The Food and Drug Administration today approved a drug for the treatment of two psychiatric conditions in teenagers and for the short-term treatment of manic depression in children.
The FDA approved Risperdal, manufactured by Janssen, L.P. of Titusville, N.J., for the treatment of schizophrenia in adolescents ages 13 to 17 and for the short-term treatment of bipolar disorder in ages 10 to 17.
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 ages 12 and up.
Safety concerns include significant weight gain in children taking Risperdal.
“There are some risks in taking these medications, there’s no question about that, but schizophrenia is a very serious disorder, and it has to be treated, ” said Thomas Laughren, director of the Division of Psychiatry Products at the FDA.
Schizophrenia is a serious and disabling psychiatric disorder. 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.
The FDA approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of manic depression in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.
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