Atypical antipsychotic approved for use in children

August 24, 2007

Risperidone has been approved by the FDA for use in children and adolescents aged 10 to 17.

Risperidone (Risperdal, Janssen) has been approved by the FDA for use in children and adolescents aged 10 to 17 for the short-term treatment of manic or mixed episodes of bipolar I disorder and for the treatment of schizophrenia in adolescents 13 to 17 years old. According to the manufacturer, this is the first time an atypical antipsychotic drug has been approved for use in children for either disorder. The approval was based on the results of two short-term trials and one three-week study for schizophrenia and bipolar disorder, respectively. Risperidone was previously approved for these two indications in adults and for the treatment of irritability associated with autistic disorder in children and adolescents five to 16 years old. The American Psychiatric Association supports the new approvals, calling them a result of the Best Pharmaceuticals for Children Act, which was designed to encourage pediatric drug research.

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