FDA Strengthens Warning for Antibiotics Side Effects

FDA Strengthens Warning for Antibiotic Side EffectsThe U.S. Food and Drug Administration (FDA) announced on August 1, 2016, that it is strengthening its warning on the labels of fluoroquinolone antibiotics, adding a black box warning for serious side effects that include potentially permanent damage to muscles, joints, tendons, nerves and the central nervous system.

Fluoroquinolones are the most popular antibiotics in the U.S. and are used in the treatment of bacterial infections. FDA-approved fluoroquinolones include Levaquin (levofloxacin), Cipro (ciprofloxacin), ciprofloxacin extended-release tablets, Avelox (moxifloxacin), ofloxacin and Factive (gemifloxacin).

In May 2016, the FDA issued a safety communication to healthcare professionals stating they should only use fluoroquinolones as a treatment of last resort for patients suffering from acute sinusitis, acute bronchitis and urinary tract infections. The FDA had issued warnings about fluoroquinolone side effects in 2008 and 2011, and in 2015, the FDA’s advisory committee ruled that the risks of fluoroquinolones outweigh the benefits when used for uncomplicated bacterial infections.

In addition, two 2015 studies linked fluoroquinolones to aortic damage that could lead to aneurysms and tears in the wall of the aorta. A JAMA (Journal of the American Medical Association) study associated the use of fluoroquinolones with a two-fold increase in the risk of aneurysm and aortic tears within 60 days of using the drug. A BMJ study found a three-fold increase in the risk of aneurysm from the use of fluoroquinolones.

In January 2016, Levaquin manufacturer Johnson & Johnson was sued for $800 million by five former Levaquin users who allege that J&J hid the side effects from patients and physicians.

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