New Fluoroquinolone Warning Labels

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Huge Gains in Fluoroquinolone Toxicity Awareness

In July, 2016, the FDA announced that major changes are to be made to the warning labels for all oral and IV fluoroquinolone antibiotics – Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and a few others. Not only is the FDA acknowledging the devastating effects of fluoroquinolones, they are warning people, in the highlighted black-box warning section, that fluoroquinolones are connected with, “disabling and potentially irreversible serious adverse reactions that have occurred together.” This acknowledgement from the FDA is a HUGE step in the right direction.
The updated black-box warning for Cipro/ciprofloxacin states:

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including CIPRO®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture 
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions, reserve CIPRO for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis
The other updates to the Cipro/ciprofloxacin warning label can be viewed HERE.
The other updates to the Levaquin/levofloxacin warning label can be viewed HERE.
The other updates to the Avelox/moxifloxacin warning label can be viewed HERE.
Many people worked very hard for this acknowledgement from the FDA, and it should be celebrated as a major victory. As our good friend Chandler Marrs from www.hormonesmatter.com noted:
“Who’s to say the experts know more than the patients? They don’t. This took years of patients speaking out, all the while the experts were silent. I am so impressed with the folks who were ill themselves, but still managed to launch a movement that was finally recognized by the FDA. Though there is still much to do, their stories and their struggles provide a guide to others. Suffering in silence does no one any good. Speak out.”
You can read more about the hearing at the FDA and some of the testimonies presented HERE and HERE.
I am hopeful that physicians and patients alike will read, and heed, the updated warning label. I certainly wish that I had known that ciprofloxacin could cause “disabling and potentially irreversible serious adverse reactions that have occurred together” before I took those pills. Perhaps if I had known what serious and severe drugs fluoroquinolones are, I never would have taken them, and I never would have gotten “floxed.”
The battle for fluoroquinolone safety, and care for the people who have been hurt by these drugs, is far from over. However, this updated warning label is a significant victory in a battle, and I am certainly pleased.
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In totally unrelated news, I got married! Most of you don’t know me, so I’m not going to dwell on it too much, but I will note that when I first got floxed I didn’t know if I would be able to find love, or have healthy relationships, ever again. Life goes on though, and healing happens. I met a wonderful man about two years post-flox, and we got married on July 30th of this year. For those of you who think that you’ll be sick and stuck forever because your sick now, just know that others have found healing, and love, post-flox. I hope that my success in both areas gives you hope!
You can see a picture from my wedding HERE.

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Resources

Links to hundreds of articles about fluoroquinolones and fluoroquinolone toxicity can be found on the Links & Resources page of floxiehope.com.

Some books, and a link to a documentary about fluoroquinolone toxicity, can be found HERE.

The facebook group, The Fluoroquinolone Toxicity Group, is full of wonderful and supportive people.

The ebook, The Fluoroquinolone Toxicity Solution, has helped many people through fluoroquinolone toxicity, and it is a good guide.

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