Tag Archives: Peripheral neuropathy

Fluoroquinolone Antibiotics Associated with Carpal Tunnel Syndrome

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

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

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

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

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

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

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

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

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

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

 

 

Floxie Hope Podcast Episode 24 – PJ

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

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

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

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

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

 

 

 

 

Mitochondria, Neuropathy, HIV, and Fluoroquinolones

Mitochondria and Peripheral Neuropathy – Article out of Johns Hopkins

I highly recommend reading this article –

Feet First? Old Mitochondria Might Be Responsible For Neuropathy In The Extremities

It’s a fascinating article out of Johns Hopkins Medicine.

It goes over the connection between mitochondrial damage and peripheral neuropathy.

As an explanation as to how dysfunctional mitochondrial lead to peripheral neuropathy, the article notes that:

“He and his colleagues suspected that the reason (for peripheral neuropathy) might lie within mitochondria, the parts of cells that generate energy. While mitochondria for most cells in the body have a relatively quick turnover — replacing themselves every month or so — those in nerve cells often live much longer to accommodate the sometimes long journey from where a cell starts growing to where it ends. The nerve cells that supply the feet are about 3 to 4 feet long in a person of average height, Hoke explains. Consequently, the mitochondria in these nerve cells take about two to three years to travel from where the nerve originates near the spine to where it ends in the foot.”

Peripheral Neuropathy and HIV/AIDS

It is also noted in the Johns Hopkins article that peripheral neuropathy is “a condition that often accompanies other diseases including HIV/AIDS.”  I wonder, is peripheral neuropathy in HIV/AIDS patients caused by the disease, or the treatment for the disease?  In Mitochondria as a Target of Environmental Toxicants, it is noted that:

“Another example is the nucleoside reverse transcriptase inhibitors (NRTIs) that are used to combat human immunodeficiency virus (HIV) infection. NRTIs act by inhibiting the reverse transcriptase activity required for viral replication. They have been highly successful in treating adults and in preventing transmission of HIV from pregnant mothers to their children, but unfortunately many NRTIs also inhibit the mtDNA polymerase γ. This has resulted mtDNA depletion- and mutation-mediated mitochondrial toxicity, and even death, in patients and in animal models (Benhammou et al., 2007; Blanche et al., 1999; Chan, 2007; Claessens et al., 2003; Divi et al., 2010; Kohler and Lewis, 2007). Similar effects have been observed with nucleoside analogs intended for other viruses as well (McKenzie et al., 1995). Thus, chemicals that damage mtDNA or alter its copy number can have very serious health consequences.”

Pharmaceuticals and Mitochondrial Damage / Peripheral Neuropathy

I think that the article out of Johns Hopkins is great, and I greatly appreciate the research that has been done.  However, I suspect that the researchers missed an opportunity in not noting that drugs that deplete mitochondrial DNA are responsible for many cases of mitochondria related peripheral neuropathy.

The damage to mitochondria done by NRTIs is well documented.

Other drugs, including fluoroquinolone antibiotics – Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin – are also well-documented as being destructive to mitochondria AND causing peripheral neuropathy.

In the article, Calcium Signals Are Affected by Ciprofloxacin as a Consequence of Reduction of Mitochondrial DNA Content in Jurkat Cells, it is noted that ciprofloxacin, a fluoroquinolone depletes mitochondrial DNA content.  It is also noted in the article, Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells, that ciprofloxacin treated cells show a loss of mitochondrial DNA.

Though Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells was published in 1996, it was not until 2013 that the FDA added the risk of permanent peripheral neuropathy to the warning labels for fluoroquinolones.   The case study, Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration illustrates the severity of peripheral neuropathy brought on by (the mitochondrial damage done by) fluoroquinolones.

It is also noted in the FDA’s April 27, 2013 Pharmacovigilance Review, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” that the mechanism for action through which fluoroquinolones induce peripheral neuropathy is mitochondrial toxicity. The report says:

“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.”

Conclusion

I really do appreciate the research described in Feet First? Old Mitochondria Might Be Responsible For Neuropathy In The Extremities.  Experiments, analysis and scientific documentation are needed.  But synthesis of existing information is needed too.

Drugs that deplete mitochondrial DNA are leading to peripheral neuropathy.  Perhaps the Johns Hopkins study is the piece of the puzzle that is missing from widespread recognition of this.

We shall see.

FQ Toxicity Featured in The Healing Pain Summit

 

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I had the honor of being interviewed by Dr. Joe Tatta, DPT, CNS, for the Healing Pain Summit. In our interview, we discussed how fluoroquinolones can cause chronic pain and disability. Even before we spoke, Dr. Tatta was aware of fluoroquinolone toxicity and the pain and disability caused by fluoroquinolone antibiotics. He has treated several patients who have experienced the pain and trauma of fluoroquinolone toxicity. It was an honor to speak with a doctor as knowledgable, compassionate, and understanding as Dr. Tatta.

Please join me and Dr. Tatta, as well as an incredible panel of other guests (including Dr. Terry Wahls, Dr. Robyn Benson, Jessica Drummond, MSPT, CCN, Dr. Beth Darnall, Dr. Tyna Moore, DC, ND, Mira Dessey, Niki Gratrix, Dr. Jay Davidson, DC, Damian Dube, Dr. Reef Karim, Dr. Keesha Ewers, David Butler, PT, EdD, Marcelle Pick, OB/GYN NP, Karen Litzy, PT, DPT, Dr. Kim D’Eramo, Dr. Ann Shippy, MD, Dr. Mitchell Yass, By Debora Wayne, Dr. Ritamarie Loscalzo, MS, DC, CCN, DACBN, and Connie Zack – what a lineup!), for the Healing Pain Summit.

The Healing Pain Summit starts on Monday September 12th and goes through September 17th, 2016. You can register for the Summit for FREE through THIS LINK. After September 17th you can still access the interviews, but there is a charge for them.

I hope that The Healing Pain Summit helps those of you who are dealing with fluoroquinolone-induced pain!

I also hope that my participation in this wonderful event helps people to recognize that fluoroquinolones can cause chronic, and often debilitating, pain. I hope that my speaking out on the Healing Pain Summit helps people to “connect the dots.” There are a lot of people out there with fibromyalgia, chronic fatigue, joint pain, arthritis, rheumatoid arthritis, peripheral neuropathy, POTS, anxiety, and more, who have taken Cipro/ciprofloxacin, Levaquin/levofloxacin, or Avelox/moxifloxacin in the past, and those fluoroquinolones may have contributed to their painful conditions.

Please help me to spread the word about the pain caused by fluoroquinolones by sharing this post, with your doctors, friends, and loved ones. Thank you!!

Each guest on the Healing Pain Summit is offering a free gift to those who sign up. You can see the list of the free gifts HERE. The free gifts are incredibly useful and valuable, and I also hope that they help each of you!

A bit more about the Healing Pain Summit:

Through this expert event, Dr. Joe is completely rewriting the dialogue around pain, injury, healing and the growing epidemic of addiction to pain medications.

At no cost to you, Dr. Joe has gathered the top leaders in science and medicine to pull back the curtain and bring their top-notch, cutting-edge information on injury, illness, chronic pain, and pain management to you.  These are life-changing protocols and ideas that are just coming to light.

When you discover exactly how your body works and how to heal yourself naturally, you get your body working FOR you and not AGAINST you.

Thank you so much for joining me for the Healing Pain Summit! Also, a huge THANK YOU to Dr. Joe Tatta for including me and for the help in getting the word out about fluoroquinolone toxicity.

 

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K-PAX for Floxies

KPAX Immune

Just to note upfront, I have no affiliation with K-PAX. I have not been asked by them to write any of this. The following post is for your information only and I hope that it’s helpful!

In October, 2015 I received the following email:

I was recently introduced to K-PAX Pharmaceuticals who is conducting research on mitochondrial toxicity, thought to be a cause of the symptoms associated with Fluoroquinolone use.

Their main immune support formula was originally created to decrease the toxicity caused by antiviral medications in the HIV population. These medications caused similar symptoms, including peripheral neuropathy, as seen in Fluoroquinolone use. This Immune Formula was shown to achieve a 33% decrease in peripheral neuropathy for these patients. Their goal was to provide high levels of antioxidants in order to combat free radicals associated with the medication toxicity. Patients taking this formula also had a 26% increase in their CD4 count. This formula boosted their immunity by improving their mitochondrial health. This research was published in the Journal of AIDS (Kaiser, J. D., Campa, A. M., Ondercin, J. P., Leoung, G. S., Pless, R. F., & Baum, M. K. (2006). Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial. JAIDS Journal of Acquired Immune Deficiency Syndromes, 42(5), 523-528).

The reason I started looking in to K-PAX’s Immune Formula was after coming across the 2013 FDA Pharmacovigilance Review entitled, “Disabling Peripheral Neuropathy Associated with Systemic Fluorquinolone Exposure.” This paper draws the same connection between damaged mitochondria function from medication toxicity and peripheral neuropathy. In it, the FDA states, “A human prospective study was done to evaluate oxidative stress in patients taking different doses of ciprofloxacin, levofloxacin, and gatifloxacin for 5 days for complicated UTI. Superoxide dismutase (SOD), and endogenous antioxidant enzyme that removes free radicals, glutathione, another major antioxidant, plasma antioxidant status and lipid peroxides were evaluated in the 52 patients. Results showed that ciprofloxacin had a significant increase in lipid peroxide levels from the first to the fifth day, almost doubling. There was also a significant decrease from (73% to 32%) in SOD, as well as glutathione. The results were similar for levofloxacin, although to a lesser degree, but these results were not seen with gatifloxacin. This study showed how increase in lipid peroxides can quickly overwhelm what is left of the plasma antioxidants, leading to impairment of cell integrity and cell death.”

From what I understand, K-PAX Pharmaceuticals is currently focusing their research on chronic fatigue syndrome and fatigue related to other medical conditions. They are looking at mitochondrial dysfunction as the cause for these conditions as well. They just published a paper about their clinical trial using their Immune Support Formula for mitochondrial damage in patients with chronic fatigue syndrome. (Kaiser, J. D. (2015). A prospective, proof-of-concept investigation of KPAX002 in chronic fatigue syndrome. International journal of clinical and experimental medicine, 8(7), 11064).

I wanted to share this information with you and your readers as I have been doing a lot of research for my own condition and see more and more reference to mitochondrial damage as a culprit so I decided to give it a try. I have now been using the K-PAX Immune Formula for the past 6 months and have seen a significant decrease in my neuropathy and improvement in my energy level. My brain fog has lifted and I feel an improvement in my overall health. I like the fact that this product is actually helping to heal my mitochondria and reverse the cell damage caused by these toxic medications.

After corresponding with the author a bit, I sent an email to the folks at K-PAX asking if they had ever heard of it being used to help people through fluoroquinolone toxicity. The next day I received a phone call from the K-PAX Medical and Community Liaison, Deirdre. Deirdre wasn’t familiar with fluoroquinolone toxicity specifically, but she was familiar with mitochondrial toxicity, drug-induced mitochondrial toxicity, and many of the diseases that FQ toxicity resembles (like autoimmune diseases, fibromyalgia, ME/CFS, Gulf War Syndrome, etc.). Deirdre and I chatted extensively about fluoroquinolone toxicity and we decided that there was mutual interest in seeing how the K-PAX supplements worked for floxies. Deirdre/K-PAX offered to send 15 floxies a month’s supply of K-PAX Immune Support to see if it helped them.

I selected 15 floxies (first come, first serve – and I tried to get a decent age and gender mix) to receive the K-PAX Immune Support supplements and, about a week later, they started taking them.

Please note that this was in no way an official trial or experiment. I asked that all the floxie participants be willing to give me feedback about their experience, but that was the only obligation.

After everyone had time to complete the supplements, I sent out a survey to see how people liked the supplements and how they reacted.

You can view the survey results HERE.

To summarize*:

  • 37.5% of respondents had FQ toxicity symptom improvement while taking the supplements, 37.5% did not, and 25% of the respondents answered “other” to that question.
  • Fatigue relief and increased energy were two of the symptoms that some people experienced relief of.
  • 62.5% of respondents said that they would recommend K-PAX supplements to other floxies. Their reasons for recommending it to others included, “I have 20 years experience trying to recover, bio-available nutrients have been the only thing to combat the symptoms I have found,” and, “I have seen improvement in my fatigue,” and, ” if ANYTHING can help, it’s worth a try.”

If you would like to try the K-PAX supplements, they are available through the K-PAX store – http://www.kpaxpharm.com/. Additional information can be found on http://www.kpaxpharmaceuticals.com/.

I would also like to note that it was very generous of the K-PAX personnel to send their products to so many floxies, and for them to have a willing, open mind about fluoroquinolone toxicity. Their customer-service was phenomenal and I appreciate all their hard work on behalf of the floxie community very much! I also appreciate that they’re looking for solutions to complex, poorly-understood illnesses. Companies like K-PAX are part of the solution, as far as I can tell.

Again, I have no affiliation with K-PAX, and they didn’t even ask me to write this post. I’ve tried to be as open and transparent as possible, but if any of you have any questions about any of this, please don’t hesitate to contact me.

Thanks again to the K-PAX personnel and to all the floxies who were willing to try something new!

*Please note that the results of the survey may change if more people take the survey after this post is published.

 

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Progress Gained in Fluoroquinolone Toxicity Awareness

A lot of awareness of fluoroquinolone toxicity has been gained in the last few years.  In 2011, when I got floxed, the biggest facebook support group for “floxies” had about 600 members, news stories about fluoroquinolone toxicity were few and far between, and people seemed to be reluctant to share information about fluoroquinolones on their social media accounts. Today, the biggest facebook support group for floxies has almost 4,000 members (and many people have come and gone, so there have been more than 3,400 people who are aware enough of fluoroquinolone toxicity to join the group), news reports about the dangers of fluoroquinolones seem to come out on a weekly basis, and people are screaming about the dangers of fluoroquinolones in every way they can – through their social media accounts, telling their personal stories on web sites, commenting on news stories, and through talking to their families, friends, doctors and anyone else who will listen to them.

We’re making progress. We’re getting louder and stronger.

Even the FDA, the slow-moving behemoth that it is, has made some movement toward acknowledging the dangers of fluoroquinolones. In 2013 the warning label for fluoroquinolones was updated to note that PERMANENT peripheral neuropathy is a possible adverse effect of fluoroquinolones. The FDA stated that this change to the warning label was because of a review of AERS (Adverse Event Reporting System) data that found that many people were reporting disabling peripheral neuropathy as an effect of fluoroquinolones. AERS reports are patient reports. The FDA is listening to our screams.

The warning label change prompted a slew of lawsuits against Bayer (the maker of Cipro and Avelox) and Johnson & Johnson (maker of Levaquin), that hopefully will give some people justice and compensation for the harm that fluoroquinolones have done to them. Just having the door opened for justice is a step in the right direction – it’s progress.

In September, 2014 Dr. Charles Bennett filed two Citizen’s Petitions with the FDA asking them to change the fluoroquinolone warning labels to note “mitochondrial toxicity” and “psychiatric adverse effects.” The FDA’s response to those petitions is still pending, but the petitions themselves are valuable, both in that they are communications with the FDA, and that they give victims of fluoroquinolones credibility.

More than 60 news stories about the dangers of fluoroquinolones have aired in the last year. Each of these news stories was made possible by people reaching out to the news media. They wouldn’t have happened without people advocating for themselves and speaking up. With each news story, the word spreads about the dangers of fluoroquinolones, and the more people are aware of fluoroquinolone toxicity. With awareness of the dangers of fluoroquinolones comes avoidance of them, and that’s certainly progress.

One of the most influential news-stories about fluoroquinolones was “Local woman says popular antibiotic killed her husband” which aired on WSB-TV Atlanta. It had more than 135,000 social media shares, and Levaquin prescriptions in the Atlanta area dropped dramatically after it aired. It not only successfully spread the word about the devastating effects of fluoroquinolones, it changed prescription rates for fluoroquinolones. That’s huge! (Though, of course, it is horrible that Chris Dannelly lost his life. My eternal condolences to his family.)

A lot of progress in awareness of fluoroquinolone toxicity has been made through social media. When I first got floxed, people didn’t mention fluoroquinolone toxicity on their social media pages. There seemed to be a lot of silence, and even shame, around it. Now there are people who share information about the dangers of fluoroquinolones on their social media accounts regularly. With every “share” or “like” people are reached and progress toward awareness is made. Every little step rolls the ball in the right direction and gives us momentum. A huge THANK YOU to everyone who shares information about fluoroquinolone toxicity with their social network!

While it is sad to see the devastation that fluoroquinolones bring to every floxed individual, it is nice to see that the awareness of fluoroquinolone toxicity is reaching people, and that they are reaching out for support on facebook. The community of floxies helping and supporting each other in The Fluoroquinolone Toxicity Group has grown significantly. Each person who connects their health problems to fluoroquinolones is a step toward general awareness of fluoroquinolone toxicity. Everyone who joins The Fluoroquinolone Toxicity Group realizes the dangers of fluoroquinolones for themselves and their loved ones. Of course, I hate to hear of people getting hurt by fluoroquinolones, but with each new member to the group, awareness and support are gained.

Even this site has gained a lot of momentum. When it launched in 2013, Floxie Hope was getting about 5,000 visitors per month (which I was THRILLED with). Now 30,000+ visitors per month view Floxie Hope. I’m proud to be part of the movement toward awareness of the devastation that fluoroquinolones bring, and I hope to be part of movements to study fluoroquinolones and limit their use.

All of us who are telling our stories, supporting each other, and sharing information about fluoroquinolone toxicity are making progress. Thank you to all of you!

Admittedly, we have a long way to go before paradigms about the safety of fluoroquinolones shift in the general population.  There are still some doctors who are giving FQs out like candy.  There are still people who deny adverse effects of fluoroquinolones that are listed on the warning labels.  There is still a lot of research that needs to be done.  But progress has been made in the last year, and this post is to celebrate that progress.  Good job, friends!  Keep going!

 

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Repeated Use Doesn’t Make Fluoroquinolones Safe

Hormones Matter Logo

I posted “REPEATED USE DOESN’T MAKE FLUOROQUINOLONES SAFE” on www.hormonesmatter.com on 10/1/2014.  Please check it out and share it – thanks!!!

When doctors say things like, “I’ve prescribed fluoroquinolone antibiotics to hundreds of patients and I’ve never seen problems like yours. It’s a good drug with an excellent safety record.” it really irks me.  It irks me for the nine reasons listed, but the one that irks me most is that it’s so illogical.  Doing things wrong repeatedly does not make them right.  Thousands of prescriptions for Vioxx, Thalidomide and DES were written before they were taken off the market or restricted. I’m sure that the doctors who wrote those prescriptions thought that the drugs that they were prescribing were perfectly safe. They weren’t. Fluoroquinolones are not safe either. Lack of recognition of the severe adverse effects does not make them safe – it just means that doctors are as biased and blinded as anyone else. Look at the studies. Look at what Cipro, Levaquin and Avelox do to cells. Cellular destruction results in multi-symptom, chronic illness – in case that fyi is needed.

 

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Mitochondria, Neuropathy, HIV and Fluoroquinolones

mitochondria structure

I wrote the following post and put it on one of my other sites, Mito Madness.

Mitochondria, Neuropathy, HIV and Fluoroquinolones

Though the damage done by fluoroquinolones to mitochondria is well documented, as is the connection between mitochondrial damage and many illnesses and maladies, the knowledge of the connections is not widespread.  Hopefully, some emerging research will change that.

Thank you for reading it!

Regards,

Lisa

 

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Dear Doctors: There is valuable information in “Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration“

I’ve been struggling to write a “Dear Doctors” post for a while.  Everything that I’ve tried to write has been too bitter, or too manic, or too scolding, and nothing has yet been published.

I recently stumbled across a great article though, and I now have a “Dear Doctors” letter.  Here it is:

Dear Doctors,

Read this:

Journal of Investigative Medicine HIGH IMPACT CASE REPORTS, “Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration

And please change how you prescribe fluoroquinolones accordingly.

Thank you,

Lisa Bloomquist

The article is great and I highly recommend that everyone read it.  Following is my breakdown of it.  Everything that is italicized is a direct quote from “Permanent Peripheral Neuropathy, A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration” by Dr. Jacquelyn K. Francis and Dr. Elizabeth Higgins.  (Everything that is not italicized is my commentary.)  The article was published in the Journal of Investigative Medicine High Impact Case Reports and was published on July 27, 2014.

INTRO

While there has been success in recent years in decreasing the numbers of unnecessary antibiotic administrations, still rampant in medical practice is the inappropriate use of antibiotics. Fluoroquinolones administration is no different.

Indeed – fluoroquinolones are being prescribed inappropriately.  Not many people are arguing that fluoroquinolone antibiotics should be banned.  Most of us are arguing that fluoroquinolone antibiotics are used INAPPROPRIATELY, and in being used inappropriately they are causing unnecessary harm.

These bactericidal agents are capable of central nervous system (CNS) penetration, with an impressive treatment profile that includes an enhanced spectrum of activity, high oral bioavailability, high serum drug concentration that parallels that of intravenous drug administration, and rapid mechanism of action. It is for this reason that physicians favor these drugs for treatment of simple infections, which range from uncomplicated urinary tract infections (UTIs) and gastrointestinal infections to lower respiratory infections and pneumonias.

Unfortunately, they’re not APPROPRIATE for use in treating simple infections.  Fluoroquinolones are strong drugs.  They are chemotherapy drugs masquerading as antibiotics.  But doctors reach for them for simple infections because, well, these two quotes illustrate the problem well:

In The New York Times article, “Popular Antibiotics May Carry Serious Side-Effects” it was noted that, “In an interview, Mahyar Etminan, a pharmacological epidemiologist at the University of British Columbia, said the drugs were overused ‘by lazy doctors who are trying to kill a fly with an automatic weapon.’”

In “Your Doctor’s Knee-Jerk Reflex: How Not to Get Kicked” by Dr. David Katz, M.D., published in the Huffington Post, it was noted that, “Often, the easiest way for a busy clinician to be sure to ‘cover the bases’  with an antibiotic is to go after a fly with an elephant gun. The collateral damage can, predictably, be considerable; a consequence of knee-jerk prescribing.”

According to established guidelines, however, these antibiotics are recommended as drugs of last resort and for treatment of cases refractory to other safer antibiotic alternatives.

When it is uncovered that the increase in rates of fibromyalgia, autism, autoimmune diseases, diabetes, chronic fatigue syndrome / M.E., ALS, Alzheimer’s Disease, Lymphoma and other diseases since 1990 is due to fluoroquinolones, doctors will cry to the FDA and AMA about how they weren’t warned.  But they were warned.  FDA and AMA guidelines state that fluoroquinolones should only be used as a last resort and that magnesium levels should be checked prior to administration of fluoroquinolones.  Too many doctors just ignored those recommendations.

Reports in recent years of the adverse drug events of these drugs are on the rise, with not only an overrepresentation of common antibiotic complaints, including diarrhea, nausea, and headache that occur at rates higher than most other antimicrobials on the market, but there is also mounting evidence suggesting the potential for long-term adverse peripheral nervous system (PNS) effects from fluoroquinolone usage. The need for physicians to be judicious when prescribing these drugs is therefore paramount.

Patients are crossing their tolerance thresholds for fluoroquinolones.  There is only so much damage that their cells can withstand, and people are developing fluoroquinolone toxicity syndrome after crossing their cellular damage threshold.

Yes, physicians need to be judicious when prescribing these drugs.  That would be lovely.

CASE PRESENTATION

A 57-year-old Caucasian female presented to outpatient clinic with complaints of dysuria, polyuria, and urinary urgency. Urinalysis showed 2+ leukocytes and trace blood. Based on her clinical presentation, she was treated for UTI with a ciprofloxacin regimen of 250 mg twice a day for 5 days. Subsequent urine culture showed no evidence of organism, and against advice for reevaluation, she was lost to follow-up. She presented 2 months later reporting whole body burning and alopecia. The burning, she claimed, started 2 or 3 days after completion of the prescribed course of ciprofloxacin. The burning lasted 3 weeks and resolved only to recur, unrelentingly, 3 weeks later. She had been unable to adorn clothing during this time, for she said this triggered whole body burning. At the point wherein she was finally able to wear clothing, she presented to the clinic. Hydration and Epsom salt soaks provided no relief. She reported pain of 10/10.

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Note that the patient DIDN’T EVEN HAVE AN INFECTION.  She was poisoned with ciprofloxacin when there wasn’t even an infection.  Talk about INAPPROPRIATE!  Criminal is more like it!

Her peripheral neuropathy pain was so bad that she was “unable to adorn clothing during this time, for she said this triggered whole body burning.”  THAT. IS. HORRIBLE!  A pain level of 10/10 is what she experienced.  That is a SEVERE adverse reaction and even the possibility of a reaction like that should dissuade doctors from prescribing fluoroquinolones frivolously.

She didn’t even have an infection.  It boggles my mind.

Her past medical history is significant for trigeminal neuralgia, in remission for 12 years. The patient was on no medications at the time of her visit. She has no specific medication allergies, but does get gastrointestinal symptoms with opioids, namely, fentanyl. Physical examination was unremarkable. Vitals at the time that she was seen included the following: blood pressure 132/78 mm Hg, temperature of 97°F, heart rate of 60 beats per minute, respirations of 18. Her body mass index was 17.94, down from 20.3 two months earlier. On detailed neurologic examination, cranial nerves II through XII were intact bilaterally. There was no pronator drift of outstretched arms. There was some muscle wasting in biceps; however, overall tone was normal. Strength was full bilaterally. Reflexes were 2+ and symmetric at the biceps, triceps, knees, and ankles. Plantar responses were flexor. Light touch and pinprick produced pain and paresthesias diffusely in the upper and lower extremities; however, position sense and vibration sense were intact in fingers and toes. Rapid alternating movements and fine finger movements were intact. There was no dysmetria on finger-to-nose and heel-knee-shin. There were no abnormal or extraneous movements. Romberg was absent. The patient’s posture was normal. Gait was steady with normal, though tentative, steps, base, arm swing, and turning. Heel and toe walking were normal. Tandem gait was normal. She had no discernable rash or skin lesions.

Subsequent complete blood work analysis to check for an electrolyte abnormality basis of her complaints was unremarkable. Her complete blood count was normal with a hematocrit of 41%. Her vitamin B12 level was 258 pg/mL, with a normal range of 200 to 900 pg/mL. Her thyroid stimulating hormone level was 2.05, with a normal range of 0.4 to 6.0. Her immunoglobulin levels were normal. Her vitamin D level was 13 nmol/L (optimal >30 nmol/L). Copper level was 98 mg (normal 50-80 mg). Vitamin E was normal at 12.7 µg/mL (normal range = 5.5-17 µg/mL). Vitamin B1 was normal at 5.4 µg/dL (normal range = 2.5-7.5 µg/dL).

Her blood work and further questioning could provide no new medical etiology for her symptoms, and so the patient was subsequently sent for complete neurological workup. Workup included heavy metal toxicity screening to assess for possible heavy metal exposure to lead, mercury, cadmium, and zinc. Electrophysiological studies were also done to assess neuromuscular nerve action potential transmission, a test that could discern a neuromuscular disorder etiology. Three-millimeter skin punch biopsy to assess for small fiber density and possible neurologic process were also done. These tests were all negative. Neurological workup could not determine a unique cause of her symptoms. It was concluded that if her symptoms were neurologic-based, it was, in fact, a multifocal process.

Fluoroquinolone toxicity syndrome has been unrecognized for so long for many reasons.  One of the biggest reasons is that the tests all come out “normal.”  This simply means that the tests are wrong.  If a patient has pain levels that are a 10/10, there’s something wrong with her and if the tests don’t show it, the tests aren’t sufficient.

Two years after the initial onset of symptoms, the patient continues to suffer from polyneuropathies chronologically related to ciprofloxacin use. At her most recent visit, she describes constant pain of 7/10 and is unable, she states, to ambulate for more than 2 minutes, without intense shooting pains up and down her lower extremities. She describes “pins and needles” up and down her legs and thighs radiating to her buttocks and feet. She claims that her upper body and abdomen have now been spared of such feelings. She describes severe alopecia and ambulates now with a broad-based gait. She describes being on permanent disability because of her condition. The rest of her physical examination remains unchanged. There are no gross neurological deficits discernible on neurologic examination. The patient remains on amitriptyline 20 mg daily for control of her pain symptoms.

This patient’s life has been ruined.  My heart goes out to her.  Two years later, she still suffers from chronic pain and is now disabled.  THIS IS NOT OKAY.

DISCUSSION

Fluoroquinolones are fluorinated quinolones, the only bactericidal agent in the antibiotic class capable of directly inhibiting DNA synthesis.

Fluoroquinlones may not be the only antibiotics that damage mitochondria, but they are the only antibiotic class that inhibits DNA synthesis.  And who, exactly, thought it would be a good idea to give people drugs that inhibit DNA synthesis?

The harm that fluoroquinolones do to DNA shouldn’t come as a surprise.  It was noted in “Quinolone binding to DNA is mediated by magnesium ions” in 1992 that, “Even if reconsidered in terms of affinity, the interaction with DNA is still of great concern because of the possible long-term genotoxicity of quinolone compounds, which are increasingly adopted as first-choice antibiotics for the treatment of many infections, and because it addresses the real mechanism of action for this class of molecules.”

Caution was warranted.  It was not used.

They do this by promoting cleavage of bacterial DNA in the DNA–enzyme complexes of DNA gyrase and topoisomerase IV.  Generally, gram-negative antibacterial activity correlates with inhibition of DNA gyrase, and gram-positive antibacterial activity corresponds with inhibition of DNA type IV topoisomerase.  With the introduction of these drugs in the 1960s, physicians were able, for the first time, to treat severe gram-negative infections orally. The first successful fluorination of part of the quinolone drug in 1986, in the form of norfloxacin, brought with it the capability of crossing the blood–brain barrier and achieving CNS penetration.

Fluoroquinolones have the capacity to cross the blood-brain barrier and achieve CNS penetration.  NOT GOOD.

This and the already great treatment profile in the form of enhanced spectrum of activity, high oral bioavailability, high serum drug concentration comparable to intravenous infusion, and rapid mechanism of action added to the popularity of these drugs ultimately resulting in the indiscriminate use of these drugs. The enhanced treatment profile of these drugs came at a price however, with adverse effects so severe that use of many fluoroquinolones since then being restricted or the drugs withdrawn from the market entirely.

These drugs have been used indiscriminately at a huge price.  If, as I suggested above, the increase in chronic, debilitating, mysterious diseases that has come about since 1990 is, indeed, due to fluoroquinolones, the “price” of these drugs is even greater than what the study’s authors have noted.

One of the challenges of diagnosing a patient with fluoroquinolone-associated peripheral neuropathy is the diffuse, confusing, and delayed array of symptoms that can occur. A 1996 study first brought these adverse effects to light.

I could cry.  Delayed adverse reactions are noted in a journal article.  The fact that symptoms are diffuse, confusing, and difficult to diagnose is acknowledged in a journal article.  E-hugs to Dr. Francis and Dr. Higgins.

While patients on the fluorinated drugs exhibited less side effects than those associated with first-generation quinolone predecessors, such as nausea and gastrointestinal disturbances, 0.9% to 1.6% experienced adverse reactions relating to the peripheral and central nervous system, including headache, dizziness, drowsiness, agitation, psychosis, and convulsions, as well as peripheral sensory disturbances, symptoms that had never been complained of prior, at least not on any significant scale.

It is not okay to induce possibly permanent nervous system damage in .9 to 1.6% of those who take fluoroquinolones – especially when the nervous system damage can be permanent.  26.9 million prescriptions for fluoroquinolones were written in 2011 alone.  .9% of 26.9 million is 242,100 and 1.6% of 26.9 million is 430,400 – PEOPLE.  Between 242,100 and 430,400 people had adverse central and/or peripheral nervous system side-effects.

Note that peripheral nervous system damage from fluoroquinolones could easily be mistaken/misdiagnosed as fibromyalgia, and central nervous system damage can lead to depression, anxiety and other psychiatric illnesses.

Of these patients, 81% had symptoms occurring within 1 week of drug administration, with paresthesia being the mainly reported symptom. Five years later, a 2001 study found that contrary to previous reports suggesting that fluoroquinolone-associated PNS events are mild and short term, 80% of study participants reported severe events that typically involved multiple organ systems, especially the PNS, with symptom onset as early as 24 hours within initiation of treatment. 58% of these cases had symptoms lasting greater than 1 year.

Indeed.  My thanks to the authors of this paper for noting that peripheral nervous system adverse reactions to fluoroquinolones are neither mild nor short term.  Compared to other floxies, my reaction was moderate – and I still had pain for more than a year.

Another 2001 formal study that sought to assess the prevalence of fluoroquinolone-induced PNS adverse side effects highlighted the severity of these effects. The study concluded that there was a high association between fluoroquinolone antibiotics and severe, long-term adverse PNS and multiple organ system effects that included PNS sensory symptoms (91%), peripheral neuropathy motor symptoms (55%), and CNS effects (75%). Over 80% of the patients surveyed had sequalae stemming from fluoroquinolone use that lasted for greater than 1 year.  A subset of these patients and their adverse drug events are included in Table 1.

Risk is a function of frequency and severity of adverse reactions.  Adverse reactions to fluoroquinolones are severe.  I don’t think that they’re rare (https://floxiehope.com/2013/08/09/is-fluoroquinolone-toxicity-rare/).  Fluoroquinolones are far too risky to be used as they are currently being used.

Despite these seemingly significant numbers and overwhelming reports from patients, physicians continue to prescribe fluoroquinolone antibiotics unsystematically, against US Food and Drug Administration recommendations. The pressures of health care facilities and patients alike to increase patient turnaround and quickly alleviate symptoms may compound this problem. 

Dear doctors – please, please, please listen.  Please listen to your patients, listen to the AMA and the FDA, and listen to your colleagues who wrote this case-study.  We see that fluoroquinolones are dangerous drugs and we are trying to tell you about them.

As highlighted in the aforementioned case, the peripheral neuropathy reported with fluoroquinolone administration can be severe, debilitating, and permanent. It is for this reason that physicians need to practice due diligence when prescribing not only antibiotics, but any drug.

THANK YOU Dr. Francis and Dr. Higgins!

Physicians also need to practice vigilance in the event of an adverse reaction. They can do this with careful follow-up of patients and ensure that patients are aware of all the side effects that may be associated with their prescribed drug. Patients need to know what to look for and where to go in the event that one of these symptoms become manifest. It is our hope that the updated FDA warning and presentation of this case will encourage physicians to be more conscientious of their treatment selections.

Yes, we need recognition and an appropriate treatment protocol for everyone suffering from fluoroquinolone toxicity.  Thank you for saying it so well, Drs. Francis and Higgins!

TAKE HOME POINTS

  • The FDA recommends that fluoroquinolones be used as a drug of last resort and for treatment of cases refractory to other safer antibiotic alternatives.
  • The FDA updated their black box warnings on all fluoroquinolones to stress the rapidity of onset and permanence of peripheral neuropathy associated with their use.
  • Physicians should be aware of the risks and side effects associated with the drugs that are prescribed and be able to inform patients of the risks associated with the use of these drugs.
  • Physicians should always aim to administer the least broad spectrum antibiotic possible based on known sensitivities and regional resistance PATTERNS.

I know that I’m incredibly biased, but I think that the tide is shifting.  I think that the severity of adverse reactions to fluoroquinolones are being recognized.  With recognition will come change in their behavior.

I hope for change.

 

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Fluoroquinolone Antibiotics Damage Mitochondria – FDA Does Little

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The Pharmacovigilance folks at the FDA know that fluoroquinolones are damaging mitochondria.  Yet, they look the other way.  Adding a more severe warning about peripheral neuropathy to the warning label isn’t helpful.  People should know that they are increasing their risk of every chronic disease associated with mitochondrial damage and oxidative stress when they take a fluoroquinolone.  That would actually be helpful.

Here is the post, on Hormones Matter – http://www.hormonesmatter.com/fluoroquinolone-antibiotics-damage-mitochondria-fda-adds-warning/

 

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Saving the Life of a Floxie

I think that it’s really important to have someone who saves your life early in your Floxing.

Everyone’s Floxing/Fluoroquinolone Toxicity is different.  Some people start having aches and pains after taking a fluoroquinolone and those aches and pains gradually build over time as their tendons get weaker and weaker, their cartilage thins and their nerves get more exposed.  The people with gradual onsets of fluoroquinolone toxicity problems are probably unlikely to realize that the causes of their issues are the antibiotics that they took at some point in the past.  They are more likely to attribute their pain to aging, Fibromyalgia, arthritis, etc.  Other people’s fluoroquinolone toxicity comes on suddenly.  They go from being healthy and active, to being suddenly unable to walk, sleep, think or do any of the activities that they enjoyed just weeks earlier.  Those people tend to freak out – as is a reasonable thing to do when, without warning, everything in your body is going hay-wire.  All Floxies deserve help as they go down the path of being poisoned, and recovering.  Those with a sudden onset of physical and mental health issues very much need help as they go, suddenly, from being healthy and active to barely able to move.

Fluoroquinolone Toxicity is frightening to experience.  To go from being able to easily run 5 miles to barely being able to walk, is scary.  To have pain that travels throughout your body, for no apparent reason, is scary.  To lose your memory, your ability to connect with other people, your ability to read, your ability to sleep, your sanity, etc. is scary.  All of those things happening at once, is TERRIFYING.  Add the fact that excessive fearfulness is a CNS related symptom of fluoroquinolone toxicity, and you get some people who really, really, desperately need help to make it through.

We need people to save our lives.  Perhaps that sounds dramatic.  Perhaps it is.  But it certainly doesn’t feel overly dramatic when you are going through having a bomb go off in your body.

Most people go to their doctor first.  I’m sure that there are plenty of Floxies who have been helped, and saved, by their doctors.  But generally, there is not a lot that Western Medicine can do to help people going through Fluoroquinolone Toxicity, so MDs are left to either turn away patients with FQ toxicity, or misdiagnose them.  The rejection that Floxies face from their doctors, the people that they go to first to help them, to fix them, is painful.  Not only is everything going wrong in their body and mind, but there is no solution that can be offered by the people who gave them the poison that hurt them.  (The promise of every pharmaceutical ad ever seen on TV of, “see your doctor immediately if ____ occurs,” is broken.)  It’s heartbreaking.  Sometimes the heartbreak of the disappointment is compounded by doctors being hostile or disrespectful to the Floxie, accusing him or her of having mental problems or of being a conspiracy theorist.  I won’t forgive those doctors who make sick people feel worse by blaming them for their illness.  However, I actually feel sorry for many doctors in the situation of not knowing how to heal or fix a Floxie.  They have no tools with which they can fix the mess that their drugs made.  They have little knowledge of the effects of these drugs, much less the mechanism by which they operate – they only know that they kill bacteria and that they typically don’t immediately kill people.  They have little time and a lot of pressure.  The Western Medical System is not set up for doctors to save lives (with the exception of emergency medicine), or to heal people.  It is set up for doctors to “fix” ailments by throwing drugs at people, and both patients and doctors suffer as a result.

When doctors aren’t able to provide help, help is sought elsewhere.  And when it is found, it is a God-send.  We truly NEED our lives to be saved.  We need someone to prop us up, to let us know that we will be okay, that we can make it, that life isn’t over – in a way that we can hear, in a way that we can know and truly believe.

My Acupuncturist saved my life.  The needles that he put in me didn’t save my life, though I think they helped.  The herbs that he gave me didn’t save my life, though I felt better because of them.  HE saved my life.  He treated me when others weren’t able to.  He gave me a diagnosis.  He treated every new symptom that popped up, they popped up daily for a while, and he saw me as often as necessary.  He stopped the downward spiral that my body was intent on for a while.  He stabilized my physical, mental and emotional health.  He made me realize that healing was possible.  He never downplayed a symptom and he always believed me, but he would still tell me when I was being silly, wrongheaded or self-destructive.  When I lost my memory and reading comprehension and asked him, “What if I’m stupid now?” he responded, “But you’re not,” and it meant the world to me.  Because I trusted him.  He knew how to treat my body, mind and spirit.  He knew what to say and he knew what to do.  He is a healer and he was able to help me to heal.  I am eternally grateful to him.

Other people are saved by their Chiropractor or Naturopath or other Alternative Medicine provider.  Fortunately, Alternative Medicine is more set up for healing, and listening to patients, than Western Medicine, and help with healing can be found within those systems.

Other people have their life saved by a family member who recognizes the crisis that his/her loved one is in, and drops everything to help them.

Other people have had their lives saved by strangers.  They reach out, in a crisis, to people over the internet, and sometimes a guardian angel comes through and helps them, saying whatever needs to be said to let the panicked Floxie know that she/he will be okay, that she/he will make it, that the crisis will pass.

Life-saving help can come from anywhere.  It can come from a person who you know well or it can come from a person who you’ve never said a word to.  It can come from a doctor’s office or a church or a Facebook group.  It’s there though.  You might have to look for it.  You might have to ask for it, but it is there – and most people are happy to help if they can.

Those people who help Floxies through the toughest times, are so, so, so important, and I am grateful for every single person who has understood, who has helped, who has guided and who, somehow, maybe even without them realizing it, has saved a life.

Thank you.

 

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Legal Compensation for Fluoroquinolone Toxicity

I was floxed in the last months of 2011.  (I took the Cipro in November but didn’t react until December so my flox-iversary is debatable.)  For most of the time that I have been a “Floxie” the general word among fellow Floxies was that lawyers weren’t accepting fluoroquinolone toxicity cases.  It was only after the August, 2013 adjustment to the FDA warning label accompanying fluoroquinolones, that added the warning of permanent peripheral neuropathy, that I even heard of lawyers accepting fluoroquinolone toxicity cases.  Now there are at least 2 law firms that are taking fluoroquinolone toxicity cases.  I appreciate them both so I’m going to plug them:

Red Law, LLP

(310) 917-1070

http://www.redlawllp.com/

and

Nidel Law

(202) 558-2030

http://www.nidellaw.com/

There are a million personal reasons why you may or may not want to pursue legal recourse and I respect all of them.  It’s a very personal decision and I am not trying to pressure you in any way.  I do want to make sure that you know that the option is available though.  Both of the firms listed above are taking cases.

I have no reason to think that either firm is better than the other.  I have been in contact with both the Red Law attorneys and Chris Nidel, the principal at Nidel Law.  They all seem competent and professional.

Legal pursuits are probably the only way that the system is going to change; that people are going to stop being needlessly poisoned by fluoroquinolone antibiotics.  It’s not your responsibility to be part of the change in the world that keeps others from getting hurt, but it may be some consolation as you go through the pain of a lawsuit.

I could complain ad nauseam about how the legal system isn’t set up to compensate victims of fluoroquinolone toxicity, but I’ll refrain because it’s pointless.  We have to start with where we are, with the system as it is.  I wish you all the best of luck in getting your cases accepted, getting the compensation that you deserve, and changing the world for the better.

 

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Email to the FDA

For the record, this email was sent to stephen.king@fda.hhs.gov on 10/11/2013.

Dear Mr. King,
When is it going to be recognized that fluoroquinolones are dangerous enough to severely restrict their use?  How many people have to suffer from permanent disability before their use is restricted to life-or-death situations in which there is no safer alternative treatment?
I thank you and the FDA for finally, after 30 years of complaints, updating the warning label for fluoroquinolones to include the risk of permanent peripheral neuropathy.  As someone who was severely adversely effected by Cipro in 2011, at the age of 32, who had extreme pain in my hands and feet, though I probably didn’t categorize them as “peripheral neuropathy” because I didn’t know the term until recently so my report to the FDA didn’t include that symptom, I found the label update to be somewhat vindicating.  However, it does not go near far enough.
Please consider the following:
  1. This article in Nature (http://www.nature.com/nature/journal/v501/n7465/full/nature12504.html) links topoisomerase inhibitors to the expression of Autism related genes.  As I’m sure you know, fluoroquinolones are topoisomerase inhibitors.
  2. Fluoroquinolones adduct to bacterial DNA, as described in this article – http://www.jbc.org/content/273/42/27668.full.  Please see the attached note from a retired toxicologist who was severely adversely effected by a fluoroquinolone, for a description of how fluoroquinolones adversely effect human DNA.  These drugs adduct to DNA, just like Agent Orange, and they are given out like candy.
  3. Recent media articles about how people have suffered severe CNS damage after being in the ICU.  Fluoroquinolones are utilized commonly in the ICU.  Perhaps it would behoove you to make the connection between the NEJM article noting that people stop being able to think after a visit to the ICU and the severe CNS effects of fluoroquinolones.  https://www.google.com/#q=nejm+patient+in+intensive+care+lose+memory  Also, Lynn Spalding, the patient who was being treated for a urinary tract infection whose body was found in the hospital stairwell was more than likely given fluoroquinolones to treat her UTI.  A severe adverse reaction could have caused the events that led to her death – http://www.cnn.com/2013/10/09/justice/body-in-hospital-stairwell/
  4. Please read the comments under the NYT article about the dangers of fluoroquinolones.  http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/?_r=1  NONE of these people are lying or exaggerating.  In fact, many have reactions that are more severe than they describe because it is quite difficult to verbalize your problems when EVERYTHING is going wrong in your body and mind.
If you have any desire to read my story, it can be found at www.floxiehope.com.  I have recovered, but my recovery does not make the fact that I was hurt (possibly on a DNA level) justified.  My urinary tract infection could have, and should have, been treated with a milder antibiotic.
The FDA is supposed to be protecting and informing patients.  Please move in that direction.
Please feel free to contact me if you have any questions or concerns.
Thank you,
Lisa Bloomquist
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Fluoroquinolone Antibiotics and Nerve Damage/Malfunction

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This post about how fluoroquinolones are associated with Central, Peripheral and Autonomic Nervous System Damage was published on Hormones Matter on 09/09/2013.  

http://www.hormonesmatter.com/fluoroquinolone-antibiotics-associated-with-nervous-system-damage/

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Permanent

I really appreciate that the FDA has put the word “permanent” on the warning labels of fluoroquinolones.  “The nerve damage may be permanent” is now stated under the peripheral neuropathy section of the side-effects listed.  Permanent.  Physicians may take note; they can do permanent damage to their patients with these drugs.  It may make them think twice.  It may make them realize the severity of the adverse effects of fluoroquinolones.  They may see that they can do damage with these drugs that they can’t fix.  Permanent damage.

While it is wonderfully validating to see the words “The nerve damage may be permanent” on the updated label for Cipro, there’s a part of me that hates that word – permanent.  It’s a word that steals people’s hope.  It’s a word that feeds into fear, hopelessness and suicidal ideation. It’s a word of doom.

You are not doomed.  There is nothing about you that is permanent.  Nothing is permanently damaged.  Nothing is permanently perfect.  We are all in a state of flux, all the time.  Sure we’re all decaying a bit, it’s the nature of living things, but we are also growing and healing.  People recover from this.  They do.  I did.  Lots of other people have recovered too.  There are stories of hope and healing on this site.  Sure, it’s not a huge number of stories right now, but the site has only been up for a couple of months and, well, the people who have healed have moved on with their lives.  If I may be so audacious, I would say that MOST people recover, with time.  It’s a really long, rough, painful, scary road, but people get down it.  People get to the end.  They recover.  I hope that you can find the strength to believe that you will recover too.  If you can’t find that strength today, I hope that you can find it tomorrow.  Because this life is worth fighting for.  Not only your health, but your hope and your spirit are worth fighting for as well.

As someone said in one of the fluoroquinolone victim support group sites, “no side effect can be proven permanent until you’re dead.”  True.

So hang in there folks.  I know that it’s a trite thing to say, and I apologize for that, but I mean it.  Just take one breath at a time.  You can get through this.  Bayer and Johnson & Johnson may have kicked you, but they didn’t kill you.  You’re still here.  You can recover.  Have hope.  Try.  ‘Cause it’s only permanent if it kills you, and it didn’t.

 

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FDA Announces that Permanent Peripheral Neuropathy is to be Added to Warning Labels for Fluoroquinolone Antibiotics

 Essay #1

On August 15, 2013 the FDA announced that a new, highlighted warning would be added to all orally administered and injected fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, etc.), noting that these drugs cause peripheral neuropathy.  The announcement can be viewed through this link – http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm The Related Information links give further details on the dangers of fluoroquinolones and the rationale behind the FDA’s decision to finally, after 30 years of consumer complaints, to warn people of this devastating effect of fluoroquinolones.

The FDA announcement is a HUGE step in the right direction. Now, when patients go to their doctors with sudden, severe pain in their extremities, their doctors are going to be more likely to connect the patient’s peripheral neuropathy with the fluoroquinolone antibiotic that the patient took.  As more and more doctors make the connection between their patients’ painful, burning, swollen feet (among other symptoms of peripheral neuropathy) and fluoroquinolones (again, Cipro, Levaquin, Avelox, etc.), they will be more likely to recognize the severity and frequency of adverse reactions to these drugs.  They may even start connecting the other symptoms that their patients experience with fluoroquinolones and really, truly acknowledging the damage that these drugs do.  This recognition may/should/will start the ball rolling in the direction of doctors actually using fluoroquinolones appropriately – as a drug of last resort, to be used only in life-or-death situations.

At the very least, this new warning increases the likelihood of a correct diagnosis from a doctor for those who are suffering from Fluoroquinolone Toxicity Syndrome.  When I went to my doctor with swollen, painful, weak hands and feet (and hives all over my body), she told me that it wasn’t possible that my issues were from the Cipro that I had taken 2 weeks earlier.  She was wrong.  Now that this warning label has been added, it is less likely that she’ll misdiagnose the next patient who comes to her with similar symptoms.  She is more likely to realize that Cipro, Levaquin, Avelox and other fluoroquinolones are dangerous drugs with severe consequences to the health of her patients.

The doctors who connect the peripheral neuropathy that their patients experience with  fluoroquinolones will be more likely to report the adverse reaction to the FDA.  As more and more reports of adverse effects of fluoroquinolones are reported, it is more likely that the real risks of these drugs are properly established, by the FDA and physicians alike.  Once risk is properly established, a more reasonable protocol for their use can be established.

As someone who has suffered through Fluoroquinolone Toxicity Syndrome and peripheral neuropathy caused by Cipro (taken to treat a simple UTI), I’m thankful for the FDA’s acknowledgment of the peripheral neuropathy that people experience as a result of fluoroquinolones.  Really, I’m grateful for the move in the right direction.  But there are some things that bother me about the announcement.

First, they state that, “The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.”  Really, FDA?  You think that these drugs applied in the ears and eyes don’t have devastating system-wide effects?  Fluoroquinolone ear and eye drops are typically in low enough doses that Flouroquinolone Toxicity Syndrome doesn’t result, but don’t you still think that the people who take the ear and eye drops (or administer them to their children) should at least know that these drugs cause permanent peripheral neuropathy when administered in another form?  It seems appropriate to at least make some sort of note about this serious side-effect, especially when these drugs are given to children to treat ear infections.  The specialist model of the Western medical system that treats each part of a body as separate and as if it doesn’t connect with the rest of the body, is absurd.  If a drug is dangerous when administered orally, it’s pretty likely to be dangerous when put into the eye.  It just seems negligent to not warn people of the adverse effects of a drug in all forms in which they’re available.

Second, they state that, “If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.”  Well, at least the standard instruction of “finish the entire course of antibiotics” is abandoned.  Instructing people to finish a course of a drug that they’re having a severe adverse reaction to is bad advice, to say the least – and it was standard protocol for years.  But there is the implication that if the patient stops taking the fluoroquinolone, the ceasing of taking the drug will help to stop the reaction that is causing the peripheral neuropathy.  Unfortunately, this isn’t the case.  At least the FDA mentioned that the peripheral neuropathy can be permanent, so the fact that it won’t be fixed by cessation of taking the drug is at least acknowledged.

The warning of peripheral neuropathy is the third highlighted warning on fluroquinolones.  The other two are for death in those with myasthenia gravis and tendon ruptures (for everyone, not just those with  myasthenia gravis).  Now that peripheral neuropthy is added to the list of side-effects that are severe enough to require a highlighted warning, maybe people will start realizing that these are dangerous drugs, and maybe doctors will start following their Hippocratic Oath and stop prescribing them in cases where other, safer antibiotics can get rid of the infection just as well.

Essay #2

On August 15, 2013 the FDA announced that a new warning label is to be added to all orally administered and injected (via IV) fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin, etc.) warning people of the serious side-effect of peripheral neuropathy.  The FDA announcement notes that peripheral neuropathy is serious nerve damage and that it can be permanent.

http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm

As someone who took Cipro and subsequently experienced painful peripheral neuropathy, I’ve got to say that this validation from the FDA feels pretty darn good.

As most sensible people would, I went to my doctor when I broke out in hives all over my body, my hands and feet were swollen and painful, my tendons throughout my body were tight and my legs were so weak that I could barely stand.  I was told that they didn’t know what was wrong with me.  As far as missed diagnosis’ go, “I don’t know” is a pretty benign one, so I’m thankful for it.  I could have been incorrectly told that I had Rheumatoid Arthritis or a number of other diseases that my symptoms mimicked (M.S., Lupus, Fibromyalgia, Lyme Disease, Chronic Fatigue Syndrome, Leaky Gut Syndrome, etc.).  When I asked my doctor if it was possible that the Cipro that I had taken prior to the emergence of my symptoms, she told me that it wasn’t possible.

It’s not only possible, it’s true.  The FDA announcement confirms what I already know to be true – Cipro caused my peripheral neuropathy (and all my other health problems, but the FDA hasn’t confirmed that yet).

VINDICATED!  After 20 months of health issues caused by Cipro, an ANTIBIOTIC I took to treat a simple urinary tract infection, the FDA finally confirmed that the peripheral nerve damage that I suffered from was caused by the pharmaceutical I took, the so-called medicine.

Perhaps someday the FDA will put a highlighted warning on fluoroquinolone antibiotics about the CNS damage that they can cause.  Yup, CNS damage.  That’s brain damage, folks.  A petition is circulating to get a warning of the risk of CNS damage added to the labels of all fluoroquinolones.  Please sign it – http://www.change.org/petitions/food-and-drug-administration-department-of-health-and-human-services-black-box-warning-for-fq-drugsand-cns-damage  People deserve to KNOW about the devastating, sometimes permanent, adverse effects of these drugs.

There are now three highlighted warnings on the labels for fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin, etc.)  One warning of increased risk of developing tendonitis and TENDON RUPTURE, another warning of DEATH in patients with myasthenia gravis, and now another warning for possible permanent PERIPHERAL NEUROPATHY.  Additionally, the FDA is being petitioned by consumers who have suffered from brain damage to add CNS damage to the list of warnings.

Do ya think that there may be a problem with these drugs?

Yes, there’s a problem with these drugs!  And given the rampant use of them, 26.9 million people were either given fluoroquinolone pills or IVs in 2011 (per the FDA) and the rate of adverse reactions ranges from 4.4% to 20% (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/?report=printable), it’s a BIG problem!  Do the math, you’ll find that one to five million people were adversely effected by these drugs in 2011 alone.  Adverse reactions can range from an annoying but harmless eyelid twitch to body-wide breakdown and PERMANENT PERIPHERAL NEUROPATHY, TENDON RUPTURE and even DEATH.

Serious policy changes need to be enacted around these drugs.  They can sometimes be necessary to save a life and therefore they shouldn’t be banned.  But maiming and disabling people with a class of antibiotics when there are other, safer antibiotics available, is ABSURD and it’s WRONG.

The new warning is a good start, but we need you to keep going, FDA.  Do what should have been done years ago.  The research is out there.  Pay attention and do what’s right.  Please.

A song – 

 

 

Warning Signs of Fluoroquinolone Toxicity

Almost every time I mention how Cipro messed me up, I get the response, “Oh yeah, I’ve taken that – it doesn’t affect me.”  To which I respond, “I took it several times before I reacted to it too. My body went completely hay-wire the second time I took Cipro. Don’t take it again.”

Adverse reactions to fluoroquinolones aren’t allergic reactions, they’re something else. The pathology of adverse reactions to fluoroquinolones is unknown – to anyone (or, if someone knows, they’re not publishing research papers about it). My guesses to the pathology can be found at https://floxiehope.com/2013/06/20/what-is-fluoroquinolone-toxicity/.

Unlike allergic reactions, adverse reactions to fluoroquinolones often occur long after the fluoroquinolone use has stopped. Antihistamines do nothing to stop an adverse reaction to a fluoroquinolone (though they may be able to help with some of the inflammation symptoms and they don’t seem to hurt most Floxies).

Though some people react to their first dose of a fluoroquinolone, many don’t, which leads them to falsely believe that these drugs are safe and that they won’t react to them in the future. Unfortunately, an adverse reaction to a fluoroquinolone can occur even if (maybe especially if – because there is (anecdotal) evidence that fluoroquinolones accumulate in the body and that there is a “tipping point” at which the body overloads) they have been taken with no adverse reaction in the past.

Looking back, I had some of these warning signs after I took Cipro the first time, in 2010. My eyelid twitched and I developed strange, but passing, abdominal cramping.  I experienced a “weak bladder” that I attributed to genetics and age. I had itchy legs at times and just thought it was dry skin. I didn’t connect any of these things to the prescription antibiotics that I took to treat a urinary tract infection.

If I had connected those symptoms to the fluoroquinolones, I may have been able to avoid taking Cipro again, and I may have avoided the pain and suffering that I went through starting in December, 2011.  (https://floxiehope.com/lisas-story/). I hope that this list of minor symptoms serves as a warning to you.  Please don’t take any fluoroquinolone antibiotics no matter what, but especially if you are experiencing any of the following, heed your body’s warnings and stay away from these drugs!

What FQ can do (HINTS AND CLUES THAT MIGHT SAVE YOUR LIFE)

Perhaps you have taken quinolones in the past and you think that they worked well and that you did not react negatively to them. Check the following subtle symptoms of the beginning stages of a quinolone intoxication from an earlier treatment and the normal interpretations that people make of them.

* You had a strange bout of tendinitis, for instance in the outer tip of the hip, normally diagnosed as trochanteric bursitis caused by tight belts or resting on you side at night. The same applies to other areas of the body, like the elbow (epicondylitis) diagnosed as an overuse of your tennis racquet or gardening practices, but you remember that you had never had it before.

* It takes you longer to recover after exercise. It is not alarming and you have not paid much attention to it.

* You sleep worse than before; it seems normal as you have a lot of pressure at work.

* From time to time you have some small throbbing pains in different parts of the body. They last only for a few seconds, so there is nothing to worry about it.

* It is strange- but you have occasional twitching in an eyelid, or any other part of the body. It is not painful.

* Some nights you feel some mild itching migrating along your body. One brief itch here, and another there. It is more intense in the scrotum or groin. Instead of identifying it as a peripheral neuropathy, you conclude that your clothes, your perspiration or the new brand of soap that is more irritating must be causing it.

* You feel some stiffness, and your range of movement is not as full as before, especially in one or both legs, but it is normal because you are getting older.

* You do not tolerate coffee as well as before. Now you have to reduce the amount of coffee that you used to drink.

* Your memory is not as good as it used to be. The cause may be too many things to think about and too much stress. And you are no longer a young person.

* There is an urge to urinate when the bladder is partially full. When you feel the need to urinate you have to rush for the toilet. Most urologists think that it is due to a dysfunction associated with a benign enlarged prostate but in reality it is a neurological deficit caused by the prescriptions of quinolones that they gave you.

* You cannot flex fully, or strongly, your big toe (one or both), or sustain the flexion for more than a few seconds. This is an indication that your large nerves (anterior tibialis) have started to fail due to the toxicity. This sign is a strong warning that your body will not tolerate more quinolones.

* Sometimes, you have nightmares while falling asleep that scare you. How strange you think. They are toxic panic attacks that reflect toxic damage to your brain.

If you have experienced some of these symptoms since you took your first quinolone, perhaps you have reached your first threshold of tolerance, that -once surpassed- can result in the destruction of your life soon thereafter if you take more quinolones.