem burdensome or inconvenient.

Why would a fireworks company and professional organizations made up of pyro technicians create their own stricter regulations, when it would be easier to just stick with whatever is legally required? Because sane and rational people want to keep the public safe. Yes, we want to put on a good show, make some money and no one in this world actually wants to have to work harder– but at the end of the day no sane and rational person would want to be responsible for injuring another human being.

I believe the doctors themselves and others working in the medical industry will in the end solve this problem, whether or not the FDA ever wakes up and provides some regulations for use of fluoroquinolones that have some teeth. I believe even the drug companies will reluctantly come around due to social pressure or fear of litigation. I believe this because if it happened in one industry it can happen in another.

New and stricter regulations regarding the transport, handling and use of display fireworks have been met with resistance. I don’t want to paint a picture that says every time a new rule is added everybody is happy about it and immediately gets on board with it. But I have heard the arguments for continuing the old ways and I know why they aren’t holding up, why changes are happening despite opposition. The arguments against changing how fireworks shows are done are the same ones that are used against changing how fluoroquinolones are prescribed. They are all flimsy arguments. Here’s my list:

  1. We’ve always done it this way.
  2. It’s easier to do it this way.
  3. It’s cheaper to do it this way.
  4. I don’t believe this really makes a difference for safety, because I personally have never seen anyone get hurt doing it this way.

Let’s take these one at a time:

We’ve always done it this way” simply does not hold up when the science says what you have been doing is not safe. In both industries those advocating for safety have science on their side. Also, it is mainly the older pyros and older doctors using this argument. As they retire, and young people coming in are trained in a different way, this argument will simply disappear. I have had young pyro technicians come to me and say that an older person on the crew showed them how to do something that was inconsistent with training they received. I confirm that they have to do it the way they were trained and I never get an argument from them.

The more experienced person may continue to argue on the basis of, “I have always done it this way,” but the younger person will distrust anything that goes against the training he or she received. I have heard of some medical schools today teaching about fluoroquinolone toxicity syndrome and cautioning students to avoid using FQ’s unless really necessary. These are second and third hand accounts, but if they are true this is a huge win for us.

Some of the older pyro technicians, sad to say, take themselves out of the picture by choosing to continue doing things that we know today are not safe. Doctors who simply refuse to believe in the dangers of fluoroquinolones and take those drugs themselves also may learn the hard way. I’m not saying people getting hurt should be celebrated, absolutely not, but every time the lesson is learned the hard way it is still learned.

It’s easier to do it this way,” does not fly either in the face of how much people can be harmed. In one case we are talking about explosives that, if they don’t go off in the sky where they are supposed to become actual bombs on the ground, and in the other case we are talking about medications whose side effects have been described many times as being like a bomb going off in the person’s body. The amount of voices speaking out on the horrors of fluoroquinolone toxicity helps our case because after people have read our stories they don’t want to risk FQ toxicity no matter how much the doctor may claim Cipro has a great record of safety and efficacy.

The informed patient is going to request that the doctor culture the infection and prescribe accordingly, rather than just prescribe the broad spectrum antibiotic because it is easier. Patients are refusing to take the atomic bomb of antibiotics when they might not need an antibiotic at all. Being handed Cipro and sent on your way without even knowing for sure you have an infection is not going to continue to be accepted medical care. Those of us who speak out to our friends and post about this here at floxiehope and on social media are part of that change, and we can feel good about that. The dangers are becoming known.

Customers can and do drive changes that improve safety. For a recent fireworks show we were informed that the sponsor had requested we follow recommendations by our own industry for distance between loaded mortars. They were actually asking that we follow California’s standards, even though the show was shot in Wisconsin. What reason could we give for not doing what the customer asked? It’s easier to be able to load all the mortars right next to each other in the old style racks than to skip tubes or use the newer ones that have the required spacing? That would have been our only reason to refuse that request: It’s easier to do it the old way.

But the sponsor was making the request because he wanted as safe a show as possible. When patients make requests of their doctors because they want to be as safe as possible the doctor cannot really make any argument that is going to hold up as to why he should not honor those requests. Today we are seeing customers of display fireworks companies taking the time to inform themselves about our industry and what we do! How much more so are patients today taking the time to become informed? In both cases it is happening because the Internet makes information about any subject easily available. When we speak out about our reactions to fluoroquinolones we are helping provide valuable information for others.

It’s cheaper to do it this way,” may seem to be a logical reason to resist changes. After all, companies need to watch their bottom line. But when it comes to a question of money or public safety, the need for public safety will eventually win. There may be a period of time during which companies can make some money while risking the health and safety of other human beings, but eventually that time will end.

People have a desire for self preservation. Whether it is pyro technicians experiencing danger from low breaks, round trippers and finale racks blowing up or patients experiencing or reading about bad ADR’s to a drug, people are going to run the other way when their life or health could be put in danger. Fireworks companies that buy cheap but unreliable product lose workers and have difficulty selling more shows without crews to put them up. Hospitals that use fluoroquinolones for every little thing lose informed patients. If I needed surgery I know where I would go for it, because I know of hospitals (a couple) that do not use fluoroquinolones. If I had to pay out of my own pocket I would do it, because my health and safety is that important to me.

I know of display fireworks companies that are now out of business after consistently focusing on the bottom line instead of safety. I believe the same will hold true for medical facilities, doctors and even drug companies that continue to put money ahead of human health and safety. The display fireworks company I now work for tests all their product and they spend extra money to get product that is going to perform as it is supposed to. They are rewarded for this not only with greater customer satisfaction for some really beautiful shows, but they attract more workers. Pyro technicians would rather work where they feel safe and know they are not putting members of the public at unnecessary risk.

I think the same holds true in health care. I used to work for a medical staffing company in physical therapy. Some companies I temped for definitely cared only about the bottom line, with very high productivity standards. I was so rushed that I knew I was not really able to provide good care, and that put patients and myself at risk. I stopped taking jobs for those companies. Companies that had compassion for both their patients and employees attracted the best workers and could even pick and choose, selecting the cream of the crop of therapists, doctors and nurses. Patient satisfaction went up. While some of the companies that had pushed so hard for productivity were being bought out, the companies that I most preferred to work for were thriving. Decisions made with concern only for the bottom line always come back to bite the companies making them right in the butt.

I don’t believe this really makes a difference for safety, because I personally have never seen anyone get hurt doing it this way,” was the excuse my own doctor used for prescribing Cipro to me for a sinus infection. She had personally never seen anyone have a reaction to Cipro. Well, that is anecdotal evidence and it’s weak. The medical community cannot on one hand say that mountains of anecdotal evidence that fluoroquinolones are harming people is not strong enough evidence and then use anecdotal evidence themselves for their continued widespread use. The changes the FDA recommended for the use of fluoroquinolones in 2016 were made for a reason. A panel of experts heard the testimony of those harmed and looked at medical research regarding fluoroqouinolones and made an informed decision. Making a decision based only on your own experience and observations is not an informed decision.

I say that change will happen in the medical field because in the pyrotechnic industry change is happening. When a change is recommended in how something is done it is probably because somebody got killed doing it the old way. People who want to be safe believe those recommendations even if they personally never witnessed an accident. The same will happen with doctors. Even if they never personally had a patient get floxed, they will follow FDA prescribing guidelines for FQ’s because they do not want to harm other human beings.

One thing that does stand in the way of this change is cognitive dissonance created by the very fact that no sane and rational person wants to harm another human being. As the evidence comes out that fluoroquinolones are insanely dangerous and that the side effects are horrific, long lasting and sometimes permanent, doctors do not want to believe that they put anyone through that. The fact that reactions are delayed means they most certainly could have severely harmed a patient and never known about it because the connection to the antibiotic was never made. It is going to be very hard for doctors to come to terms with this, and I think it is behind a lot of their strident claims that Cipro is “safe and effective.” They need it to be, because if it were not, then there is a good chance they have harmed those they meant to help.

A floxed friend recently shared her experience with an ER doc who tried to give her Cipro for a UTI without even culturing to confirm an infection. She gave him an earful and the expression on his face said that she got through to him. He was horrified. He will either now disbelieve her because he must to avoid a truth he cannot face (that he may have harmed patients) or he will do some research, find the truth, change his prescribing habits and speak to his colleagues. I believe that in time even this cognitive dissonance will be overcome and doctors will do what is right, follow the recommendations of the FDA, and stop prescribing fluoroquinolones in situations that do not warrant their use.

The fluoroquinolone catastrophe has gone on far too long. It can be discouraging to reflect on how many have been needlessly harmed. However, as I have observed changes happening in the pyrotechnic industry that, although sometimes opposed, do happen and do increase public safety, I have to believe that the medical industry is not immune to those same types of changes. I think if it were easier to sue for harm done by pharmaceuticals, that would actually be a good thing, because sadly, there are some people out there who are neither sane nor rational, but consumed with greed. Only one thing gets their attention, and that is losing money. There has to be more accountability for drug companies and doctors who prescribe dangerous drugs needlessly. I do believe it will happen and in the meantime, as we inform people about the dangers of fluoroquinolones we are playing our part in bringing about these much needed changes to the medical industry.