FDA OKs Risperdal for Kids and Teens

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Updated: 9/03 11:40 am

Aug. 22, 2007 -- The FDA today approved the antipsychotic drug Risperdal to treat schizophrenia in teens and bipolar disorder in some youths.

Specifically, Risperdal may be used to treat schizophrenia in adolescents aged 13-17 and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents aged 10-17. "Bipolar disorder I" refers to recurrent episodes of mania and depression.

Risperdal is the first FDA-approved atypical antipsychotic drug to treat either disorder in these age groups. Atypical antipsychotic drugs are newer antipsychotic drugs.

Risperdal is already approved for the treatment of schizophrenia and bipolar disorder in adults, and for irritability associated with autism in kids and teens aged 5-16.

Risperdal's Pediatric Use

The FDA asked Risperdal's maker, the drug company Janssen, to study Risperdal's use in kids and teens with schizophrenia and bipolar disorder.

The FDA made that request because those conditions are "commonly" treated with Risperdal or similar drugs in kids, even though that was an off-label use of those drugs, says Thomas Laughren, MD, who directs the psychiatric products division at the FDA's Center for Drug Evaluation and Research.

Risperdal's efficacy at treating schizophrenia in teens was studied in two trials, each lasting six to eight weeks. Patients either took Risperdal or a placebo without knowing which they were taking.

Patients taking Rispderal generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other schizophrenia symptoms, according to the FDA.

Risperdal's efficacy at treating manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week trial. Patients who were experiencing a manic or mixed episode either took Risperdal or a placebo without knowing which they were taking.

Patients taking Risperdal generally had fewer symptoms of their bipolar disorder, including an easing of their elevated mood and hyperactivity.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported in Risperdal's pediatric trials.

Laughren notes that data "suggest a signal for some weight gain" in youths taking Risperdal. Janssen is already studying that possibility in a lengthier study. The FDA will do an additional safety review of Risperdal's pediatric use over the next year.

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