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Warning from the FDA

FDA Updates Warnings on Fluoroquinolones

Fluoroquinolones, such as levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive), are antibiotics that effectively treat serious bacterial infections, but are also associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. The FDA has updated warnings on these medications to alert providers and patients about the risk of disabling and potentially irreversible adverse reactions The FDA warns that fluoroquinolones should only be used to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections when there are NO other treatment options.

This most recent update to the labeling follows the safety warnings added in 2008 about associated increased risk of tendinitis and tendon rupture, in 2011 about the risk of worsening symptoms for those with myasthenia gravis, and in 2013 describing the potential for irreversible peripheral neuropathy (serious nerve damage). In November 2015, an FDA Advisory Committee considered research that focused on two or more side effects occurring at the same time and causing the potential for irreversible impairment and concluded that the serious risks associated with the use of fluoroquinolones for uncomplicated infections generally outweighed the benefits for patients with other treatment options. There are some serious bacterial infections, including anthrax, plague and bacterial pneumonia, where the benefits of fluoroquinolones outweigh the risks.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”


Byline: Martha L. Sikes, MS, RPh, PA-C

Posted: August 16, 2016

Source: U.S. Food and Drug Administration (FDA)
Adapted from the original press release.

[Image: Pixabay / Geralt]

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