FDA Panel OKs Antipsychotic Seroquel for Children

June 10 -- 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, older patients with dementia-related psychosis treated with Seroquel are at an increased risk of death, according to the FDA.

And in a unanimous vote in early April, an FDA advisory panel determined that Seroquel should not be approved as first-line therapy for adult depression, because of continued questions about its safety profile -- most notably, a link to higher risk for sudden cardiac death. However, the drug was approved for use in patients for whom other antidepressants didn't work.