FDA Warning - Material Regarding Seroquel is “Misleading”
The U.S. Food and Drug Administration (FDA) has issued a letter to AstraZeneca, the manufacturer of Seroquel (quetiapine fumarate) stating that a piece of promotional material for Seroquel tablets is false or misleading and requesting that AstraZeneca “immediately cease the dissemination of violative promotional materials for Seroquel.” According to the letter,
“This piece is false or 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 … The promotional material raises significant public health and safety concerns through its minimization of the risks associated with Seroquel.”
Seroquel is an atypical antipsychotic medication that is FDA-approved for the treatment of acute manic episodes associated with bipolar disorder and for the treatment of schizophrenia. It is also sometimes prescribed off-label for headache and migraine prevention.
In 2003, following review of the data available regarding the use of atypical antipsychotic medications and diabetes adverse events, the FDA asked the manufacturers of these medications to include a warning in their patient information regarding the risk. AstraZeneca complied with that request. In question is information now being presented in promotional materials for Seroquel. AstraZeneca has until November 30, 2006 to comply with the conditions set forth in this warning letter.