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 Food and Drug Administration issued Class I recalls, the most serious type, for two Smiths Medical infusion pumps due to the potential for serious injury…
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
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
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…