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FDA Panel Snubs Seroquel as 1st Choice Depression Treatment
Date:4/8/2009

ing to the study's lead author, Wayne Ray, director of the Vanderbilt University School of Medicine's Division of Pharmacoepidemiology.

"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.

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
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