Tag Archives: avelox warning label

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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Change the Warning Labels: Why it Matters

The warning label for Cipro/ciprofloxacin is already 43 pages long. It includes warnings about devastating adverse effects including irreversible peripheral neuropathy, destruction of weight-bearing joints, prolongation of the QT interval, seizures, severe hepatotoxicity, Stevens-Johnson syndrome, “psychotic reactions (that) have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide,” and more. Most of the symptoms of fluoroquinolone toxicity are already listed on the warning label. But when patients go to their doctors with symptoms of fluoroquinolone toxicity, they are often told that their reaction couldn’t be from the Cipro, Levaquin, Floxin or Avelox they took. To say that it’s frustrating that many doctors aren’t aware of the side-effects that ARE LISTED ON THE WARNING LABELS, is an understatement. It is shameful that the adverse effects listed on the warning labels aren’t known and quickly acknowledged by all medical professionals. It’s bad enough that many of those practicing medicine don’t know how to help people heal from fluoroquinolone toxicity, the fact that the symptoms that are listed on the warning labels aren’t often acknowledged, is horrible.

What’s the Point of the Warning Label?

It begs the question, if adverse-effects that are listed on the warning label aren’t being acknowledged, what is the point of the warning label?

One could argue that the only purpose of the warning label is to protect the pharmaceutical companies from being sued. After all, if you are hurt by a drug in a way that is listed on the warning label, most lawyers won’t take your case, and suing the drug companies for damage done is difficult to impossible.

Since patients are rarely given complete warning labels with their prescriptions for fluoroquinolones, and because the lengthy warning labels are still inadequate, and because the Learned Intermediary Doctrine makes it so that there are no requirements that patients even be informed about the consequences of taking prescription drugs, one could certainly argue that drug warning labels don’t protect consumers at all.

Citizen’s Petitions for Changing Fluoroquinolone Warning Labels

There are two citizen’s petitions that have been filed with the FDA asking for additional warnings to be added to the warning labels for Levaquin/levofloxacin (that would likely carry over to the other fluoroquinolones too). One of the petitions is for adding additional warnings of psychiatric adverse events, and the other is for adding “Possible Mitochondrial Toxicity” to the warning labels.

Since the existing warning labels are so inadequate for actually warning doctors or patients, and are actually counterproductive for patients seeking justice for the harm done to them, many people have asked, “What’s the point in adding anything to the warning label?” and they have asserted that adding more warnings to the labels isn’t what we should be aiming for.

In many ways, I agree with their assertions. If warning labels aren’t adequate or heeded, and if they actually get in the way of justice, we should be fighting for something other than more additions to the warning labels. We should be fighting for severe restrictions of these drugs, as well as true informed consent where all possible adverse effects are gone over with patients prior to administration of fluoroquinolones, similar to the restrictions put on Warfarin and Coumadin. We should fight for awareness of fluoroquinolone toxicity, so that doctors know about the possible harm they can do to patients with these drugs, so they can avoid doing that harm. We should fight for more research into fluoroquinolones so that the damage done by them can be more fully understood. We should fight for cures and assistance for those who have been hurt by fluoroquinolones. We should fight for justice, and more.

Many people and organizations ARE fighting for these things. Media outreach efforts are raising awareness and the doctors who are reached by these media reports are using fluoroquinolones more prudently. For example, it was reported that prescriptions for Levaquin/Levofloxacin dropped significantly after “Local woman says popular antibiotic killed her husband” aired and was shared more than 135k times on social media. The Quinolone Vigilance Foundation (QVF) works with scientists researching fluoroquinolones. Many people have written letters to their Representatives, the FDA and the AMA asking that stronger restrictions be put on fluoroquinolones. Several law firms are suing Bayer and Johnson & Johnson on behalf of fluoroquinolone victims. These things are all moves in the right direction.

Throwing a Punch at the Drug Companies

Receiving a positive response from the FDA to the Citizens’ Petitions is also a move in the right direction. Adding psychiatric adverse events and mitochondrial toxicity to the warning labels is actually a huge weapon for floxie advocates. Warning labels themselves may be useless, but during the time when a warning label has things added to it, they can be a great tool, and a big gun we can use against the pharmaceutical companies. The ONLY times lawyers are willing to take cases to sue the drug companies are when warning labels change. For example, when the fluoroquinolone warning labels were adjusted in August, 2013 to note that permanent peripheral neuropathy is a possible effect of fluoroquinolones, several law firms took cases of those who are suffering from peripheral neuropathy after taking fluoroquinolones. Before the warning label changed, they wouldn’t take the cases, because, appallingly, you can’t sue drug companies for hurting you, you can only sue them for “failure to warn” of the harm they’ll do. It’s a really stupid situation and stupid system. BUT, the time when warning labels change is the brief period of time in which you can sue the drug companies for “failure to warn” and it’s the brief period of time when we have the chance to fight the pharmaceutical companies. Opening this window is a good thing, and I support the Citizen’s Petitions because they are wonderful “window openers.” I hope that the FDA responds positively to them, and adds both psychiatric adverse events and “Possible Mitochondrial Toxicity” to the warning labels for all fluoroquinolones.

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If the window for justice can be opened by the Citizen’s Petitions, we may be able to throw a big punch that actually hurts Bayer and/or J&J. If psychiatric adverse events are added to the warning labels, ANYONE who has suffered from a psychiatric illness who had previously taken Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin or Floxin/ofloxacin can sue the drug companies that produce fluoroquinolones. That’s a lot of people who can, potentially, take a chunk of change out of Bayer’s and J&J’s pockets.

Mitochondrial toxicity is linked to many diseases, including all autoimmune diseases, neurodegenerative diseases, fibromyalgia, autism, CFS/ME, cancer, psychiatric illness, obesity, etc. Adding mitochondrial toxicity to fluoroquinolone warning labels opens the possibility for a HUGE punch to the pharmaceutical companies. If it is fully acknowledged that fluoroquinolones cause mitochondrial toxicity, anyone who comes down with a disease that is linked to mitochondrial toxicity can sue the manufacturer of the drug that hurt them. If everyone who got sick with a chronic disease who had previously taken a fluoroquinolone was able to sue Bayer or J&J, the drug companies would take note, and change may even occur.

It will be difficult for the FDA to claim that “possible mitochondrial toxicity” shouldn’t be added to fluoroquinolone warning labels. After all, it is stated IN THEIR DOCUMENT entitled, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” that:

Ciprofloxacin has been found to affect mammalian topoisomerase II, especially in mitochondria. In vitro studies in drug-treated mammalian cells found that nalidixic acid and ciprofloxacin cause a loss of motichondrial DNA (mtDNA), resulting in a decrease of mitochondrial respiration and an arrest in cell growth. Further analysis found protein-linked double-stranded DNA breaks in the mtDNA from ciprofloxacin-treated cells, suggesting that ciprofloxacin was targeting topoisomerase II activity in the mitochondria.”

THEY acknowledge that fluoroquinolones deleteriously affect mitochondrial DNA. The least they could do is put that information on the warning labels.

Movement…. Hopefully in the Right Direction

I obviously have a lot of conflicting feelings about changing the fluoroquinolone warning labels. I wish that we, as citizens who have been hurt by these drugs, had more opportunities for enacting change. I also wish that the warning labels were meaningful documents that were heeded by doctors and patients alike, and that they didn’t primarily serve the pharmaceutical companies. I also wish that more victims of fluoroquinolones were able to gain justice BECAUSE THEY WERE WRONGLY HURT BY A PRESCRIPTION DRUG, rather than making them jump through legal loop-holes about “failure to warn.” Until those things change though, we need to use the tools and opportunities we have. If enacted, the Citizen’s Petitions give us an opportunity to throw a big punch.

I hope that the FDA changes the warning labels to reflect what is known about fluoroquinolones causing mitochondrial toxicity and psychiatric adverse events.  If the warning labels change, and the punch behind the mitochondrial toxicity and psychiatric adverse events is big enough, maybe real change will occur. We can hope.

 

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Who Reads Drug Warning Labels?

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Here is a post that I wrote for Hormones Matter.

http://www.hormonesmatter.com/read-drug-warning-labels/

The information on the warning label for fluoroquinolones is woefully inadequate.  It’s sad how inadequate it is.

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