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FDA Panel Votes for Stronger Warnings on Antibiotics


November 6, 2015 — An expert panel to the FDA has voted that fluoroquinolone antibiotics like Levaquin and Avelox need stronger warnings about serious side effects, according to The Wall Street Journal.

The panel nearly-unanimously voted that current labels do not adequately warn about the risks of prescribing a fluoroquinolone for some of the most common sinus, lung, and urinary tract infections.

Investigators reviewed the FDA database of adverse events and published a report (PDF) ahead of the meeting. Fluoroquinolone antibiotics were linked to 178 cases of Fluoroquinolone-Associated Disability (FQAD), a “constellation of symptoms” that typically involved long-term pain, musculoskeletal events (tendon, joint, and/or muscle problems).

More than 30 individuals spoke at an open public hearing about their experiences with these side effects. Many described severe disability and decreased quality of life, according to MedScape Medical News.

According to the panel, fluoroquinolone antibiotics are associated with FQAD and the label should be revised:

“While the individual components are included in fluoroquinolone labels, a description of the constellation of disabling adverse events is not currently described in the fluoroquinolone labels.”

The FDA does not have to follow the panel’s recommendations, but it often does. In recent years, labels have been updated to include side effects like peripheral neuropathy (nerve damage), tendon injuries, cognitive problems, and more.


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