FDA Approves Pediatric Use of Risperdal
Byline: Stephen Barlas
The clinical trials that were the basis for the FDA's approval of risperidone (Risperdal) for treatment in adolescents aged 13 to 17 years who are suffering from schizophrenia and for short-term treatment of bipolar mania in children aged 10 to17 years give psychiatrists some valuable new information about use of the drug, which physicians have been prescribing off-label for some time. Those trials also underscore at least 1 potential red flag that has been raised about the Janssen product.
The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.
The 2 new indications were approved on the...