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FDA Panel OKs Antipsychotic Seroquel for Children
Date:6/10/2009

The drug, and others like it, have been linked to certain health risks, experts note,,

WEDNESDAY, June 10 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Wednesday voted "overwhelmingly" that Seroquel, a powerful antipsychotic drug, be approved to treat schizophrenia in children.

A ruling on Seroquel's use for children with bipolar disorder is also expected Wednesday, as are similar decisions for the antipsychotics Geodon and Zyprexa, the Associated Press reported.

All three are part of the new-generation "atypical" antipsychotics, currently approved for adult use. The medications have been prescribed "off-label" by many doctors for years to treat schizophrenia and bipolar disorder in children ages 10 to 17, despite possible serious side effects, including diabetes and heart woes.

Seroquel is made by drug maker AstraZeneca. Pharmaceutical giant Lilly is seeking the same approvals for Zyprexa. And drug maker Pfizer wants approval to market Geodon to treat bipolar disorder in patients 10 to 17 years old.

There is a pressing need for effective antipsychotics for children, one expert noted.

"Schizophrenia and bipolar disorder are very real illnesses, which collectively affect between 1 percent and 3 percent of all young people," noted Dr. David Fassler, a clinical professor of psychiatry at the University of Vermont College of Medicine, who testified before the panel Tuesday. "Without treatment, children have problems at school, at home, and with their friends. They're also at increased risk of accidents, hospitalization, and death at an early age from multiple causes, including suicide."

And yet safety concerns plague many of these drugs. In 2004, the FDA ordered AstraZeneca to add a special "black box" warning to Seroquel's packaging, outlining increased risks of hyperglycemia, high blood pressure and diabetes associated with use of the drug. Also,
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FDA Panel OKs Antipsychotic Seroquel for Children
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