FDA Panel Advises Stronger Warnings on Fluoroquinolones Save
An FDA Advisory Panel reviewed the safety of fluoroquinolones and their use to treat sinus infections, urinary-tract infections and bronchitis.
The panel unanimously voted in favor for revision of the product label to more adequately portray the changing safety profile of this class, that includes Cipro and Aveloz.
These antibiotics have been available for more than 30 years and In 2014 they were prescribed to more than 36 million Americans according to IMS Health.
The panel reviewed several specific safety issues, including the risk of cardiovascular disease (conduction disturbances), tendon rupture, cognitive dysfunction and disabling peripheral neuropathy. Based on data presented and presentations from affected individuals, the vote favoring revision of the labels was 21-0 on sinusitis; 18-2, with one abstention, on bronchitis; and 20-1 regarding urinary-tract infections.
The FDA is now considering how to act on these recommendations.
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