Sunday, November 15, 2015

Guest blog: FDA Takes Notice of “Fluoroquinolone-Associated Disability”

*Guest blog written for Baron & Budd Law Firm. The original post can be found here:

Sinusitis, bronchitis and urinary tract infections are common infections that typically send patients to the doctor looking for relief.

Millions of prescriptions are written every year for fluoroquinolone antibiotics such as Avelox (moxifloxacin), Cipro (ciprofloxacin), and Levaquin (levofloxacin) in pill form, IV, and eye and ear drops. As the number of prescriptions have increased, so have the number of adverse reactions reported to the FDA. These adverse reactions encompass several body systems including the peripheral, autonomic, and central nervous systems, psychiatric, cardiovascular, musculoskeletal systems, and more.

The FDA is taking notice of this, and in a recent review, the FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.

Fluoroquinolones are incredibly powerful antibiotics with the capability to save lives when used appropriately as a treatment of last resort for life-threatening bacterial infections like anthrax. But these antibiotics also have the power to destroy lives when they are inappropriately prescribed for routine infections like sinus infections, uncomplicated UTIs, and bronchitis which don’t need their strength.

That is exactly what happened to me. I went to my doctor for treatment of a routine sinus infection and instead I was inappropriately prescribed an antibiotic that has disabled me.

On November 5, 2015, I was honored to testify at the FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. (You can watch the video from the meeting here.) The panel discussed the risk/benefit ratio of fluoroquinolone antibacterial drugs for the treatment of routine infections. I shared my story of how I was an otherwise healthy individual who was prescribed Levaquin for a sinus infection in 2006 and became disabled with ten tendon ruptures, peripheral neuropathy, cardiac problems, and a progressive neurodegenerative disorder from which I will never recover.  My sinus infection would have resolved had I been prescribed a safer alternative and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury.
And I was not alone. Thirty-four other people testified to their horrific injuries and disabilities, and some shared their emotional stories of having lost a loved one due to these dangerous antibiotics. We came together with the common goal of fighting for vital changes in how fluoroquinolones are prescribed to help save others from our fate.

We were heard and we made a difference. The panel agreed that the risks outweigh the benefits when fluoroquinolone antibiotics are inappropriately prescribed for routine infections. This is the first time that a government agency acknowledged how widespread the damage is. And that is huge.
The twenty-one member FDA panel voted 21-0 for a label revision on sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis. The panel did not recommend specific warning language because a decision on that matter would need to be made by the FDA. However, the FDA often implements panel recommendations and that is a reason for hope.

What happened to me, to everyone else who testified, and to everyone worldwide who could not be there in person was preventable. It is too late for us but not too late to save others. The FDA has a duty and a responsibility to protect the public and promote public health and therefore the FDA must apply its highest level of scrutiny, regulation and surveillance of fluoroquinolones to achieve that goal. We urge the FDA to implement the panel recommendations, strengthen warnings in clear language, and regulate fluoroquinolones so that they are only used in life threatening infections.
Anything less and more people will get hurt and that is not acceptable.

For more information about fluoroquinolones and our work at the Quinolone Vigilance Foundation, please visit our website

Rachel Brummert

About the Author:

Rachel Brummert is the Executive Director of the Quinolone Vigilance Foundation- In her position, she guides strategic planning for the foundation and acts as its spokesperson. As someone who has been personally impacted by quinolone toxicity, she oversees the implementation and evaluation of the organization’s programs, and promotes collaboration with researchers, donors, politicians, community groups, and others to further the organization’s mission.
The views expressed herein reflect the opinions of the author and do not necessarily reflect the views of Baron & Budd, P.C., its affiliates or its employees.

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