Fluoroquinolones and Statins: A Recipe for Rhabdomyolysis

In May, 2017, WSB-TV 2 Atlanta aired the story, “Clark Howard says near-fatal disease possibly caused by popular antibiotic,” in which the story of how Clark Howard, a popular consumer expert and host of the nationally syndicated Clark Howard Show, was hurt by a combination of ciprofloxacin (a fluoroquinolone antibiotic) and generic Lipitor (a statin). Mr. Howard had a severe and life-threatening reaction to these drugs, and he is quoted in the story as saying, “I felt like death,” and “It was a struggle to walk five steps.” Mr. Howard was admitted to the hospital where he was diagnosed with rhabdomyolysis–a condition where muscles break down rapidly, causing severe strain on the kidneys and, potentially, death.

Both fluoroquinolones alone, and fluoroquinolones combined with statins, have been documented to cause rhabdomyolysis.

Here are some articles about fluoroquinolone-induced rhabdomyolysis:

Here is a news story about Chris Dannelly, who was killed after levofloxacin-induced rhabdomyolysis:

Additionally, here are some articles about fluoroquinolone plus statin induced rhabdomyolysis:

Both fluoroquinolones and statins are known to damage mitochondria, and they are both fluorinated drugs. They are also both widely prescribed–to millions of people annually–often concurrently.

In the article “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population” a description of the basic science behind fluoroquinolone-induced muscle damage (and rhabdomyolysis) is described. The following is a quote from “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population“:

Muscle: Basic Science

Although the etiology of fluoroquinolone-associated muscle disorders has yet to be fully elucidated, evidence supports a relationship with both latent myopathic disorders and the fluorine atom in fluoroquinolones. Despite no history of myopathy, an electromyogram (EMG) performed on a 54- year old woman with apparent ofloxacin-induced rhabdomyolysis demonstrated evidence of myopathy [85]. The patient’s myalgias and muscle weakness resolved upon discontinuation of ofloxacin. It is unknown whether the myopathic findings on EMG were related to the acute rhabdomyolysis or an underlying myopathy. In another case, a 33-year-old man thought to have norfloxacin-induced rhabdomyolysis was found to be susceptible to malignant hyperthermia by in vitro contracture tests [86], which raises the question of a possible link between the 2 conditions. His clinical complaints of myalgia and weakness and laboratory abnormalities resolved 6 months after discontinuing the norfloxacin. The researchers hypothesized that a similar muscle deficit may have accounted for the patient’s susceptibility to malignant hyperthermia and rhabdomyolysis induced by fluoroquinolones. Both malignant hyperthermia and fluoroquinolone-associated muscle disorders are thought to be triggered by a fluorine-containing compound [86]. To further investigate this possible connection, the same French investigators studied muscle function in 3 patients who presented with myalgia, tendinopathy, and arthralgia associated with fluoroquinolone exposure [87]. These results were compared with 3 patients exposed to fluoroquinolones who had no adverse events and 9 subjects with no known muscle disease who had not taken fluoroquinolones. Muscle contraction and metabolism were investigated through the use of histology, in vitro contracture tests, and 31P magnetic resonance spectroscopy (31P MRS). The 3 patients with fluoroquinolone-associated myalgia and weakness displayed similar metabolic abnormalities, whereas the 3 subjects exposed to fluoroquinolones with no adverse effects displayed normal metabolic profiles. These findings led the researchers to conclude that the adverse effects recorded in the 3 patients were related to a pre-existing muscular anomaly revealed by fluoroquinolone treatment. Further support for the hypothesis that fluorine may be the trigger for fluoroquinolone associated myopathy comes from the fact that no adverse muscular events have been reported with unfluorinated quinolones. In addition, steroid myopathy is thought to occur more frequently with fluorinated steroids (ie, dexamethasone and triamcinolone) than with nonfluorinated steroids (ie, prednisone or hydrocortisone) [88-90]. The researchers recommended that any patient experiencing myalgias associated with fluoroquinolone exposure should undergo noninvasive muscle metabolic testing with 31P MRS along with a subsequent muscle biopsy for histoenzymology and contracture tests if a metabolic disorder is found.

Muscle: Clinical Manifestations

A variety of muscle syndromes have been reported in association with fluoroquinolone use, ranging from mild myalgias to life-threatening rhabdomyolysis[78,85-87,91-95]. In fact, some investigators have proposed that myalgias may be the most common adverse effect of fluoroquinolone use [78]. Symptoms, which typically consist of diffuse muscle pain with or without weakness [86,87,91] and perhaps a predilection for proximal muscle groups [85,92], appear to manifest within 1 week after initiation of fluoroquinolone treatment [94] and often resolve within 1-4 weeks after discontinuation of the medication [78,86,91,92], although symptoms that persisted up to 6 months have been reported [86]. Statins may potentiate fluoroquinolone-associated myopathy (emphasis added) [91,92]. Furthermore, an association may exist between an underlying myopathic process and the development of myalgias and/or rhabdomyolysis after fluoroquinolone exposure, as previously discussed.

It is interesting that the authors of “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population” attribute myalgia and rhabdomyolysis to the fluorine atom that is added to quinolones to form fluoroquinolones. The toxicity of fluorine is often overlooked by researchers and “floxies” alike, in part because of the politics associated with assertions that fluorine and fluoride are toxic (they are). As the first sentence in the quote (“Although the etiology of fluoroquinolone-associated muscle disorders has yet to be fully elucidated”) notes though, the exact mechanism through which fluoroquinolones, statins, and fluoroquinolones and statins together, cause adverse reactions is not fully known.

What is known is that fluoroquinolones, and fluoroquinolones combined with statins, can cause rhabdomyolysis, and that rhabdomyolysis can be deadly.

If you are a “floxie” that is on statins, I highly recommend that you talk to your doctor about the case reports linked above and the possibility of rhabdomyolysis and other myalgias being induced by fluoroquinolones, statins, or both.

If you have existing myalgias, including fibromyalgia, I suggest that you take the quote above to your doctor and get off of all fluorinated drugs–as they have been shown to exacerbate myalgias.

I hope that the millions of people on statins, and their doctors, recognize that fluoroquinolones should not be given to people on statins because the two drugs combined can increase the likelihood of rhabdomyolysis and other myalgias.

I’m sorry that Mr. Howard was hurt by ciprofloxacin and generic Lipitor, but hopefully the publicity that his story is getting will serve as a warning for others.

 

Do Fluoroquinolones Cause Cerebrospinal Fluid Leaks?

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

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

Hypothesis:

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

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

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

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

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

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

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

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

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

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

Citations:

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

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

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

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

 

Study Shows that Quinolone Ear Drops Increase Rates of Eardrum Perforation in Children

A recent study published in Clinical Infectious Diseases, “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” found that children who were prescribed quinolone (fluoroquinolone) ear drops were significantly more likely to experience perforated eardrums than those who used an alternative, non-fluoroquinolone, antibiotic ear drop – neomycin.

In the study, researchers tracked Medicaid data for almost 100,000 children who underwent ear tube surgery (tympanostomy). The researchers then compared post-operative eardrum perforation rates after kids were given either quinolone or neomycin antibiotic ear drops.

The researchers found that children who received quinolone ear drops were 60% more likely to suffer eardrum perforations than those who received neomycin ear drops, and the rates of eardrum perforation were even higher in the children who were given quinolones together with steroids.

One of the study’s authors, Almut Winterstein, noted, “Evidence on quinolones’ detrimental effects on soft tissues, animal studies, clinical trials and observational studies overwhelmingly point to the possibility that quinolones could contribute to the development of persistent eardrum perforations.”

Comments from Victims

When a story about this study was posted on The Fluoroquinolone Wall of Pain Facebook page, several people noted that their children had suffered adverse effects of fluoroquinolone ear drops. The comments included:

“My 14 year old was prescribed Cipro drops multiple times when he was younger for ear infections and after tubes were put in twice. Last month he had surgery to repair a hole in his eardrum. Now I know better…10 years ago I didn’t know.”

“Our daughter was prescribed these for years–always had a bottle on hand to start if we suspected an infection (as per her doctor) Now at 17 she’s had two progressively invasive surgeries to repair an ear tube hole that keeps popping open. She also has hearing loss due to surgeries. Next up is a specialist and a more invasive graft to get it to close. Definitely going to follow up on this research and results……”

“My daughter had two sets of tubes with these drops prescribed both times. At 6, the doctors determined she needed a 3rd set but would not give them to her due to severe perforations of her ear. They dismissed the perforations as caused by ear drum ruptures from ear infections. Now they are telling me that she may always have pressure related problems and may never be able to scuba dive. I refused the drops for her after I was floxed in 2015 by taking Cipro.”

It is absolutely heartbreaking to hear of children being hurt by fluoroquinolones. My heart aches for the parents of these children as well. They are victims of these drugs too.

Quinolones/Fluoroquinolones Damage Connective Tissues

I’m really glad that this study was done, and I commend Doctors Alrwisan, Antonelli, and Winterstein for conducting it. I hope that pediatric ENTs will hear about this study and understand that quinolone/fluoroquinolone ear drops are dangerous, and that they can lead to perforated ear drums and other health complications.

I understand that the alternative to quinolone/fluoroquinolone ear drops, neomycin, has adverse effects as well, but it does not damage connective tissues or lead to eardrum perforation at near the rate that quinolone/fluoroquinolone ear drops do. Quinolone/fluoroquinolone ear drops are dangerous, and they’re not only dangerous to ears. As Bill’s Story on www.fqwallofpain.com notes, other connective tissue problems can occur after using quinolone/fluoroquinolone ear drops. Bill states:

“I went to see my doctor and was prescribed ciproxin eardrops for an ear infection.They didn,t seem to help my ear so went back to doctors and told him my shoulders were very sore and I had a strange rash on my back.He suggested I may have tendonitis.”

Another “floxie” friend stated that:

“Ofloxacin Eardrops have ruined my life. It has left me disabled in horrible pain totally bedridden.”

Fluoroquinolones, in any form, are dangerous drugs that adversely affect all bodily systems–from tendons, to nerves, to hormones, to the gut biome, and more.

Fluoroquinolones should never be used unless a person is facing a life-or-death need, AND there are no safer alternatives. For all the children in the study who were given quinolone ear drops after ear tube surgery (tympanostomy), there was an alternative. Though the alternative, neomycin, is imperfect, it is safer than quinolone/fluoroquinolone ear drops.

Delayed Effects

Fluoroquinolone adverse effects are often delayed for weeks, or even months, after administration of the drug has stopped. This makes recognition of fluoroquinolone adverse effects difficult, to say the least. Retrospective cohort studies, such as, “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” are a good way to identify delayed adverse effects of fluoroquinolones. The researchers who conducted “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” looked at years of medical data (from 1999 to 2006) to determine that the rates of eardrum perforation were higher among those who were prescribed quinolone/fluoroquinolone antibiotic ear drops than those who were prescribed neomycin antibiotic ear drops. The eardrum perforations didn’t happen immediately upon administration of the quinolone/fluoroquinolone ear drops, rather, they were a delayed effect that was only uncovered by looking through medical records.

Fluoroquinolone toxicity resembles many recognized illnesses, including all autoimmune diseases, many neurodegenerative diseases, fibromyalgia, ME/CFS, psychiatric illnesses, digestive problems, autonomic nervous system disorders, diabetes, and more. It would be fascinating, informative, and useful if studies were conducted that looked at medical records of people who had been prescribed antibiotics, then compared future health outcomes to see if those who were prescribed fluoroquinolone antibiotics were more likely to be diagnosed with autoimmune diseases, fibromyalgia, ME/CFS, psychiatric illnesses, digestive problems, autonomic nervous system disorders, diabetes, etc. than those prescribed non-fluoroquinolone antibiotics. I would certainly bet on a strong correlation between fluoroquinolone use and many illnesses, but my bets mean nothing until the studies get done. I am hopeful that more studies examining the long-term effects of fluoroquinolones on multiple areas of health get done. It is only with research, data, and science, that the harm that these drugs do will be adequately recognized.

 

Study citation:

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

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.

Floxie Hope Podcast Episode 21 – James

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

Check it out:

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

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

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

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

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

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

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

 

A Fluoroquinolone Toxicity Post Goes Viral

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

Check it out!

This antibiotic will ruin you.

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

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

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

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

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

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

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

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

 

 

EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics

I hope I’m not too late in posting this. The following notice was published by the European Medicines Agency (EMA) in February, 2017 (and I’m posting it in March). I want to encourage all of my European “floxie” friends to contact the EMA to report your reaction, and to inquire about testifying. Even if testifying isn’t a possibility, we should all pay attention to what the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decides.

The contact person listed on the EMA notice is:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu

HOWEVER, the EMA has given us the contact information for the UK representatives of PRAC (the EMA’s Pharmacovigilance Risk Assessment Committee). Please contact them instead. They are:

julie.williams@mhra.gsi.gov.uk
and
patrick.batty@mhra.gsi.gov.uk

European floxie friends, please reach out to Ms. Benstetter to share your story, or to find out who you should share your story with. The patient testimony at the FDA hearing was moving, powerful, and I believe that it made a difference. Hopefully patient testimony will be allowed by the EMA, and it will make a difference too.

Here is the EMA announcement:

EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics: Review to focus on long-lasting effects mainly affecting musculoskeletal and nervous systems

The European Medicines Agency (EMA) is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects are of particular importance when the medicines are used for less severe infections.

The review is at the request of the German medicines authority (BfArM) following reports of longlasting side effects in the national safety database and the published literature. There has been no previous EU-wide review specifically focusing on the persistence of the side effects, but the side effects themselves are known and covered in the EU prescribing information for these medicines.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there is a need to introduce new measures to minimise these risks or modify how the medicines are used.

Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections. Healthcare professionals using these medicines should continue to follow the official prescribing information.

Patients who have any questions about their treatment should speak to their doctor.

More about the medicines

Quinolones and fluoroquinolones are a class of broad spectrum antibiotics that are active against so-called Gram-negative and Gram-positive bacteria.

The review covers the following medicines: cinoxacin, ciprofloxacin, enoxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.

More about the procedure

The review of quinolone and fluoroquinolone antibiotics was initiated on 9 February 2017 at the request of German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.

The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will issue recommendations. The PRAC recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.

I hope that the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decides to acknowledge the serious adverse reactions caused by fluoroquinolones, and that they restrict the use of fluoroquinolones in Europe.

European friends, if you hear of anything that you can do to push the EMA’s PRAC to to decide to restrict fluoroquinolone use in Europe, please let me know. I’ll update this post if I hear anything new. Thank you!