FDA Advisers Recommend Stronger Warnings on Fluoroquinolones

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

An FDA advisory panel voted late last week to recommend stronger label warnings on fluoroquinolones (e.g., ciprofloxacin) when used to treat sinus infections, urinary tract infections, and bronchitis that complicates preexisting chronic obstructive pulmonary disease, the Wall Street Journal reports.

Safety concerns include increasing reports of cardiac rhythm disturbances, peripheral neuropathy, and cognitive problems associated with the antibiotics. Some patients have reported permanent side effects.

The panel voted 21-0 to update the warnings for sinusitis treatment, 18-2 (1 abstention) for bronchitis, and 20-1 for urinary tract infections. The FDA usually follows its advisers' advice, although it is not required to do so.

Asked to comment, infectious disease expert Dr. Paul Sax said: "While fluoroquinolones are usually safe, there is an increasing appreciation that rarely they may cause severe and sometimes permanent side effects. The additional warnings will be a reminder that no antibiotic should be used unless clearly indicated."