Letter from Bayer to Doctors Regarding Cipro and Avelox

bayer-letter1

bayer-letter2

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.

 

flu tox get help you need banner click lisa

 

Tagged: , , , , , , , , , , , ,

20 thoughts on “Letter from Bayer to Doctors Regarding Cipro and Avelox

  1. girardia October 17, 2016 at 7:48 am Reply

    H O O R A Y!

  2. Barbara Arnold October 17, 2016 at 8:00 am Reply

    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.

    • Jackie Bragdon June 25, 2017 at 11:32 pm Reply

      Your anger and sense of injustice are 100% valid. I share the same feelings, and I don’t want to, but it’s all so overwhelming. I am praying for all of us.

      • L June 26, 2017 at 9:09 am Reply

        IT says “Dear Health Care Provider,” BUT are they actually SENDING these letter? Judging from doctors I have spoken to, and the fact many are STILL prescribing for simple infections, they are NOT. I wish someone could sue them into coming up with a way to fix all the people they have broken.

  3. Sandy October 17, 2016 at 8:02 am Reply

    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.

  4. Nicole Reedy October 17, 2016 at 9:15 am Reply

    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

    • Debs October 21, 2016 at 7:48 am Reply

      Also NO notification OR updated warning for our ignorant ( wilful or otherwise) clueless Drs in the UK either.
      Our useless drug regulatory agency The MHRA, corrupt as hel as I call them, aka little FDA KNOW because we told them, yet they will NOT act on this information, just say they want MORE evidence, more FQing evidence ? !!!!!!!!!!!!!!!! . how much more do they need ! the only thing more serious than permanent irreversible injury is DEATH, & of course FQs also tick the box there .

      The MHRA with their corrupt revolving door re employment, Big Pharma backed & headed by ex Glaxosmithkliene, they are living on a different planet, in a different universe, with a different reality system. Ignoring this updated warning has nothing to do with the fact that the fox is guarding the henhouse then ? … SMH ( bang head against wall )

      • Barbara Arnold October 22, 2016 at 2:12 am Reply

        Hi Debs,
        I’m British but live in Spain. I have tried to find a lawyer No Win No Fee, but it’s impossible here. I wondered if the medical negligence No Win No Fee lawyers in the Uk would be interested in a “Failure to Warn” as in the states a woman won a case under those terms. It’s on this website. It would only take one person to kick this off and that would open the door for others. I just can’t get my head around NO-ONE being accountable.
        I have written to BAYER in the UK and they have emailed me to fill in a form and a space to ‘Report’ what happened to me. Needless to say I am going to give it to them straight between the eyes. In my opinion if we all kept doing things like this it may get picked up by the media more.
        I cry a lot for myself, but also for you all. This is just so WRONG.
        HUGS.

  5. L October 17, 2016 at 9:22 am Reply

    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?

    • Barbara Arnold October 17, 2016 at 9:43 am Reply

      L….totally agree with you. Lets do it

  6. Nicole Reedy October 17, 2016 at 9:34 am Reply

    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!

    • L October 17, 2016 at 10:14 am Reply

      yeah, most of the doctors I saw only knew about the tendon issue, and a couple didn’t even know about that!!! This information is not getting to the doctors, and I am guessing the sales reps aren’t helping in that regard.

  7. Petros October 17, 2016 at 10:11 am Reply

    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?

    • L October 17, 2016 at 10:16 am Reply

      My friend who travels a lot always is given Cipro by her doctor. I begged her to ask for something else. These are the ONLY family of antibiotics that can cause permanent damage, as far as I know. NOT WORTH IT.

    • Lisa October 17, 2016 at 8:09 pm Reply

      It is criminal that FQs are prescribed prophylactically for travelers’ diarrhea. People don’t even have travelers’ diarrhea when they are prescribed the Cipro. To dispense such a powerful and disabling drug “just in case” is disgusting. I’m so sorry for all that you’ve been thorough, Petros!

  8. […] Source: Letter from Bayer to Doctors Regarding Cipro and Avelox […]

  9. […] Letter from Bayer to Doctors Regarding Cipro and Avelox HT Lee Wardlaw […]

  10. Claw February 6, 2017 at 8:41 am Reply

    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????

    • L February 6, 2017 at 11:25 am Reply

      BAYER has known for decades. I think the ONLY reason for this letter from them is to try to protect themselves from liability. Period. They will still not spend one penny trying to figure out how to fix all of us. (I also wonder too if it actually gets SENT to doctors, or if, like the FDA warnings, they are just put out there into the atmosphere

    • L February 6, 2017 at 11:37 am Reply

      Hey—maybe we should all write Mirski, and let him know that WE know that THEY have known for decades and demand compensation

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: