FDA Panel Snubs Seroquel as 1st Choice Depression Treatment

Safety concerns mean the drug should only be used when other medications don't work, advisers say

By Randy Dotinga and E.J. Mundell
HealthDay Reporters

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WEDNESDAY, April 8 (HealthDay News) -- In a unanimous vote, a U.S. Food and Drug Administration advisory panel determined Wednesday that AstraZeneca's antipsychotic drug Seroquel has too many safety concerns to make it a first-line treatment against depression or anxiety disorders.

However, in a separate 6-to-3 vote, the panelists recommended that the medication could be used as supplemental treatment for patients with depression who do not get symptom relief from other drugs, the Associated Press reported. The expert panel did not hold a similar vote for anxiety disorders.

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Overall, "I saw no clear advantage demonstrated in efficacy," said Dr. Wayne Goodman, the panel's chairman and a psychiatric researcher at the U.S. National Institutes of Health. "There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug."

The FDA is not mandated to follow its advisory panels' advice, although it usually does. Federal health officials have already approved the use of Seroquel (quetiapine) and drugs like it to treat schizophrenia and bipolar disorder.

Wednesday's decision, by a panel of psychiatric experts, follows a study released earlier this year that suggested that newer, second-generation antipsychotics such as Seroquel might pose heart risks -- specifically, a higher risk of sudden death due to cardiac arrest. The study was published in the Jan. 15 issue of the New England Journal of Medicine.

At the time, experts said that the overall odds of a heart problem for patients taking this class of medications -- which also includes clozapine (Clozaril), olanzapine (Zyprexa) and risperidone (Risperdal) -- were probably low, and the drugs remained appropriate for certain patients. Still, doctors, families and patients should be cautious, according to the study's lead author, Wayne Ray, director of the Vanderbilt University School of Medicine's Division of Pharmacoepidemiology.

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