WebMD Health News
Louise Chang, MD
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.Ã 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.
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
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.
SOURCES: News release, FDA. National Institute on Mental Health:
"Bipolar Disorder." Thomas Laughren, MD, director, Division of
Psychiatry Products, Center for Drug Evaluation and Research, FDA. WebMD
Medical News: "FDA OKs Drug for Autism Irritability."
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