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FDA Panel Mulls Newer Antipsychotics for Kids
Date:6/10/2009

Seroquel, Zyprexa have been linked to certain health risks, experts note,,

WEDNESDAY, June 10 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel is expected to vote Wednesday on whether several powerful but controversial antipsychotic drugs be approved for use by children.

The drugs in question include new-generation "atypical" antipsychotics such as Geodon, Seroquel, and Zyprexa, currently approved for adult use. The medications are also being prescribed "off-label" by many doctors to treat schizophrenia and bipolar disorder in children ages 10 to 17, despite possible serious side effects, including diabetes and heart woes.

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."

Fortunately, treatment is available to help children and adolescents who suffer from schizophrenia and bipolar disorder, including the medications being considered by the FDA panel, Fassler added.

Drug maker AstraZeneca is asking the FDA to let it market Seroquel to adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pharmaceutical giant Lilly is asking for the same permission for its drug, Zyprexa. In addition, drug maker Pfizer wants approval to market a third atypical antipsychotic, Geodon, used to treat bipolar disorder, to patients 10 to 17.

And yet safety concerns plague many of these drugs. In 2004, the FDA ordere
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