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.