August 23, 2007 A statement issued August 22 by the U.S. Food and Drug Administration (FDA) notes that the FDA has approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar 1 disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups. Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents age 12 and up. The statement points out that evidence to support the new recommendations was collected through studies requested by the FDA as part of its pediatric drug development initiatives. "Schizophrenia is a serious and disabling psychiatric disorder," the statement says. "Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function." Risperdal is manufactured by Janssen, L.P. of Titusville, New Jersey. |
