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
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 Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride…
Headline
The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports…
Headline
The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi. BD identified an increase in material fatigue…
Headline
The Government Accountability Office yesterday released a report calling for the Department of Health and Human Services to improve its efforts responding to…
Headline
The AHA Living Learning Network is launching the Quality Exchange, a virtual collaborative for health care quality and patient safety professionals at…