A Johnson & Johnson drug received expanded U.S. government approval Friday to treat aggression and other symptoms of autism in children.
The new use for Risperdal is to treat irritability associated with autistic disorder, including temper tantrums, deliberate self injury and aggression in children and adolescents, ages 5 to 16.
The approval is the first for the use of a drug to treat behaviors associated with autism in children, the Food and Drug Administration said.
Risperdal, first approved by the FDA in 1993, has been used to treat schizophrenia and bipolar disorder in adults.
The anti-psychotic drug is not a cure for autism, nor does it treat the condition itself, but may provide relief for some children, according to Johnson & Johnson.
Autism is a complex developmental disability. It typically appears during a child's first three years of life, and affects communication, social interaction and creative or imaginative play.
"This approval should benefit many autistic children as well as their parents and other caregivers," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Two eight-week trials involving 156 children between the ages of 5 and 16 showed that those given Risperdal achieved significantly improved scores for certain behavioral symptoms of autism compared to those given dummy pills, the FDA said.
In 2005, the FDA declined to expand its approval of Risperdal, also known as risperidone, to include autism.
The most common side effects of Risperdal include drowsiness, constipation, fatigue and weight gain.
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