The FDA ( Food and Drug Administration ) has approved Risperdal ( Risperidone ) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of irritability in autistic children and adolescents. The approval is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors are included under the general heading of irritability, and include aggression, deliberate self-injury, and temper tantrums.

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 8-week, placebo-controlled trials in 156 patients aged 5 to 16 years, 90 percent of whom were 5-12 years old.
The results showed that children on Risperidone achieved significantly improved scores for certain behavioral symptoms of autism compared to children on placebo.

The most common side effects of Risperidone included drowsiness, constipation, fatigue and weight gain.

Source: FDA, 2006


XagenaMedicine2006