FDA requires labeling changes for systemic fluoroquinolones – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
FDA has required class-wide safety labeling changes for oral and injectable fluoroquinolones to strengthen the warnings about the risks of adverse effects, including effects on mental health and blood glucose metabolism. A comprehensive review of FDA’s adverse event reports and case reports in the medical literature led to the requirement.
The requirement stipulates that mental health adverse effects such as disorientation, agitation, nervousness, memory impairment, delirium, and disturbances in attention are to be listed separately from other central nervous system adverse effects on the label. Although current labeling notes blood glucose disturbances such as hyperglycemia and hypoglycemia, the labeling for all systemic fluoroquinolones must now explicitly state the potential risk of coma from hypoglycemia. FDA also issued a drug safety communication for patients and health professionals about hypoglycemic coma and mental health adverse effects associated with fluoroquinolones.