"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.
I am a bit confused by this, however:
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.
There is nothing in the prescribing information that mentions the treatement of aggression in autism and, as of tonight, the prescribing information still says:
Safety and effectiveness in children have not been established.
Nor do I remember reading about the approval for autism in children when it was approved for short-term treatment of acute manic or mixed episodes of bipolar I disorder in adults.