FDA Approves Antipsychotic Drug for Irritability in Autistic Children

ROCKVILLE, Md., Oct. 9 -- The FDA has approved Risperdal (risperidone), an adult antipsychotic agent, for symptomatic treatment of irritability in autistic children and adolescents.

Risperdal, marketed by Janssen, is the first drug approved for this indication. Aggression, deliberate self-injury, and temper tantrums were the behaviors identified for Risperdal treatment.

Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, characterized the approval is part of an FDA initiative to encourage the "development of appropriate pediatric labeling for adult drugs," once the drugs have demonstrated an appropriate risk-benefit profile when tested in children.

Risperdal has been approved since 1993 for the short-term treatment of adults with schizophrenia, and since 2003 for the short-term treatment of adults with acute manic or mixed episodes associated with extreme mood swings.

The product's effectiveness in the symptomatic treatment of irritability associated with pediatric autistic disorders was established in two eight-week, placebo-controlled trials in 156 patients ages five to 16, 90% of them five to 12.

The results, which were evaluated using two assessment scales, showed that children taking Risperdal achieved significantly improved scores for certain behavioral symptoms of autism compared with children on placebo. The most common side effects of the use of Risperdal included drowsiness, constipation, fatigue, and weight gain.