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Sep 22

Schizophrenia drug given a nod for the cure of Autism

The Food and Drug Administration said on Friday that a schizophrenia drug has been okayed by U.S. as the first drug to treat the symptoms of autism in children and adolescents.

Autism is a neurodevelopmental disorder that manifests itself in markedly abnormal social interaction, communication ability, patterns of interests, and patterns of behavior.

Johnson & Johnson's Risperdal can be used to treat the behavioral disorders in Autism which includes irritability, aggression, deliberate self-injury and temper tantrums.

Other behavioral abnormalities that may be present are- staring at hands or flapping arms and hands, walking on tiptoe, strange postures, unpredictable behavior and hyperactivity.

"This approval should benefit many autistic children as well as their parents and other care givers," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

"Our agency strongly encourages the development of appropriate pediatric labeling for adult drugs, and Risperdal is a welcome addition to the growing number of such products that have been shown to have an appropriate risk-benefit profile when tested in children." said Galson.

Approved in 1993, Risperdal is an atypical antipsychotic medication and is most often used to treat delusional psychosis (including schizophrenia), but like other atypical antipsychotics, it is also used to treat some forms of bipolar disorder, psychotic depression and Tourette syndrome.

Generally lower doses are used for autistic spectrum disorders than are used for schizophrenia and other forms of psychosis.

Risperido is now the most commonly prescribed antipsychotic medication in the U.S., with global sales of about $3.5 billion.

FDA said that the approval is based on two eight week studies conducted on 156 autistic patients aged between 5 to 16 years who took Risperdal or a Placebo. It was noted that the patients who were taking Risperdal had considerably better condition than those who were taking Placebo.

Johnson & Johnson said Risperdal does not help to cure the core symptoms of Autism like communication problems and trouble with social interactions, but "it has been shown to be beneficial in treating the associated behavioural disturbances that can interfere with school, learning and family life."

The oral drug does not come without side effects which include nausea, anxiety, dizziness, insomnia, low blood pressure, muscle stiffness, muscle pain, sedation, tremors, increased salivation and weight gain.

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