Tag Archives: Floxin

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.

 

 

Children are Being Hurt By Fluoroquinolone Antibiotics

It breaks my heart when I hear about children getting “floxed.” It’s bad enough that fluoroquinolones inflict pain, tendon tears and ruptures, dysglycemia, insomnia, psychiatric problems, autonomic nervous system disturbances, hormonal issues, and more, on adults–it’s horrifying when those things happen to children. Our children, our babies, our innocent and precious kids, are getting hurt by fluoroquinolones too. We try to protect our children–it’s our job to protect them. We trust that when we go to the pediatrician, he or she won’t poison our babies, but, tragically, sometimes pediatricians do, indeed, poison children with fluoroquinolones. Sometimes they prescribe Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin to children, and sometimes those children suffer devastating consequences from taking those drugs.

It is so incredibly wrong to give children drugs that can cause permanent pain and disability that I’m furious that it happens at all. I’m also furious that there aren’t any consequences for the various parties that allow fluoroquinolones to be prescribed to children. In case it needs to be said, hurting children, and chemically causing pain and disability for young boys and girls, is wrong.

It is well-documented that fluoroquinolones cause permanent lameness in juvenile animals and that they are contraindicated for the pediatric population. A review in U.S. Pharmacist notes that:

“Fluoroquinolones have demonstrated adverse effects on cartilage development in juvenile animals through the inflammation and destruction of weight-bearing joints.  These arthropathies were often irreversible, and their potential occurrence in children limited the use of fluoroquinolones in this population.  In one pediatric study, ciprofloxacin had a 3.3% (9.3% vs. 6.0%) absolute risk increase in musculoskeletal events within 6 weeks of treatment compared with control agents used to treat complicated UTIs or pyelonephritis. Adefurin and colleagues found a 57% increased relative risk of arthropathy in children given ciprofloxacin (21% overall) versus those in a non-fluoroquinolone comparator arm. In contrast to animal models, neither dose nor duration had an effect on the rate or severity of arthropathy.  A 2007 study by Noel and colleagues determined the incidence of musculoskeletal events (primarily arthralgias) to be greater in children treated with levofloxacin compared with nonfluoroquinolone-treated children at 2 months (2.1% vs. 0.9%; P = .04) and 12 months (3.4% vs. 1.8%; P = .03).  These results and the severity of the effects should be weighed heavily when initiation of fluoroquinolones is being contemplated in pediatric patients.”

To summarize, fluoroquinolones can cause irreversible musculoskeletal harm and in doing so, they can put an end to a child’s days of running, jumping, playing soccer, skiing, dancing, etc. Think about that for a second–a drug, an antibiotic no less, can cause permanent damage to the musculoskeletal system of a child. Fluoroquinolones also have serious CNS effects, and can cause psychiatric disturbances as well as loss of memory and concentration. Children, with their developing bodies and minds, should not be subjected to dangerous, disabling drugs that can set back their development and their lives.

Given the documented adverse effects of fluoroquinolones on children, and the black box warning that notes that they can cause disability, the following examples of children being hurt by fluoroquinolones are both infuriating and heartbreaking. Still, I think they should be shared, so as to warn other parents of the dangers of these drugs, and hopefully fewer children will get floxed in the future.

I have paraphrased the stories that I’ve heard, but all of these are true:

  1. A 16 year old boy has Cipro 17 times over the last 7 years. He has various health issues, including a problem with the bones in his feet. The pain in his feet is so bad that he has had to stop school and homeschool on the computer.
  2. A 9 year old took fluoroquinolone ear drops twice as a toddler and suffers with chronic foot and knee pain.
  3. A young woman was floxed 4 1/2 years ago at 16 years old. After about 2 years, she got better, eventually reaching about 90-95% better, only to have a relapse for no apparent reason about a year later (which is where we are now)! She has had MANY devastating side effects, and still cannot work. When she got her first job is when the relapse took place.
  4. A 15 year old girl passed away 6 days after her 10 day Levaquin script.
  5. An 8 year old girl had to quit all sports swimming and gymnastics. She is now going to school but no P.E., and no Dr. Wants to take responsibility for how to help with her pain. It’s been only 2 weeks since taking 3 days worth and then being hospitalized because of the effects.
  6. A 10 year old girl who cannot stand or walk, and no doctors believe her. 
  7. A 16 year old girl took 2 pills of 500 mg of cipro and now has nerve twitching, leg pain, anxiety, and a whole bunch of other symptoms. 

These are kids! They are children and adolescents who are being hurt by fluoroquinolones. They are suffering and there is nothing that doctors can do to relieve their pain. It’s beyond heartbreaking–it’s infuriating–and it needs to stop. The FDA needs to put enforceable restrictions on pediatric fluoroquinolone use. The doctors who prescribe fluoroquinolones to children need to be held accountable when they hurt children with fluoroquinolones (either through Medical Board punishment, or lawsuits). The pharmaceutical companies that make these dangerous drugs need to be punished and they need to compensate their victims. Researchers need to be looking into a cure for fluoroquinolone toxicity. All parties involved need to help these kids to recover, because there really isn’t anything okay about hurting a child.

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Updated Black-box Warnings for Fluoroquinolones

In July, 2016, the FDA made significant changes to the warning labels for all fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, Noroxin/norfloxacin, and Factive/gemifloxacin). These label changes include black-box warnings for fluoroquinolones that state:

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including CIPRO®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture 
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions, reserve CIPRO for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

You can view all of the updated fluoroquinolone labels HERE.

These updated black-box warning labels are HUGE steps in the right direction. The FDA is acknowledging, in a highlighted black-box section of the warning labels, that fluoroquinolone adverse-effects can be serious, irreversible, and disabling. They’re also acknowledging peripheral neuropathy and central nervous system effects, in addition to the adverse-effects on tendons, in the black-box warning. Additionally, the black-box warning states explicitly that fluoroquinolones should not be used for treatment of patients with chronic bronchitis, uncomplicated cystitis (I wish they would have said “urinary tract infections” instead of “cystitis” as they did in the hearings and preliminary documentation), and sinusitis, unless there are no alternative treatment options.

If this updated black-box warning had been in place when fluoroquinolones were first introduced to the market (in the 1980s and 1990s), many people would have been saved from being “floxed.” If these warnings had been in place when fluoroquinolones entered the market, or even when people started screaming about the significant damages and injuries caused by fluoroquinolones, perhaps more doctors would be aware of the dangers of these drugs, and they would be used more appropriately (only in life-or-death situations where there are no alternatives available). Currently, unfortunately, most people are not aware of the devastating effects of fluoroquinolones. Hopefully this updated black-box warning label will enlighten both patients and physicians about the serious and severe dangers of fluoroquinolones.

Prior to this update, the black-box warning for Cipro (and other fluoroquinolones) stated:

Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS).

Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis (see WARNINGS).

This 2008 black-box warning was hard fought for, as both Bayer and Ortho-McNeil-Janssen (a subsidiary of Johnson & Johnson) wanted to bury the risks of tendon ruptures in small-text embedded in the warning labels, rather than highlighting the increased risk in a black-box warning. It was only after Public Citizen sued the FDA that this black-box warning was added to fluoroquinolone warning labels.

Though the old black-box warning was a significant victory at the time, it left much to be desired. The statement that, “This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants,” suggests that those who are under 60 years of age, not taking corticosteroid drugs, and who have not had kidney, heart, or lung transplants, can safely take fluoroquinolones. Though it is also noted that the risk of tendon ruptures is increased for people of “all ages,” it is common to hear of people being told that they wouldn’t have problems with fluoroquinolones because only older people, or people with myasthenia gravis, are at risk for experiencing adverse-effects. This simply isn’t true, as there are thousands of people who have been hurt by fluoroquinolones who are under the age of 60, do not have myasthenia gravis, who are not on corticosteroid drugs, and who have not had an organ transplant.

The old black-box warning gave people (both patients and physicians alike) the impression that fluoroquinolones are only unsafe for certain, small sections of the population. The truth is, fluoroquinolones can cause devastating, severe, disabling adverse-reactions in people who are young and old, strong and weak, fit and out-of-shape, and, at this time, there is no way to determine who will have an adverse-reaction and who won’t. There are almost certainly factors that predispose some people toward having devastating adverse-reactions to fluoroquinolones while others seem to be able to take fluoroquinolones without problem, but we don’t know what those predispositions are. No one knows if people who have latent autoimmune or endocrine system disorders, or who have MTHFR genetic mutations, or who are G6PD deficient, or who have leaky gut, or who have been exposed to heavy metals, or any other potential risk factor, are more succeptible to fluoroquinolone adverse-reactions than anyone else. There is a dice-roll, a pull of the Russian roulette trigger, every time ANYONE takes a fluoroquinolone because NO ONE knows what the real risk factors are, or even how frequent/rare adverse-reactions are. I wish that it was explicitly said on the fluoroquinolone warning labels, preferably in the black-box warning, that risk-factors are currently unknown and that everyone who takes fluoroquinolones is potentially at risk for experiencing disabling adverse-effects.

I also wish that it was noted in the black-box warning that adverse reactions to fluoroquinolones can be delayed for weeks, months, or even years after administration of the drugs has ceased. And I wish that people were warned that ceasing administration of the drug may not stop the adverse-reaction, and that the symptoms of fluoroquinolone toxicity can continue long after the drug “should” be out of one’s system.

I also wish that the danger of co-administering fluoroquinolones and corticosteroid drugs had stayed in the black-box warning, and I wish that the contraindication of NSAIDs and fluoroquinolones was noted in the black-box warning.

I wish that “cystitis” was changed to “urinary tract infection,” or that they were both mentioned as ailments for which the use of fluoroquinolones is not appropriate unless there is no alternative. I also wish that prostatitis and travelers’ diarrhea were added to the list of ailments for which fluoroquinolones should not be used unless there is no alternative.

Perhaps the next iteration of the black-box warning on fluoroquinolones will note those things. I wish I, and my doctor, had been warned more thoroughly about the dangers of fluoroquinolones before she prescribed them to me, and before I took them. Hopefully the updated black-box warning label will help physicians and patients to realize how dangerous fluoroquinolones are, and will keep many people from getting “floxed.”

Though the updated black-box warnings still leave a bit to be desired, they are a HUGE step in the right direction. Acknowledgement from the FDA that fluoroquinolone adverse-effects can be irreversible and disabling, and that they should not be used to treat many common conditions unless there are no other treatment options available, is very big news, and it should be celebrated. We are making progress, and hopefully fewer people will be hurt by fluoroquinolones because of these black-box warning updates.

 

 

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Prescription for Disaster – 22 years later

Bitter Pills Fluoroquinolone Toxicity Book

In Stephen Fried’s 1994 Washington Post article, Prescription for Disaster, Fried describes his wife Diane’s terrifying reaction to Floxin (ofloxacin), a fluoroquinolone antibiotic. It’s a wonderful, award-winning article on which Fried’s follow-up book, Bitter Pills: Inside the Hazardous World of Legal Drugs, was based. I highly recommend that you read both the article and the book.

This quote from Prescription for Disaster summarizes both well:

“Before Diane’s frightening experience, I had always thought of prescription drugs as pretty much idiot-proof. Your doctor tells you to take them, so you do, assuming that the worst that can happen is they won’t work. It turns out the worst that can happen is that you drop dead. The next worst is that your body is permanently damaged. Less worse, but still not very good, is that you suffer for hours, days or weeks with something your doctor may or may not recognize as a drug reaction — from one drug or an interaction. It may or may not go away by itself.”

Though both Prescription for Disaster and Bitter Pills are about the hazards of prescription drugs generally, both have quite a bit of information about fluoroquinolone toxicity, and Diane’s personal story of a severe CNS adverse reaction to Floxin is discussed in-depth.

In Prescription for Disaster, Fried notes:

“I KEEP WANTING this story to end, but it never does. Late last year I got a call from a producer of Oprah Winfrey’s show. She wanted to do a program on adverse drug reactions because she had just had one — to Floxin. Diane and I appeared on the program, along with several other people we had met through the original article, and since then I’ve gotten a steady stream of calls. Many of them are from people who had almost the same reaction Diane did, but weren’t as lucky to have doctors who at least recognized a drug reaction and were willing to learn what they didn’t know about how to treat it. I’ve talked to people whose spouses have lost their careers in the aftermath of drug reactions, people whose fathers attempted suicide because of depression that seemed to have been triggered by quinolones.”

We all want this story to end. More than 22 years later (Prescription for Disaster was published in April, 1994), it is still going on. Thousands of people are hurt every year by fluoroquinolones. People are experiencing tendon ruptures that leave them in horrible pain, exhaustion that leaves them bed-bound, gastro-intestinal issues that leave them unable to eat, CNS issues that leave them unable to work, peripheral neuropathy that leaves them in permanent pain, and more. I sincerely hope that the story of people becoming chronically ill and disabled after taking Cipro, Levaquin, Avelox, Floxin, or their generic equivalents, ends soon. It’s not a good story, it would be nice if it ended sooner rather than later.

On the WONDERFUL site, http://fluoroquinolonethyroid.com/, the author notes the following about the publication of Prescription for Disaster in 1994:

For anyone who thinks that the FQ ADR’s are something new, think again. It’s an old, old story, this one, which actually goes back much farther than 1994. But this article highlights how Pharma, FDA, flox victims, the ignorant and dismissive medical profession, even publicity on shows like GMA, Dateline, Donahue, and even Oprah — they were all there —  it’s all happened before — way back in 1994. It’s all been completely ignored; and in fact, sales of FQ’s continued to increase and soar exponentially during the past 20 years. I, and who the hell knows how many others just like me, have been “floxed” since then. Had the FDA, Pharma, and the medical profession done their job back then, my life (and many others) might have been spared.

Don’t think Pharma or the FDA is just finding out about these ADR’s now. They’ve known. They’ve known for a very, very, long time. And they’ve done absolutely nothing about it.

So when you hear all the Pharma companies make their same old tired and outright spurious statements over and over again about how “Safety is our greatest concern, and these antibiotics have been prescribed safely for the last 20-30 years without problems,“ and the FDA says “We take these safety issues very seriously and are looking into it,“ you’ll know what bullshit that is. There is a historical record accumulating, and this article is just one example for you to post in rebuttal.    Remember:  the internet saves everything now. There will be less and less places for Pharma to hide as time goes on and the number of victims the world over continue to grow.

FQ’s are once again in the news. We can only hope that this time, it will be different.

Yes, we can hope that this time will be different. We need to stay vigilant though, and continually push, so that the pharmaceutical companies, the FDA, and even many doctors and nurses cannot get away with the lies of, “Fluoroquinolones have an excellent record of safety and efficacy,” and, “Side-effects are rare,” and, “There is no known mechanism for fluoroquinolones to cause multi-symptom, chronic disease,” and, “Multi-symptom, chronic diseases are in patient’s heads – they don’t really exist,” and, “Fluoroquinolones aren’t connected with autoimmune diseases, fibromyalgia, ME/CFS, POTS, arthritis, psychiatric illnesses, thyroid autoimmune diseases, etc.” Those lies have been told over and over again since fluoroquinolones first entered the market in the 1980s. Repetition doesn’t make them true, but it sure helps to reinforce the lie.

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There is plenty of evidence that fluoroquinolones are dangerous, destructive drugs that can lead to chronic illness and disability for many. There is also evidence that the mitochondrial destruction done by fluoroquinolones is similar to that of mitochondrial destruction found in people with autoimmune and other “mysterious” diseases. The evidence isn’t even new. They’ve known since 1994 that these drugs are damaging to the point of being disabling. They know, they just choose not to do anything meaningful about it. It is possible to put meaningful restrictions on dangerous drugs that ensure that they are only used when appropriate (in life-or-death situations) and that proper informed consent is given before the drugs are administered. Rather than making these meaningful changes though, the FDA and the pharmaceutical companies have chosen to largely ignore the problem.

Everyone who has gotten “floxed” since 1994 has been hurt because of willful ignorance on the part of the FDA. They claim, over and over again, that these reactions are new, and that they’re just now hearing about them. I realize that news sinks in slowly in a bureaucratic institution like the FDA, but 22 years is ridiculous and, frankly, unacceptable. They knew that these drugs were dangerous then, because people told them back then. They know that these drugs are dangerous now, because people have told them again. Research has also accumulated since 1994, and there are hundreds, if not thousands, of articles about the dangerous effects of fluoroquinolones published in journals (here’s a sampling of just a few – https://floxiehope.com/fluoroquinolones-links-resources/).

When is this going to stop? When will the FDA start doing it’s job and adequately regulating these dangerous drugs? How many more people have to get hurt by fluoroquinolones? How many more times do we have to scream at them and tell them what they already know – what they have known for more than 22 years – that fluoroquinolone adverse reactions are severe and devastating? It’s ridiculous. This mess should have been stopped 22 years ago. The FDA should have made meaningful changes to prescription guidelines for fluoroquinolones in the 1990s. If not then, they should have done so in 2008 when Public Citizen sued the FDA in order to get the black box warning about tendon ruptures added to the fluoroquinolone warning labels. Since meaningful reform didn’t happen then, how about now? The FDA just had a hearing about the risks of fluoroquinolones, and found that the risks outweigh the benefits in treatment for many common infections. They have the opportunity to enact meaningful change now, and they should do so.

I doubt that they will make meaningful, appropriate changes though. Business will go on as usual. People will continue to be hurt by fluoroquinolones. People who should know better (FDA personnel, Pharma scientists, doctors, etc.) will insist on saying that these adverse-reactions are rare, and thus insignificant and untrue. It’s a shame, because they are incorrect. These adverse reactions are severe, devastating, and not near as rare as they should be.

So… we have to keep screaming. We have to keep telling the news media about our reactions, writing to anyone who might listen, filing reports with the FDA, writing articles and blog posts, petitioning scientists, talking to friends, sharing articles, etc. We have to keep banging the drum until they listen.

I’m not sure how long this process will take. It’s been 22 years since Prescription for Disaster was published. I hope that it doesn’t take 22 more.

 

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Preventing Fluoroquinolone Toxicity

I was talking with my boyfriend about yesterday’s post, “Researching Cures for Fluoroquinolone Toxicity,” and he brought up a good point:

Yes, a cure would be nice, but fluoroquinolone toxicity is just so preventable – prevention seems like a better strategy. 

Yes, we (as a society) could pour tons of money, time, resources, etc. into finding a cure for fluoroquinolone toxicity, OR we could stop floxing people and prevent them from needing said cure in the first place.

As Benjamin Franklin wisely noted, “an ounce of prevention is worth a pound of cure.”

For those of us who have been hurt by Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin, a cure is very much needed and wanted. We know our poison, now where’s our antidote? It’s a reasonable and appropriate question for those who have been hurt, but I believe that prevention of damage will help more people than a cure.

Dear doctors, nurses, pharmacists, and everyone else in the medical system: STOP prescribing fluoroquinolones unless your patient is fighting a verified, life-threatening infection that is not responding to other drugs! 

People are suffering from disabling fluoroquinolone toxicity reactions after taking Cipro when there are other viable treatments and/or when antibiotics aren’t even needed.

People are regularly prescribed Cipro to treat travelers’ diarrhea and some of those people experience debilitating adverse reactions to it. Their reaction and their suffering are avoidable though, because travelers’ diarrhea is treatable with more benign methods – probiotics, hydration, and Pepto Bismol should do the trick. Most cases of fluoroquinolone toxicity due to taking Cipro, Levaquin, Avelox or Floxin for travelers’ diarrhea are completely PREVENTABLE!

Even the FDA has acknowledged that the risks of using fluoroquinolones outweigh the benefits when treating sinus infections, bronchitis, and uncomplicated UTIs:

“FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.” (Source – straight from the FDA.)

Everyone who is suffering from fluoroquinolone toxicity after taking Cipro, Levaquin, Avelox, or Floxin as treatment for a sinus infection, bronchitis, or an uncomplicated urinary tract infection was hurt even though more benign antibiotics (or time, assuming that one’s immune system is functioning properly) could have been used.

Many cases of prostatitis aren’t bacterial, yet many men are given long courses of fluoroquinolone antibiotics to “treat” their prostatitis. In case it needs to be said, fluoroquinolone antibiotics are no better than placebos at treating non-bacterial prostatitis. Too many urologists are prescribing dangerous drugs (fluoroquinolones) that are no better than placebos, and hurting many men in the process.

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Many people are prescribed Cipro, Levaquin, Avelox or Floxin to treat non-bacterial bladder pain. Interstitial Cystitis (IC) is a great imitator of bladder infections, and fluoroquinolones do NOTHING to treat IC pain–they may even make it worse.

All the pain and suffering that comes with fluoroquinolone toxicity, and there’s a lot of it, is SO PREVENTABLE for so many people! Remember: DO NO HARM! 

According to FDA figures, 26.9 MILLION prescriptions for fluoroquinolones were disbursed in 2011 alone (they haven’t updated their figures since 2011). Too many of those prescriptions were inappropriate. Many of them were for ailments that weren’t even bacterial infections.

“‘Antibiotic therapies are used for approximately 56 percent of inpatients in U.S. hospitals, but are found to be inappropriate in nearly half of these cases, and many of these failures are connected with inaccurate diagnoses,’ study author Dr. Greg Filice said in a news release from the Society for Healthcare Epidemiology of America.” (source)

Everyone in the medical system needs to recognize that adverse reactions to fluoroquinolones are disabling, often permanent, and that they look a lot like a multi-symptom, chronic illness. Unfortunately, at this time, there is no way to tell who will have an adverse reaction to a fluoroquinolone, so, as far as doctors should be concerned, EVERYONE is at risk. Fluoroquinolones are dangerous drugs, and their benefits do not outweigh their risks for many infections. They should ONLY be prescribed for treatment of verified, life-threatening infections that cannot be treated with more benign drugs.

If those basic rules were followed, there would be significantly fewer “floxies.”

Prevention is the answer to this problem.

A cure would be nice, but prevention is better.

The FDA acknowledges that fluoroquinolones have potentially permanent adverse effects, and that their risks outweigh their benefits for many patients/conditions. Now the FDA needs to put some policy changes behind this knowledge, and make sure that fluoroquinolones are not prescribed inappropriately.

Enacting policies that cut fluoroquinolone prescriptions by about 90% would be a good place to start.

Yes, there are cases when fluoroquinolones are the appropriate drugs to use – when a patient is facing death without the drugs. But a large portion of the prescriptions being written for Cipro, Levaquin, Avelox, and Floxin are completely inappropriate. A large portion of the pain, suffering, and destruction caused by fluoroquinolones is preventable.

The FDA is capable of enacting policies that prevent many cases of fluoroquinolone toxicity. They have the information, they have the power, they need to do what is right –

Stop unnecessary fluoroquinolone prescriptions! Prevent disabling fluoroquinolone toxicity!

There are safer drugs available in most cases.

 

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An Official Name: Fluoroquinolone-Associated Disability (FQAD)

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 last post, I noted that the FDA report said that fluoroquinolones have not been shown to be any better than a placebo at treating sinus infections, bronchitis in those with COPD, or uncomplicated urinary tract infections. In this post, I will point out that the FDA has given those suffering from fluoroquinolone toxicity an official name. Per the report:

“A review of the FDA Adverse Event Reporting System (FAERS) was performed to characterize a constellation of symptoms leading to disability that had been observed during FDA monitoring of fluoroquinolone safety reports. This constellation of symptoms will be referred to in this review as ‘fluoroquinolone-associated disability’ (FQAD). While most of the individual AEs that exist within FQAD are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not. Individuals with FQAD were defined as U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI). To qualify, individuals had to have AEs reported in two or more of the following body systems: peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular and skin. These body systems were chosen as they had been observed to be frequently involved with the fluoroquinolone reports describing disability. In addition, the AEs had to have been reported to last 30 days or longer after stopping the fluoroquinolone, and had to have a reported outcome of disability.”

That recognition from the FDA is EXCELLENT progress!

I don’t know whether or not FQAD will be put into diagnostic manuals, or if it will be coded for in insurance systems. I hope that those are future steps that will be taken.

So far, in the first 20 pages of the 617 page FDA report, they have noted that fluoroquinolones are no more effective than placebos in treatment of sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. They have also noted that fluoroquinolones can cause a constellation of symptoms across multiple body systems, and that those symptoms can lead to disability.

It is not appropriate to cause, or even to risk, disabling adverse effects through utilization of a drug that is no more effective than a placebo at treating sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. I hope that the FDA changes the recommended uses for fluoroquinolones in recognition of this.

I hope that the naming of FQAD increases recognition of the horrible adverse effects of fluoroquinolones. With recognition, hopefully a more prudent and appropriate approach to use of fluoroquinolones will occur.

Post-publishing edit – While it is a wonderful step in the right direction that the FDA acknowledged that fluoroquinolones can cause a constellation of symptoms that is not adequately noted in the warning label, I may have jumped the gun a bit in calling it an “official” name. FQAD is the term that the FDA is using for the purposes of the November 5th hearing. It is not a diagnostic code that your doctor can look up in his or her diagnostic manuals yet. I hope that it’s a step in that direction, but we’re not there yet. Celebrating the FDA acknowledgement is in order, but we still have a ways to go. I apologize for not being more clear in the post before I originally published it!

 

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The Next Time Will be Worse: Cross-Reactivity of Fluoroquinolones

On every single warning label for each fluoroquinolone it says that if a person has experienced an adverse reaction to a quinolone, they should not be exposed to quinolones again.

The Cipro/ciprofloxacin warning label says:

“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.”

The Avelox/moxifloxacin warning label says:

“Contraindications: Known hypersensitivity to AVELOX or other quinolones.”

The Ciprodex ear drop warning label says:

“CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.”

Yet these warnings are disregarded regularly. I often hear from people who tell their doctor that they are allergic to Levaquin, and their doctor prescribes them Cipro. Or they tell their doctor that they are allergic to Cipro, but are still prescribed ofloxacin eye drops. There seems to be a lack of understanding of the cross-reactivity or one quinolone with all other quinolones.

The lack of knowledge and understanding is not because of lack of documentation. In an article in Current Pharmaceutical Design entitled “An Update on the Diagnosis of Allergic and Non-Allergic Drug Hypersensitivity,” it is noted that, “cross-reactivity among quinolones at both the IgE- and T-cell level is clinically well documented. Therefore, patients with hypersensitivity reactions to any quinolone should not be re-exposed to any antimicrobial agents of that class.”

Additionally, in The European Journal of Allergy and Clinical Immunology’s article, “Cross-reactivity between quinolones,” it is noted that, “We conclude that cross-reactivity between quinolone seems to be very important, and avoidance of any quinolone should be recommended to any patients who has suffered an allergic reaction to one of these drugs.”

When I told my doctors at Kaiser Permanente that I wanted fluoroquinolones to be put in my chart as a drug allergy, they couldn’t do it, because “fluoroquinolones” are a class of drugs, and they could only enter individual drugs into their system. In order to get all fluoroquinolones in my chart, I had to list every fluoroquinolone separately, because if I just said that I was allergic to Cipro, they would still give me Levaquin, or Avelox or Floxin. That’s a bit ridiculous seeing as it says ON THE WARNING LABEL that if someone has a history of hyper-sensitivity to one quinolone, they should avoid exposure to other quinolones. I’m sure that it’s easier said than done, but couldn’t there be some sort of cross-population of information that takes the “clinically well documented” cross-reactivity of quinolones into consideration? If someone has experienced a severe adverse reaction to Floxin, they shouldn’t take Levaquin—it’s not that difficult a concept. But systems are not currently in place to recognize, much less track or prevent, cross-reactivity or contraindications between drugs.

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If a person experiences a severe adverse reaction to a fluoroquinolone and they feel as if a bomb has gone off in their body and mind, they know that they have had an adverse reaction to a quinolone. Going through one severe adverse reaction to a quinolone is enough for most people, and they are likely to realize that they should never take a quinolone again. However, there are many people who experience mild-to-moderate adverse reactions to quinolones who don’t realize that they have had an adverse reaction in the past.

For the people reading this who may have taken a fluoroquinolone in the past but haven’t had a severe adverse reaction, I encourage you to think about your health history. After taking Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin, did you experience any of the following?

Insomnia
Anxiety
Loss of endurance
Muscle twitches
Tendon tears or ruptures
Depression
GI issues
Mild peripheral neuropathy

Those are all Warning Signs of fluoroquinolone toxicity. After the first time I took ciprofloxacin I had a twitchy eyelid and intermittent stomach cramping. I wish I had known that those symptoms were adverse reactions to the ciprofloxacin, and that I had known that I could no longer tolerate it. If I had known that I had experienced an adverse reaction to ciprofloxacin in the past, and if I had known that the warning labels say that people who have had a bad reaction shouldn’t take the drug again, I wouldn’t have taken it again and I would have avoided full-blown fluoroquinolone toxicity. There are a million “if only” scenarios around my adverse reaction to ciprofloxacin. I can’t turn back time and change anything though. I can only move forward and warn people. I hope that people heed my warning, and connect bizarre, seemingly innocuous symptoms like anxiety and sprained elbows, to the fluoroquinolone they took to treat an infection, and that they avoid future use of fluoroquinolones.

 

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