FDA Revises Boxed Warning for Fluoroquinolones, Says Risks Outweigh Benefits in Some Patients

WASHINGTON, D.C. — The Food and Drug Administration says it has revised the boxed warning for fluoroquinolone antibacterial drugs for systemic use to state that the drugs should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in those patients.

In a July 26 Safety Alert, the agency noted that fluoroquinolones are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that …