Tag Archives: fluoroquinolone side effects

Floxie Hope Podcast Episode 18 – Clara

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

Please check it out!

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

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

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

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

After taking Cipro, Clara’s toxicity symptoms included:

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

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

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

 

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Tell Your Fluoroquinolone Toxicity Story

I encourage every person who has been hurt by fluoroquinolone antibiotics (or any other pharmaceutical) to tell his or her story.

Telling your story of pain caused by fluoroquinolones can be cathartic and relieving. In writing your story, you are saying to yourself and others, “My pain is real. I was hurt by a prescription drug. It happened to me. Listen, because this is important.”

These stories ARE important! Patient stories are important for advocacy, for warning others, for changing minds, and more. The world will be a better, safer, place if physicians and patients alike are aware of the adverse effects of fluoroquinolones and all other drugs. Patient stories help people to understand the severity of adverse drug reactions, so that they understand the real risk associated with each prescription drug. Neither our doctors nor our friends are psychic, and they need to be told about adverse drug reactions in order to understand them. True stories about the effects of fluoroquinolones on individual lives vividly illustrate the risks of these drugs—much more than studies, or data, or warning labels.

Patient stories can also help researchers to understand the real-world effects of pharmaceuticals, and the direction that a researcher chooses to look can be influenced by patient reports and stories.

Because patients reported their symptoms to the FDA, the warning labels for fluoroquinolones have changed to note that peripheral neuropathy is a potentially permanent side-effect of fluoroquinolones. Patient reports and advocacy also led to the November 5, 2015 FDA meeting where the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee decided that the current warnings on fluoroquinolone labels are not sufficient. We still have a long way to go, but it should be acknowledged that patients, and their stories, are driving the FDA to action, and that is quite special and unusual.

Reporting Fluoroquinolone Toxicity to the FDA

Please, even if you don’t tell your story to anyone else, report your adverse reaction to the FDA. Instructions on how to report your reaction to the FDA can be found here – http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm.

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Telling Your Story of Fluoroquinolone Toxicity on the Internet

If you would like to tell your story on a web site, there are a few options:

The Fluoroquinolone Effects Study

Please, please, please also tell your story to the researchers who are conducting the Fluoroquinolone Effects Study. The Fluoroquinolone Effects Study is being led by Dr. Beatrice Golomb and it is through UCSD. The Fluoroquinolone Effects Study is a chance to tell your story in your own words to scientists who are studying fluoroquinolone toxicity. More information about the study can be found here – http://www.fqstudy.info/Fluoroquinolone_Effects_Study/Welcome.html.

Media Coverage of Fluoroquinolone Toxicity

Hundreds of people have spoken out to the media about fluoroquinolone toxicity. Thank you to each of you who told your story! I encourage all of you to reach out to the media, because even though many of our stories have been told, many more are needed. Write letters and emails, call your newspaper editors and tv reporters. Please do whatever you can to amplify your voice when telling your story.

People are Listening

People are listening to our screams and our stories. I regularly hear from people who say something along the lines of, “I requested a safer antibiotic because I heard from you that Levaquin is dangerous.” I hear from doctors, nurses, pharmacists, and other medical professionals who are getting information about fluoroquinolone toxicity from Floxie Hope. The number of people in The Fluoroquinolone Toxicity Group on Facebook has increased steadily to almost 5,000 people. Many of those people share information about fluoroquinolone toxicity with their friends. The word is getting out, and that’s a very good thing!

Thank you to all of you who are telling your stories of pain caused by fluoroquinolones! These stories are important, and I even think that it’s healing for you to tell your story.

 

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In Memory of Dr. David Flockhart

On November 26, 2015, the floxie community lost Dr. David Flockhart, M.D., Ph.D., a beloved physician and researcher who passed away at his home in Indianapolis, surrounded by his family, after a year-long struggle with an aggressive form of brain cancer called glioblastoma multiforme.

Dr. Flockhart was a beacon of hope for many people dealing with fluoroquinolone toxicity. He acknowledged the harm done by fluoroquinolones, and was able to help hundreds of floxies with both his vast knowledge of the harm that fluoroquinolones do, and personalized treatment protocols. His floxed patients loved him for his caring bedside manner and he was considered by many to not only be a physician, but also a friend. He will be missed by many.

A lovely obituary for Dr. Flockhart can be found here – http://sideeffectspublicmedia.org/post/remembering-david-flockhart-md

From the above obituary, it is noted that, “Over the course of his career, he (Dr. Flockhart) became one of the world’s foremost authorities on drug interactions and reactions. Patients from around the nation sought his opinion when other doctors insisted they were simply imagining or inventing sometimes painful and debilitating side effects.”

Dr. Flockhart spoke out to the media about adverse effects of fluoroquinolones. He noted in the PBS Newshour Frontline expose, “Certain Antibiotics Spur Widening Reports of Severe Side Effects” that, “You don’t use these big guns, if you like, for killing mosquitoes, for little limb infections. You should use them appropriately for big infections that they’re useful for.”

Also, reported in the Washington Post article, “It Pays to Read the Warnings When You Open Up a Prescription,” “’The vast majority of physicians don’t even know how to report side effects to the FDA. They don’t have a clue,’ says David Flockhart, head of the Department of Clinical Pharmacology at the Medical School of Indiana University. ‘And there’s a psychological resistance to believing that what they’ve done has hurt.'”

Dozens of other quotes from Dr. Flockhart about fluoroquinolones can be found throughout the internet.

Dr. Flockhart didn’t only focus on fluoroquinolone toxicity. His career in research and medicine had many facets. He was a pioneer and leader in the field of pharmacogenetics, the understanding of how an individual’s genes affect his or her response to drugs. Additionally, “He published more than 250 articles, reviews, and book chapters, and was a member of many prestigious professional organizations. He received numerous awards, including the Leon I. Golberg Memorial Lecture Series Award from the University of Chicago, the Rawls-Palmer Award for Progress in Medicine from the American Society for Clinical Pharmacology and Therapeutics, and the Nathaniel T. Kwit Memorial Distinguished Service Award from the American College of Clinical Pharmacology.” (quoted from his obituary)

Candy Markman, a past board member of Amnesty International’s U.S. section and a personal friend of Dr. Flockhart noted that, “He was an enormously compassionate human being who really respected other human beings.”

My condolences to Dr. Flockhart’s family, friends, patients and associates. He is missed.

 

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The FDA Notes that Fluoroquinolones are no Better than Placebos

For the FDA’s November 5, 2015 meeting to review “The Benefits and Risks of Systemic Fluoroquinolone Antibacterial Drugs for the Treatment of Acute Bacterial Sinusitis (ABS), Acute Bacterial Exacerbation of Chronic Bronchitis in Patients Who Have Chronic Obstructive Pulmonary Disease (ABECB-COPD), and Uncomplicated Urinary Tract Infections (uUTI)” a 617 page report was released by the FDA. You can access it HERE if you want to read it in its entirety.

In the next several posts, I will summarize and comment on the report. The following is post 1 of the summary/commentary:

The report starts by noting that fluoroquinolones have never been shown to be safe or effective treatments for sinusitis, bronchitis for those with COPD, or uncomplicated urinary tract infections. No placebo-controlled trials were conducted when approving fluoroquinolones as treatments for these diseases. Per the FDA:

“Antibacterial drugs approved before the 1980s were in general used as the control antibacterial drugs in NI trials. Because placebo-controlled trials were not used as a basis for the approval of those drugs, a treatment effect of the control antibacterial drugs over placebo had not been clearly established for ABS, ABECB-COPD, or uUTI. Thus, these active-controlled studies may not provide a reliable means to evaluate efficacy of antibacterial drugs for these indications.”

No placebo-controlled studies were used for approval of fluoroquinolones (or any other antibacterial drugs, apparently) in the treatment of sinus infections, bronchitis for those with COPD, or uncomplicated urinary tract infections. It’s just now occurring to the FDA that without placebo-controlled trials, they may not have reliable evidence of the efficacy of these drugs. Ya think?

The report goes on to note that the Cochrane Collaboration concluded the following about treatment of sinusitis with antibiotics:

“The Cochrane Collaboration conducted a review of antibacterial drugs for treatment of clinically diagnosed acute rhinosinusitis in adults and provided this statement in their conclusion: ‘Taking into account antibiotic resistance and the very low incidence of serious complications, we conclude that there is no place for antibiotics for the patient with clinically diagnosed, uncomplicated acute rhinosinusitis’ (Lemiengre, van Driel, et al, 2012).”

Additionally, regarding bronchitis in those with COPD, the FDA report notes that, “Clinical practice guidelines for treatment of ABECB-COPD published by the American College of Physicians stated, ‘Among patients with mild attacks, there were no significant differences between those who received antibiotics and those who received placebo.’”

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The case regarding uncomplicated urinary tract infections is a bit more convoluted, but the report does note that, “In a study (of patients with uncomplicated urinary tract infections) that used ibuprofen as a control, there was no treatment difference on symptom resolution in comparison to an antibacterial drug.”

We rely on the FDA to evaluate drugs to make sure that they are safe and effective. Fluoroquinolones are far from safe—they lead to multiple musculo-skeletal and nervous system adverse effects (most of which are described in the 43 page warning label for Cipro/ciprofloxacin). I was assuming that they were at least effective. It turns out that fluoroquinolones are no more effective than a placebo at treatment of sinus infections, bronchitis or uncomplicated urinary tract infections. (They’re no more effective than a placebo at treating prostatitis either – see THIS POST.) People are getting poisoned and severely hurt by fluoroquinolones–for no good reason. Fluoroquinolones are no more effective than a placebo at treating many of the conditions they are prescribed for, and people would be far better off taking a sugar-pill than they are taking a topoisomerase interrupting chemo drug that is no more effective than a placebo.

The FDA approved fluoroquinolones for use in treatment of sinus infections, bronchitis for those with COPD, and uncomplicated urinary tract infections based on the assumption that they were safe and effective, not on actual studies showing that assumption to be true. They are not safe, and they are no better than a placebo for treatment of these conditions. For more than 30 years, the FDA has been using false assumptions and faith, rather than evidence established by placebo-controlled trials, as the basis for approving dangerous drugs for treatment of benign infections that the body can fight off using its immune system (or a placebo).

The mantra of “all drugs have side-effects” is often spewed by people who think that side-effects are acceptable. But with any veil of acceptability comes the assumption that dangerous drugs are at least effective. Fluoroquinolones aren’t even effective at treating sinusitis, bronchitis or uncomplicated UTIs—diseases that they are prescribed for thousands of times every day. They are no better than a placebo at treating those conditions. They are neither safe nor effective and people would be better off taking snake oil than they are taking ineffective drugs that deplete mitochondrial DNA and lead to tendon ruptures, permanent peripheral neuropathy, serious central nervous system adverse effects, and more.

Fluoroquinolones are neither safe nor effective. Every person who has been hurt by a fluoroquinolone taken to treat sinusitis, bronchitis or an uncomplicated UTI was hurt because of the FDA’s ineptitude and their inability to realize that antibiotics need to go through placebo-controlled trials just like every other drug.

This situation, where the FDA approves unsafe and ineffective snake-oils to be sold by the pharmaceutical juggernauts as long as they are labeled as “antibiotics,” is only going to get worse with the passage of the 21st Century Cures Act. The 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. In an op/ed article in the New England Journal of Medicine, it is noted that:

“The proposed legislation would make immediate changes with respect to new antibiotics and antifungals by enabling their approval without conventional clinical trials, if needed to treat a ‘serious or life-threatening infection’ in patients with an ‘unmet medical need.’ In place of proof that the antimicrobial actually decreases morbidity or mortality, the FDA would be empowered to accept nontraditional efficacy measures drawn from small studies as well as ‘preclinical, pharmacologic, or pathophysiologic evidence; nonclinical susceptibility and pharmacokinetic data, data from phase 2 clinical trials; and such other confirmatory evidence as the secretary [of health and human services] determines appropriate to approve the drug.’ Antimicrobials approved in this manner would carry disclaimers on their labeling, but there is no evidence that such a precaution would restrict prescribing to only the most appropriate patients. If passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use. The bill gives the secretary of health and human services the authority to expand this nontraditional approval pathway to other drug categories as well, if “the public health would benefit from expansion.”

Don’t think for a second that the FDA is keeping snake-oils off the market. They’ve been allowing drugs that are more dangerous than snake-oils, and no more effective, to be sold to the American public for years.

I hope that they at least try to undo some of the damage done in the November 5th meeting. We shall see.

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Unintended Consequences of Pharmaceuticals (Especially Fluoroquinolones)

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Before I started studying adverse drug reactions / biochem / cellular biology, I thought that there were people who had a pretty good grasp of how everything within the human body works. I was wrong about that – I was ignorant. It took a lot of research for me to realize that the body is so incredibly (beautifully) complex, and that systems are so unpredictably intertwined, that no one really grasps how it all works. We aren’t even close. But pharmaceuticals throw a wrench in many biochemical pathways whether we are aware of them or not. Ignorance is not bliss. The complexity of life is mind-bogglingly amazing. How ’bout we stop messing with it in ways that hurt us?

A post about how complex and interconnected all of our biological systems are, and about how messing up any or all systems with pharmaceuticals is probably not the best idea, can be found here –

SIDE EFFECTS AND UNINTENDED CONSEQUENCES OF POPULAR PHARMACEUTICALS

Many of the thoughts behind the post are based on THIS CHART.

There is nothing simple about biochemistry, but there is something that is beautiful and incredible about it.  All of those systems work together, and amazingly, they work together perfectly most of the time.  I find it to be mind-blowing and I’m a bit awe struck by what incredibly complex creatures we are.

Pharmaceuticals have the power to disrupt our biochemical systems.  I wish that we were using a bit more prudence with powerful concoctions that can hurt us in multiple ways.

 

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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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Antibiotics After Fluoroquinolone Toxicity

People often ask about what they should do to treat infections post-flox.  Here are my tips.

First, please INSIST on getting your infection cultured and confirmed before you take any antibiotics.  As anyone who has had an adverse reaction to an antibiotic can tell you, antibiotics are not benign drugs.  They have side-effects (HERE is the 43 PAGE warning label for Cipro/Ciprofloxacin).  Some of those side-effects are life-altering and/or life-threatening.  You don’t want to put any drugs into your body unless you absolutely need them.  A culture should be done to confirm that an infection is present before you take an antibiotic – no matter what.

Because antibiotics have been shown to wreak havoc on the microbiome and bactericidal antibiotics damage mitochondria – and because both microbiome disruptions and mitochondrial dysfunctions are linked with every chronic disease there is – I highly recommend looking into some non-pharmaceutical options first.  Garlic has been shown to have antibiotic qualities and to be more effective against biofilms than many antibiotics.  For urinary tract infections, D-mannose has effectively helped thousands of people get rid of their infection.  Some other non-pharmaceutical remedies for urinary tract infections can be found HERECoconut oil has been shown to have anti-bacterial qualities and it may be good for treating skin and GI infections.  Colloidal silver not only has anti-bacterial qualities on its own, it also has been shown to increase the effectiveness of pharmaceutical antibiotics when used in conjunction with them.  Andrographis is an herb that has antibiotic qualities.

If non-pharmaceutical options aren’t working and you need an antibiotic to get rid of your confirmed infection, here are the antibiotics that I recommend along with reasons as to why I recommend them (or not).

  1. Most Floxies seem to do well with doxycycline and other tetracyclines. Tetracyclines are bacteriostatic antibiotics that, “stops bacteria from multiplying but does not kill them.” (source)
  2. Several Floxies have taken Z-pack’s without incident
  3. Amoxicillin seems to be about as benign as antibiotics get. So, it’s not harmless, but it’s well tolerated generally.
  4. Penicillin seems to be well tolerated – unless you’re allergic to it.
  5. Cephalosporins seem to be well tolerated

There are probably some other antibiotics that are fine for Floxies, I just haven’t heard about them.  Please feel free to leave a comment below if there is an effective and relatively safe one that I’m missing.

Here are the antibiotics that I recommend avoiding because they have side-effects that are similar to those of fluoroquinolones, and because many Floxies react badly to them –

  1. Macrobid / Nitrofurantoin
  2. Flagyl / Metronidazole
  3. Bactrim / Trimethoprim / Sulfamethoxazole
  4. Augmentin

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Fluoroquinolones – Cipro/Ciprofloxacin, Levaquin/Levofloxacin, Avelox/Moxifloxacin, Floxin/Ofloxacin and a few others – should be avoided entirely unless you are dying and make the decision that getting “floxed” is preferred to death.  Every warning label for every fluoroquinolone says that people who have an existing hypersensitivity to a fluoroquinolone should not take them again.  “Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.” (Warning Label)

Before you take an antibiotic, or any pharmaceutical for that matter, I highly recommend that you look up the review for that drug on http://www.askapatient.com/ and look it up on http://www.peoplespharmacy.com/.  Also, look up the drug’s warning label.  Be informed.  Make an informed decision.

Here is a list of antibiotics – http://en.wikipedia.org/wiki/List_of_antibiotics  I didn’t get close to going through all of them.  But I hope that this post gives you some guidance when/if you are faced with an infection.

I’m not a doctor, so please take this advice for what it’s worth.  Doctors should be consulted when you have an infection.  The internet should be consulted too though, because doctors aren’t capable of knowing everything and informed consent is really important.

 

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