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August 22, 2007

Risperdal Approved by FDA for Treatment of Bipolar Disorder 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 Bipolar Disorder. Many psychiatrists already prescribe the drug to children and teens, but now the FDA has approved its safety and use based on further research.

Now that its officially approved, 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.

Doctors have, in many cases, been using Risperdal and other antipsychotic medicines to treat bipolar disorder, but the drug agency’s stamp of approval will allow Johnson & Johnson to promote the drug for short-term treatment of bipolar episodes in ages 10 to 17.

"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."

However, The Wall Street Journal reported today that there are still many concerns about the long term impact of giving medications to children:

"Some doctors are concerned about the safety of treating children whose bodies are still growing with Risperdal and similar medications. They point out that the FDA's decision is based on short-term studies. Risperdal and competing drugs have previously been tied to serious side effects including increased blood sugar, a potential precursor to diabetes.

"We definitely need to have longer-term followup data to learn the full extent of the side-effect liabilities," said Jeffrey Lieberman, chairman of the psychiatry department at Columbia University in New York. His department gets research funding from drug companies."

There are still side effects and dangers 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."

To reduce the risk of side effects patients on Risperdal should have their diet and weight gain closely monitored and have their dosage or medication adjusted if needed.

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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