The FDA has approved Risperdal to treat irritability in children and adolescents with autism.

It’s the first approval of a drug for use in treating behavior-related problems associated with autism in children. Classified under the general heading of irritability, these behaviors include aggression, deliberate self-injury, and temper tantrums.

“This approval should benefit many autistic children as well as their parents and other care givers,” says Steven Galson, MD, director of FDA’s Center for Drug Evaluation and Research, in a news release.

Risperdal is an antipsychotic drug that has been approved for use in treating adults with schizophrenia since 1993; it has been approved since 2003 for the short-term treatment of adults with acute manic episodes or episodes with extreme mood swings.

The approval for treating children with autism was based on two eight-week clinical trials that evaluated the drug vs. placebo in 156 children 5 to 16 years old. The results showed that children on Risperdal significantly improved in measures of irritability associated with autism compared with children who received the placebo.

The most common side effects of Risperdal were drowsiness, constipation, fatigue, and weight gain.

Risperdal is manufactured by Janssen Pharmaceutica N.V. in Beerse, Belgium.

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SOURCE: News release, FDA.