Due to its worrisome side effects, federal health experts declared that Seroquel should not be a first choice to treat depression. Seroquel is made by AstraZeneca, and is approved as a treatment for schizophrenia and bipolar disorder. However, AstraZeneca is seeking FDA approval for Seroquel to treat depression and anxiety disorder. Such approval would expand the market for Seroquel to include the 20 million U.S. patients that suffer from depression and anxiety. FDA advisors found that Seroquel did not have a clear advantage in efficacy. Seroquel’s side effects include weight gain, high blood sugar and potential heart problems, and federal regulators hesitate to expose nearly 10 percent of the U.S. population to such a drug. However, the FDA advisory panel indicated that Seroquel could be a useful supplemental treatment for depression when other antidepressants are not effective. The panel did not vote on whether Seroquel could be a supplemental therapy for anxiety disorder.
Usually the FDA follows the advice of its expert panels, though it is not required to do so. A recent study by researchers at Vanderbilt University found that newer atypical antipsychotics carry the same risk of death from sudden heart problems as older antipsychotics. That study was published in the New England Journal of Medicine. AstraZeneca cannot market Seroquel as a treatment for anxiety and depression, but doctors already prescribe it for such uses.