The FDA asked AstraZeneca to halt distribution of a professional sales aid for its antipsychotic medication Seroquel.
In a warning letter to AstraZeneca, the FDA’s Division of Drug Marketing, Advertising & Communications division wrote that the Seroquel sales aid is misleading because “it minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia and the bolded cataracts precaution.”
Seroquel’s labeling says neuroleptic malignant syndrome, which can be fatal, has been reported in association of antipsychotic drugs, including Seroquel. AstraZeneca has until Nov. 30 to respond to the warning.
Seroquel had global sales of $2.8 billion last year.