FDA Approves First Anti-Psychotic for Kids

Risperdal had been used off-label to treat children with schizophrenia, bipolar disorder.

By Steven Reinberg
HealthDay Reporter
Thursday, August 23, 2007; 12:00 AM

Copyright © 2007 ScoutNews, LLC. All rights reserved.

WEDNESDAY, Aug. 22 (HealthDay News) -- The powerful anti-psychotic drug Risperdal was approved by the U.S. Food and Drug Administration on Wednesday for use in children and adolescents who have schizophrenia or bipolar disorder.

Until this point, the agency hadn't approved any drug for the treatment of adolescent schizophrenia. For bipolar disorder, only lithium is approved for use in adolescents aged 12 and older.

"The FDA has approved Risperdal for treating schizophrenia in adolescents 13 to 17 and for the short-term [three-week] treatment of bipolar I disorder in children and adolescents 10 to 17," Dr. Thomas Laughren, director of the Division of Psychiatry Products at the agency's Center for Drug Evaluation and Research, said during a midday teleconference.

One expert thinks the move is warranted.

"This is a drug that has real value," said Dr. Charles Goodstein, a clinical professor of psychiatry at New York University Medical School. "But one has to exercise a degree of caution when using what amount to be heavy-duty medications in young children and adolescents."

Goodstein noted that diagnosing children with these conditions is difficult, and that can lead to misdiagnosis and the prescribing of inappropriate medications. "One has to very careful that this medication is not overused," he said.

"Bottom line, it's a valuable medication, one that can produce momentous changes in a person's functioning, but a medication that should be used with great care, because it does have side effects, and too often diagnoses are made more readily than they should be made," Goodstein said.

The agency first approved Risperdal (risperidone) in 1993 for treating schizophrenia in adults. It was approved subsequently for the short-term treatment of acute manic or mixed episodes of bipolar I disorder in adults and the treatment of irritability associated autism in children and adolescents aged 5 to 16, Laughren noted.

Risperdal brought in $2.3 billion in sales in 2005, according to the Associated Press.