FDA OKs Drug for Autism Irritability
Risperdal Approved to Treat Irritability Related to Autism in Children
Oct. 10, 2006 -- 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,