FDA Approves Drug for Psychiatric Conditions in Children, Adolescents
August 23, 2007
FDA Approves Drug for Psychiatric Conditions in Children, Adolescents
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.