Seroquel is indicated for the treatment of acute manic episodes associated with bipolar disorder and for the treatment of schizophrenia.
According to the warning letter posted on the FDA Web site Wednesday, the sales material "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."
The drug's label says neuroleptic malignant syndrome, which can be fatal, has been reported in association with administration of antipsychotic drugs, including Seroquel.
The syndrome manifests as hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability, including irregular pulse or blood pressure, tachycardia and cardiac dysrhythmia.
The label also states that tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.
The FDA requested that AstraZeneca stop disseminating the material, adding that the company has until Nov. 30 to respond to the warning.
A company representative wasn't immediately available to comment.
Seroquel had global sales of $2.8 billion last year.
American depositary shares of the U.K. pharmaceutical giant recently traded at $57.48, up 18 cents, or 0.3%.
-Contact: 201-938-5400