FDA revises warnings for oral and injectable fluoroquinolone antibiotics

The U.S. Food and Drug Administration has made changes to the labels for fluoroquinolone antibacterial drugs administered by mouth or injection to address potential serious safety issues. The revised “boxed warning,” the agency’s strongest warning, notes that the drugs are “associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system” that can occur together. “Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients,” the agency states. For more, see the FDA Safety Announcement.