FDA Warning on Seroquel Advertising

The Food & Drug Administration has issued a warning letter to AstraZeneca, maker of Seroquel, saying its promotional material is “false or misleading” and “raises significant public health and safety concerns through its minimization of the risks associated with Seroquel.”

Seroquel (quetiapine fumarate), an atypical antipsychotic, is marketed as a treatment for schizophrenia and bipolar disorder. However, it is often prescribed for anxiety and sleep disorders. Though used to mitigate such health issues, the drug has been linked to the development of diabetes, a debilitating, deadly disease.

In its letter to AstraZeneca, the FDA’s Division of Drug Marketing, Advertising and Communications cited grave concerns over one of the drugmaker’s professional sales aides, which it says “minimizes the risk of developing hyperglycemia and diabetes mellitus” as a result of taking Seroquel. The FDA also criticized the pharmaceutical giant for failing to communicate important information regarding the drug’s other label precautions. In light of such omissions, the FDA found AstraZeneca in violation of the Federal Food, Drug, and Cosmetic Act and requested that it “immediately cease the dissemination of violative promotional materials.”