FDA Strengthens Safety Label Warnings for Fluoroquinolone Antibiotics

The Food and Drug Administration yesterday announced safety labeling changes for fluoroquinolone antibiotics to strengthen warnings about the risk of mental health side effects and serious blood sugar disturbances. Based on a recent FDA review of adverse event reports and the medical literature, the updated labeling will highlight mental health side effects including disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium, and the potential risk of coma with hypoglycemia. Fluoroquinolone antibiotics are used to treat certain serious bacterial infections.
Related News Articles
Headline
AHA President and CEO Rick Pollack explains how hospitals have made meaningful progress in patient safety and delivering high-quality care, in a column…
Headline
The Administration for Strategic Preparedness and Response June 25 announced it conducted an exercise transporting simulated patients with high-consequence…
Headline
Ochsner Health's Stephen Saenz, sepsis program manager, and Teresa Arrington, director of robust process improvement for quality and patient safety, reveal how…
Headline
The AHA May 12 responded to the Office of Management and Budget's April 11 request for information on regulatory relief, making 100 suggestions to the Trump…
Headline
The U.S. has had 935 confirmed cases of measles so far this year, according to the latest data from the Centers for Disease Control and Prevention. Cases have…
Headline
There have been 8,064 reported cases of whooping cough in the U.S. so far this year, according to the latest data from the Centers for Disease Control and…