US FDA clears J

WASHINGTON, Oct 7 (Reuters) A schizophrenia drug won US approval as the first medicine to treat symptoms of autism in children and adolescents, the Food and Drug Administration said.

The FDA said Johnson&Johnson's Risperdal could be used to treat irritability, including aggression, deliberate self-injury and temper tantrums.

Autism is a term used to describe a broad range of symptoms, from repetitive behaviors to trouble with language and sometimes mental retardation.

Risperdal is already Johnson&Johnson's biggest-selling product, with 2005 global sales of about 3.5 billion dollars.

The FDA said it based the new approval on two eight-week studies in 156 autistic patients ages 5 to 16 who took Risperdal or a placebo. Ninety-per cent of them were between the ages of 5 to 12.

Patients treated with Risperdal had improved scores on two scales measuring behavioral symptoms, the FDA said.

The Centers for Disease Control and Prevention estimated in May that autism affected up to one in every 175 children. That would mean at least 300,000 US school children have autism.

Johnson&Johnson said Risperdal does not treat core autism symptoms such as communication problems and trouble with social interactions, but ''it has been shown to be beneficial in treating the associated behavioral disturbances that can interfere with school, learning and family life.'' Risperdal, an oral drug, has been sold since 1993 for the short-term treatment of adults with schizophrenia. It was approved in 2003 for short-term treatment of adults with bipolar mania. The most common side effects include drowsiness, constipation, fatigue and weight gain.

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