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.
H O O R A Y!
To little to late. At least it’s begining to circulate. What about the rest of the world, is this evil company going to send information to all the other countries. What about where I live, Spain ???
I have just written to Bayer in England, but I’m not sure it counts as I live in Spain.
This has to be a WORLD WIDE INSTRUCTION.
As much as I try, I can’t seem to shake off the anger I feel at the injustice of it all, and NO ACCOUNTABILITY FROM ANYONE. I know this is not good for me, but no amount of meditation etc can stop these feelings of my life and other being taken away because of greed and profit.
Sorry about my rant.
I will print this off and take into my local pharmacy alongside all the other stuff I took in. I would like to take it to my Doctor but he doesn’t speak English and it’s to expensive to get a translation. I will definately take it to the rheumatologist who treated me with such arrogance, the cow may think twice now.
Beyond speechless! This is huge! We need to forward this email to friends and family today! Continue to get the word out on these horrific antibiotics. Lisa, many thanks to you for your leadership, tenacity, strength and hope….you fight for all of us.
I am with Barb I am afraid. Too little to late!!!!
Because of the web and people like you Lisa they have to cover their rears but should have years ago!!!!
And like Barb, no black box warnings in Canada! Just crazy looks from doctors & chemists when you try to tell them your story. Then really crazy….looks when all your tests come back normal!!!!!
So after spending a fortune with a NP and not really getting anywhere but just a trade off of symptoms back and fourth, thinking maybe I am nuts!!!!
So here I am seeing a psychologist over this poison! Before you think I am doing this because I really think all of this is in my mind, I do not!!!! I am seeing her to learn how to deal with this life and keep from killing myself or all my doctors & chemists! LOL
I think this is just more “save their butts” paperwork. Will any actually go out to all physicians? I doubt it. And I think we should all write to Dr Dario F Mirski, who signed it and ask him why the hell they don’t spend some money trying to figure out how to fix all the people they have broken?
Amen L!!!! The day they try to find a way to fix the damage I will rejoice!!!!
I have talked to to many people who ask their doctors how they feel when they see these warnings & they go, oh yes, I saw something about tendons!!!! They don’t even read it!!!
I take my doctors the information & tell them they can read, believe it or throw it the trash but here it is. I am sure it just goes in my file and no one ever looks at it!
I took Cipro for traveler’s diarrhea, and unfortunately, it is not listed. So does that mean that travel clinics should continue to prescribe Cipro willy nilly?
After my first trip to Africa in 1998, I told my MD that I had diarrhea for about 2-3 weeks after my trip. His response was to ask me why I suffered when I could just take the Cipro he prescribed. So after that, I did as he suggested, and took Cipro, even though I had a perfectly good strategy for dealing with diarrhea (fasting).
Yesterday, I layed some patio stones. By the end, I could barely bend over to pick things up off the ground, my shoulders were sore–I basically felt sore everywhere.
Is 15 years of disability and pain less than 2-3 weeks of diarhea?
Yes this is a huge step forward. So now they’re admitting this can cause serious damage, what is the monetary and emotional compensation for those of us who have been damaged? The financial impact from having to quit my job? They’ve profited off of us, where is the money to pay for therapy for our irreversible damage????
TOLD YOU THERE WAS A LETTER!!!!
This makes me furious and sad at the same time. I was prescribed Cipro in 2008. My life has fallen apart since. I now have chronic pain, Raynaud’s, small fiber neuropathy and most recently Ehlers Danlos. They are also looking at mitrocondroial disease. I can’t find my records of where it was prescribed now. That year is “missing” from my pharmacy. No one will ever be held accountable for my suffering and that my quality of life is gone.
Can I get a copy of this letter as a scanned photo not just a selfie? I’d love to make copies for my doctors!!
I was prescribed 4 weeks worth of Cipro in December 19 so not much seems to of changed. For a suspected prostrate infection even though it wasn’t confirmed. No warning whatsoever just told me to collect three boxes full from the pharmacy. Haven’t took them obviously as was too scared following taking them in 2014.
Too late for my sister. Her husband was prescribed Avelox for a suspicion of pneumonia. He took 2 pills and died on the living room floor of an aortic aneurysm. Never smoked. Never drank…not even wine, exercised and was healthy. October 26, 2017. ????
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