Seroquel Side Effects Lead to FDA Concerns About Expanded Use

A panel of outside advisors to the FDA will meet tomorrow to review whether Seroquel XR should be approved for wider use to treat depression and anxiety. The panel will weigh the benefits provided by the antipsychotic drug against concerns expressed by FDA officials that expanding the use of the drug will expose millions of more people to the serious and potentially life-threatening Seroquel side effects.

Seroquel (quetiapine fumarate), manufactured by AstraZeneca, is an atypical antipsychotic medication which was first approved for treatment of schizophrenia.

Last year, an extended release version of the drug, Seroquel XR, was approved by the FDA for treatment of bipolar disorders, and AstraZeneca is now seeking approval to market the drug for even wider use to treat conditions like depression and generalized anxiety disorder.

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This could expand the potential market for Seroquel from the approximately 8.1 million Americans currently suffering from bipolar disorder and schizophrenia, to nearly 30 million Americans if approval for depression and anxiety is granted.

The FDA has convened a panel of outside medical experts who will meet on April 8, 2009, to review AstraZeneca’s request for expanded uses and make a recommendation to the FDA about whether approval should be granted. While the FDA is not required to follow the recommendations of their advisory panels, they usually do.

According to documents prepared by FDA reviewers in advance of the panel meeting, Seroquel has been shown to be an effective treatment for depression and anxiety. However, the agency staffers express concern about exposing millions of more people to side effects of Seroquel, which have been shown to increase the risk of weight gain and diabetes, cause a debilitating facial movement disorder known as tardive dyskinesia, and potentially increase the risk of sudden heart death.

AstraZeneca currently faces thousands of Seroquel diabetes lawsuits filed by users who allege that the drug maker withheld information about the metabolic risks associated with the drug and failed to warn about the increased risk of weight gain and diabetes. During pretrial testimony, some experts have suggested that Seroquel increases the risk of diabetes by nearly four times when compared to older antipsychotics.

Use of Seroquel has also been linked to tardive dyskinesia side effects, which causes repetitive and involuntary movements of the face, such as tongue protrusions, lip smacking and rapid eye movements. The condition is socially disabling and symptoms of tardive dyskinesia often continue even after the drug is stopped.

The FDA scientists also expressed concerns about possible Seroquel heart side effects, as a recent article in the New England Journal of Medicine suggested that atypical antipsychotics can increase the risk of sudden cardiac death.


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