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Risperdal Gets FDA’s Approval for Children and Teens

By Senior News Editor
Reviewed by John M. Grohol, Psy.D. on August 27, 2007

pillsOn Wednesday, the U.S. Food and Drug Administration (FDA) approved the antipsychotic drug Risperdal to treat schizophrenia and bipolar disorder in children ages 13 to 17.

The FDA approved Risperdal to be used to treat schizophrenia in adolescents aged 13-17 and for the short-term treatment of manic or mixed episodes of the most common form of bipolar disorder in children and adolescents aged 10-17.

Risperdal is the first FDA-approved atypical antipsychotic drug to treat either disorder in these age groups. Atypical antipsychotic drugs are a type of 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 has commonly been prescribed “off-label” by doctors for treatment of bipolar disorder and schizophrenia in children for years. The FDA approval legitimizes these prescriptions, and opens the door for the maker of Risperdal, Janssen, to advertise the drug for these uses. Risperdal goes off-patent for adult prescriptions next year.

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 is commonly prescribed for months at a time, and for some patients, years.

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.

The FDA will do an additional safety review of Risperdal’s pediatric use over the next year.

 

APA Reference
Nauert, R. (2007). Risperdal Gets FDA’s Approval for Children and Teens. Psych Central. Retrieved on October 25, 2014, from http://psychcentral.com/news/2007/08/24/risperdal-gets-fdas-approval-for-children-and-teens/1185.html