FDA panel outlines risks for new Seroquel indication

The FDA said today that clinical data for AstraZeneca's Seroquel XR (quetiapine) demonstrates the drug was effective at treating depression and anxiety, but trial results also show evidence of "substantial metabolic risk." Seroquel is currently approved to treat bipolar disorder and schizophrenia. The agency released a written review of AstraZeneca's Seroquel XR ahead of the April 8 Psychopharmacologic Drugs Advisory Committee meeting to evaluate the drug for the treatment of major depression and generalized anxiety disorder. With evidence that longterm use may cause weight gain, diabetes and increase heart risks, "we need to think carefully about the risks and benefits of such expanded use," the FDA said. 

Also on the agenda for next week's panel discussion are concerns regarding the risk of sudden cardiac death associated with atypical antipsychotics and tardive dyskinesia, a movement disorder known to be caused by longterm exposure to the drug. The risk of tardive dyskinesia is accepted in bipolar and schizophrenia populations and may in fact be reduced by atypicals, the agency says, but it's important to evalute the longterm risks associated with exposing a much broader patient population to the disorder. 

The memo authors say that Seroquel XR's safety profile for depression and anxiety appears to be the same as for schizophrenia and bipolar disorder, but they will recommend strengthening Seroquel's label to address metabolic risks and ask AZ to respond to concerns about tardive dyskinesia.

Seroquel XR is one of AstraZeneca's top-selling drugs, with 2008 sales reaching $4.45 billion. But the drug has been the center of controversy for some time. AZ is now defending itself against lawsuits from nearly 15,000 Seroquel users who say the drug caused them to develop diabetes. Plaintiffs in that case say company documents show that AZ was aware of the diabetes risk and sought to cover it up. And just last month the Washington Post uncovered buried data on Study 15, a trial that found that participant gained 11 pounds a year while taking Seroquel and four out of five patients stopped taking the drug.

- read the WSJ article for more
- check out the AP's take

ALSO: AZ has gained approval in Ireland to market Seroquel XR for bipolar disorder. Report

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