FDA AdComm Unanimously Recommends Change to Fluoroquinolone Label

November 12, 2015

An FDA advisory panel voted last week to recommend making changes to the label of fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, uncomplicated urinary tract infections and chronic bronchitis.

In a 21-0 margin, a joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee agreed that data on the risks and benefits of fluoroquinolones — one of the most potent FDA-approved drugs — do not support their use in treating acute bacterial sinusitis.

The panel also voted 20-1 that data on the risks and benefits for treating uncomplicated urinary tract infections was insufficient. It also voted 18-2 that the data was insufficient for chronic bronchitis.