FDA Adverse Event Data Clouds Potential Fluoroquinolone Label Changes

FDA's advisory committee on fluoroquinolones left the agency with a dilemma – members voted current safety labeling is not sufficient, but also were unsure how best to incorporate new information in the label.

So while many advisory committee members felt something should be said about fluoroquinolone-associated disability, they also advocated for more research to better define the condition during the Nov. 5 joint...