Monthly Archives: October 2016

Letter from Bayer to Doctors Regarding Cipro and Avelox

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The above letter, from Bayer to health care professionals reads:

August 22, 2016

IMPORTANT DRUG WARNING

Subject: Important Changes in the Avelox (moxifloxacin hydrochloride) and Cipro (ciprofloxacin) Complete Prescribing Information – New Limitations of Use and Safety Information for Fluoroquinolones

Dear Health Care Professional:

Bayer HealthCare Inc. and Merck & Co., Inc. would like to inform you of imprtant changes to the prescribing information for fluoroquinolone antibiotics for systemic use in the United States, including Avelox (moxifloxacin hydrochloride) and Cipro (ciprofloxacin).

Limitation of Use and Safety Information for Fluoroquinolone Drugs

To communicate important safety information for fluoroquinolone antibiotics, the U.S. Food and Drug Administration (FDA) has requested that all license holders of these products, including Bayer for Avelox and Cipro, implement a class label change.

These labeling changes provide for revisions to the Indications and Usage section of the package insert to include a new limitation of use statement for acute bacterial sinusitis, uncomplicated urinary tract infections, acute uncomplicated cystitis, and acute bacterial exacerbation of chronic bronchitis, to reserve systemic fluoroquinolones for treatment in patients who have no alternative treatment options. In addition to the Boxed Warning, Warnings and Precautions, and Information for Patients sections of the package insert and the Medication Guide have been revised to include information regarding the risk of disabling and potentially irreversible serious adverse reactions of tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects that can occur together in the same patient.

The labels of fluoroquinolones already had a Boxed Warning for tendinitis, tendon rupture, and worsening myasthenia gravis. The labels also included warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity adverse reactions. This information about the risk of disabling and potentially irreversible serious adverse reactions is based on the FDA’s review of postmarketing adverse event reports from the FDA Adverse Event Reporting System (FAERS). This safety information was discussed at a November 5, 2015 joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Prescriber Action:

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, acute uncomplicated cystitis, and uncomplicated urinary tract infections. Health care professionals should encourage patients to read the Medication Guide that describes the safety issues associated with fluoroquinolones. The Medication Guide is required to be given to the patient with each fluoroquinolone prescription. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Reporting Adverse Events:

Health care professionals are encouraged to report adverse events to FDA’s MedWatch reporting system by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

If you wish to request further information for AVELOX, please contact Merck National Service Center at 1-800-526-4099. If you wish to request further information for CIPRO, please contact Bayer Service Center at 1-888-842-2937.

Please refer to the accompanying Important Information about AVELOX and CIPRO for complete indication and other important risks. Please also see the enclosed Prescribing Information, including BOXED WARNINGS and Medication guide for AVELOX and CIPRO.

Bayer HealthCare is the license holder for AVELOX and CIPRO. Under terms of a marketing agreement, Merck markets AVELOX in the United States.

Sincerely,

Dario F. Mirski, M.D.

Senior Vice President and Head Medical Affairs Americas

Bayer HealthCare Pharmaceuticals, Inc.

Enclosures: AVELOX and CIPRO Full Prescribing Information

 

The Avelox and Cipro prescribing information can be found HERE and HERE.

 

I’m honestly feeling speechless right now–I have no idea how to respond to this. The letter speaks for itself. I never thought I would see the words, “Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, acute uncomplicated cystitis, and uncomplicated urinary tract infections,” or that doctors and patients alike should be warned of “disabling and potentially irreversible serious adverse reactions” of fluoroquinolones, or that, “the risk of disabling and potentially irreversible serious adverse reactions of tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects that can occur together in the same patient,” from Bayer. But, there it is, on Bayer letterhead–a letter to health care professionals regarding the real, serious, often permanent risks of fluoroquinolones.

I hope that this letter is being distributed far and wide, and that it reaches every doctor, P.A., nurse, and other medical provider in the country.

I hope that Johnson & Johnson sends out a similar letter regarding Levaquin (levofloxacin).

I hope that doctors heed these warnings, and stop prescribing fluoroquinolones outside of life-threatening situations.

I hope that these letters do something other than mitigate the risks and losses that Bayer anticipates from lawsuits having to do with the updated Cipro and Avelox warning labels.

I hope that some of the motivation for this letter is Bayer wanting to do the right thing and warn patients and health care providers alike about the dangerous side-effects of their drugs.

I hope that we in the “floxie” community can celebrate this. I see this letter as a very big deal. When I started this site in 2013, I didn’t think that I would ever see a letter like this. It, along with the warning label changes that prompted it, should be celebrated.

 

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Children are Being Hurt By Fluoroquinolone Antibiotics

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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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Filing a Complaint with your State Medical Board

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Iatrogenic Damage

Everyone who is suffering from fluoroquinolone toxicity has been hurt by the medical system–obviously. A prescription drug, an antibiotic no less, caused a multi-symptom illness that includes damage to connective tissue (tendons, ligaments, cartilage, muscle, fascia, etc.) throughout the body, damage to the nervous systems (central, peripheral and autonomic), and more, for those who are “floxed.” There are thousands of people who suffer from a myriad of adverse-effects as a result of taking Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, or other fluoroquinolone antibiotics. Despite the devastation that fluoroquinolones bring to their victims, and the fact that most symptoms are documented in various studies and on the FDA-published warning label, most victims of fluoroquinolones are unable to gain any sort of justice, retribution, or compensation for the damage done to them.

Justice System Failure

“Why don’t you just sue?” is a question that is commonly asked. While a complete answer to this question is more than I can give in this post, the short 2-part answer is that: A) People who are hurt by generic drugs cannot sue the maker of the drugs that hurt them, and B) If a symptom is listed on a drug warning label, you cannot sue for the drug causing that symptom. Most symptoms of fluoroquinolone toxicity are listed on the 43-page drug warning label, so if, for example, you suffer from toxic psychosis after taking a fluoroquinolone, you cannot sue for that severe and life-altering effect because “you were warned.” Never mind that few victims, and almost equally few medical professionals ever read the drug warning labels, much less the studies behind them.

Because suing is near-impossible for most victims of fluoroquinolones, thousands of people are left without any sense of justice or compensation for their losses.

What are fluoroquinolone-victims supposed to do? How are they supposed to get any sense of justice, retribution, or even acknowledgment or change?

Justice through State Medical Boards?

A recent note from a floxie friend gave me hope that some acknowledgement, and maybe some change, could come through filing complaints against the doctors (and other medical professionals) who are prescribing fluoroquinolones. Here’s her story:

My friend was an active senior citizen who enjoyed dancing before she was floxed. She is a petite vegan and was entirely healthy before she took ciprofloxacin. My friend recently filed a complaint with her State Medical Board against the Physician Assistant who prescribed her ciprofloxacin to treat an unconfirmed urinary tract infection. Her complaint asserted that the P.A. misdiagnosed her with a urinary tract infection and improperly prescribed fluoroquinolone antibiotics “which resulted in long term complications” (i.e. she got floxed).

My friend was pleasantly surprised when she received a letter back from the State Medical Board stating that they found that the P.A. was guilty of a “simple departure” from the standard of care. The letter explained that a simple departure from the standard of care is a “departure from the standard of practice,” and that “there must be two or more negligent acts or omissions before there is a violation of the Medical Practice Act.”

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Basically, this P.A. now has one strike against him, and if there is another Medical Board complaint against him, he can be found to be in violation of the Medical Practices Act, and disciplinary action can be taken.

Though I don’t know how the P.A. reacted to the findings, it is reasonable to assume that he isn’t happy about having one strike (of two) against his record. I would also guess that he’s not going to prescribe fluoroquinolones for unconfirmed UTIs (it turned out that my friend didn’t even have bacteria in her urine), and maybe he will refrain from prescribing fluoroquinolones again unless they are completely medically necessary. This, in itself, is progress. Having fewer doctors, P.A.s, and other medical professionals prescribing fluoroquinolones is a step in the right direction.

With the letter from her State Medical Board, my friend is approaching lawyers to see if any will take her case against the P.A. who prescribed her ciprofloxacin.

Perhaps filing complaints with State Medical Boards, and suing, doctors who hurt people through prescribing fluoroquinolones is one way to get change to happen.

Changing the System

If there are consequences for prescribing fluoroquinolones, perhaps more doctors will be cautious and prudent with them. If doctors hear of their associates having Medical Board disciplinary action taken against them, perhaps they will take the well-documented side-effects of fluoroquinolones seriously.

Fluoroquinolones are serious drugs with severe consequences. They should be prescribed with care and prudence, and, when they’re not, those who prescribe them inappropriately should face consequences.

If you were prescribed a fluoroquinolone inappropriately (the FDA recently changed the warning labels to note that fluoroquinolones should not be prescribed to treat bronchitis, uncomplicated cystitis, or sinus infections, and there are also documented reasons that athletes, children, people taking steroids or NSAIDs, immunocompromised individuals, and those with a history of psychiatric illness, should not be prescribed fluoroquinolones), your doctor should be reprimanded for inappropriately prescribing dangerous drugs to you–especially if those drugs hurt you.

I encourage everyone who was inappropriately prescribed fluoroquinolones to look into filing a complaint with your State Medical Board against the person who prescribed fluoroquinolones to you. Each State Medical Board has different forms and procedures, but you should be able to access them through Googling, “____(your State) Medical Board.”

I also encourage those whose fluoroquinolone side-effects were disregarded or ignored by doctors to file complaints with their State Medical Boards. The wide-ranging side-effects of fluoroquinolones are well-documented (HERE are hundreds of articles about the dangers of fluoroquinolones), and denial of documented drug side-effects is not appropriate. Perhaps with some Medical Board complaints, more acknowledgement of fluoroquinolone effects will come as well. That would certainly be nice, as acknowledgment is healing.

My friend has been empowered by the Medical Board findings, and I hope that she eventually gets justice. Disabling people with strong and consequential drugs, especially when they don’t even have an infection to begin with, is wrong. All “floxies” have to pay the consequences of taking fluoroquinolones with every loss that they sustain. Perhaps some of that burden should be shared by the doctors who inappropriately prescribe fluoroquinolones.

 

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