On August 22, 2007 the U.S. Food and Drug Administration (FDA) approved use of the antipsychotic drug Risperdal to treat schizophrenia and bipolar disorder in youths of various ages.

The approval comes with various usage restrictions. Risperdal may be used to treat schizophrenia in individuals ages 13-17 for short-term treatment of manic disorder. Individuals ages 10-17 can be treated for bipolar I disorder with Risperdal. Bipolar I disorder is characterized by recurrent bouts of mania and depression.

The approval marks the first FDA-approved atypical antipsychotic drug to treat the disorders in these age groups. Adults suffering from schizophrenia and bipolar disorder may already be treated with Risperdal.

Thomas Laughren, MD, director of the psychiatric products division at the FDA’s center of Drug Evaluation and Research, says that test data from the trial “suggest[s] a signal for some weight gain” in youths taking Risperdal.

In October of 2006, the National Autism Association (NAA) challenged the FDA’s approval of Risperdal to treat autistic children aged five to 16 due to potential side effects. The NAA warned parents of Risperdal’s side effects, which may include lactation in boys and girls, weight gain, and the development of tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements.

Source: “FDA OKs Risperdal for Kids and Teens”, WedMD.Com, August 22, 2007; Group urges caution on new Risperdal use,” Houston Chronicle, October 20, 2006.