'Risperdal' Cleared By FDA To Treat Autistic Children

by Medindia Content Team on  October 7, 2006 at 6:24 PM Drug News
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'Risperdal' Cleared By FDA To Treat Autistic Children
'Risperdal' (Risperidone) an antipsychotic drug has been for the first time given the green signal to be implemented for symptomatic treatment of emotional disturbances in children and teenagers suffering from Autism, by The U.S. Food and Drug Administration.

An antipsychotic drug generally employed in the treatment of adults, Risperidone will thus become the first one in its league to be used in treating children affected with Autism.

Risperdal was first approved and implemented in the short-term treatment of Schizophrenia in adults way back in 1993. In 2003 it was cleared for short term treatment of mania and mixed outbreaks of extreme mood swings as well.. Now the FDA has cleared this drug to be safely implemented in the treatment of behavior disorders in autistic children that suggest irritability, which includes temper tantrums, attempted self-mutilation, and aggression.

Its compatibility to treat irritability and aggression in children was proved in a series of tests conducted in two 8-week, placebo-controlled trials done amongst 156 patients between ages 5-16. The results of the battery of tests showed remarkable improvement in symptoms associated with irritability in autistic children given Risperidone as opposed to those given placebo who showed no improvement. Common side effects encountered with the use of this drug are drowsiness, tiredness, constipation and weight gain.

Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research was hopeful that this drug would be of great benefit for many autistic children. He also emphasized that the agency he represents firmly believes in encouraging development of apt drugs that can be employed in treating children, which were hitherto used among adults.

Source: Eurekalert
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