August 22, 2007

Risperdal Approved by FDA for Treatment of Schizophrenia In Children and Teens

A few months ago we featured a news story that Risperdal was in the process of being approved by the FDA for use in children and adolescents for treatment of Schizophrenia. Many psychiatrists already prescribe the drug to children and teens, but now the FDA has approved its safety and use based on further research.

The research that lead to the approval may have strengthened the efficacy and safety of Risperdal's use in children and teens. Until now, physicians have not had a lot of guidance in prescribing the drug to these younger populations.

"The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population," said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. "These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients."

There are still side effects associated with its use - as has been known with adult use. "Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported."

Risperdal is manufactured by Janssen, L.P. of Titusville, N.J

Read Full FDA Press Release:
FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents


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