October 10, 2006 -- Drug Approved to Treat Irritability in Children with Autism

The federal Food and Drug Administration announced October 6 that it has approved the adult antipsychotic drug Risperdal (risperide) in tablet form for symptomatic treatment of irritability in autistic children and adolescents. Steve Galson, director of the FDA’s Center for Drug Evaluation and Research, noted that Risperdal is “a welcome addition” to the growing number of adult drugs that have been shown to have “an appropriate risk-benefit profile” when tested in children. Risperdal has been in use since 1993 for short-term treatment of adults with schizophrenia and since 2003 for short-term treatment of adults with acute manic episodes associated with extreme mood swings. The drug was tested for safety and effectiveness in children in placebo-controlled trials involving children 5 to 12 years old, the FDA said. Risperdal is the first drug ever approved to treat behaviors generally referred to as irritability in children with autism, which may include aggression, deliberate self-injury, and temper tantrums. Risperdal is marketed by Janssen, L.P., of Titusville, NJ.