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.
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.
Dario F. Mirski, M.D.
Senior Vice President and Head Medical Affairs Americas
Bayer HealthCare Pharmaceuticals, Inc.
Enclosures: AVELOX and CIPRO Full Prescribing Information
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.
Tagged: Avelox, Avelox side effects, avelox warning label, Bayer, Cipro, Cipro side effects, cipro warning label, ciprofloxacin, dear doctor, Fluoroquinolone toxicity, fluoroquinolone warnings, letter from bayer, moxifloxacin