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FDA Panel Snubs Seroquel as 1st Choice Depression Treatment


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"If they're being used for schizophrenia, consider a cardiology evaluation. If you're considering using them for bipolar disorder, think about using another alternative drug first," Ray told HealthDay in January.

And patients should rarely, if ever, take the drugs to treat other conditions, he said. However, doctors have also prescribed them for so-called "off-label" uses to treat conditions such as anxiety, attention deficit disorder in children and dementia in the elderly.

"For schizophrenics, they work pretty well. They're pretty much the only alternative," Ray said. But other drugs offer alternatives for bipolar patients, he noted.

Text Continues Below



In their study, Ray and his colleagues expanded on earlier research that suggested the newer drugs disrupt the heart's rhythm. The team found that users of the newer drugs were 2.26 times more likely to suffer from sudden cardiac death than those not on the medications. Those who used the older drugs were 1.99 times more likely to die versus those not taking the medications.

The drugs appear to cause problems by disrupting potassium in the heart, causing its electrical rhythm to fail, Ray said.

In a statement released Wednesday, Dr. Howard Hutchinson, chief medical officer of AstraZeneca, which makes Seroquel, said the company was "pleased" that the panel found Seroquel appropriate as adjunctive therapy for depression.

Acknowledging that the panel "had concerns around the long-term safety profile in these new populations," Hutchinson said that he and his colleagues "look forward to having further discussions with the FDA" regarding the new drug applications.

In the meantime, AstraZeneca is fending off claims from thousands of former Seroquel users that the U.K.-based drug maker held back data on the drug's risks, according to the Associated Press. Seroquel's labeling now alerts users to heightened risks for high blood pressure, diabetes and death.

More information

There's more on the newer class of antipsychotic medications at the U.S. Food and Drug Administration.

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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 4/9/2009

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From Healthscout's partner site on depression, MyDepressionConnection.com
UNDERSTAND: Get a full understanding of depression
TREATMENT: Learn how therapy and lifestyle changes can help
DRUGS: Common drugs used to treat depression





SOURCES: April 8, 2009, statement, U.S. Food and Drug Administration; April 8, 2009, news release, AstraZeneca; Associated Press; Wayne Ray, Ph.D., director, Division of Pharmacoepidemiology, Vanderbilt University School of Medicine, Nashville; Jan. 15, 2009, New England Journal of Medicine


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