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Medical News & Perspectives
August 26, 2009

FDA Panel OKs 3 Antipsychotic Drugs for Pediatric Use, Cautions Against Overuse

JAMA. 2009;302(8):833-834. doi:10.1001/jama.2009.1152

Despite safety concerns, a US Food and Drug Administration (FDA) advisory panel recommended in June that the agency approve 3 atypical antipsychotic drugs for the treatment of children and adolescents with bipolar disorder or schizophrenia. The drugs are associated with substantial weight gain and metabolic problems.

Two atypical antipsychotic drugs, risperidone and aripiprazole, are currently approved for the treatment of these conditions in pediatric patients. But the FDA asked its advisors to consider whether there is sufficient evidence to support approval of 3 similar drugs for use in younger patients. These drugs—quetiapine, ziprasidone, and olanzapine—are currently approved for treating schizophrenia or bipolar disorder in adults and are used widely off label in children.

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