The National Autism Association (NAA) is challenging the Food and Drug Administration’s (FDA) approval of Risperdal as a treatment for autistic children because of the potential side effects of the drug.

Risperdal, made by Johnson & Johnson subsidiary Jannsen, has been on the market since 1993 to treat schizophrenia and bipolar disorder in adults, and was expanded in October 2006 to treat irritability associated with autism in children.

The NAA is urging parents to carefully research the drug and its side effects, which may include lactation in boys and girls, weight gain and the development of tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements.

Johnson & Johnson has stated that the drug was given expanded approval only to treat the irritability symptoms of autism in children.

Sources: “Group urges caution on new Risperdal use,” Houston Chronicle, October 20, 2006; Food and Drug Administration patient information sheet.