FDA Approves Antipsychotic Risperdal For Use In Some Children

FDA on Wednesday approved the atypical antipsychotic Risperdal, manufactured by Johnson & Johnson subsidiary Janssen, for use in children with schizophrenia and bipolar disorder, the Wall Street Journal reports. The move marks the first time that FDA has approved an atypical antipsychotic for use in children with schizophrenia and bipolar disorder (Mathews/Johnson, Wall Street Journal, 8/23). FDA previously has approved Risperdal, which first reached the U.S. market in 1993, for use in adults with schizophrenia and bipolar disorder and for use children ages five to 16 with irritability associated with autism.

Under the expanded approval, J&J can market Risperdal for use in children ages 13 to 17 with schizophrenia and for short-term use in children ages 10 to 17 with bipolar disorder. FDA said that about 0.1% to 1% of reported schizophrenia cases involve children ages 13 to 17 (Reuters/New York Times, 8/23). The approval likely will prompt physicians to prescribe and health insurers to cover Risperdal over rival medications that have not received FDA approval for those uses.

Clinical Trials
FDA decided to expand approval for Risperdal based on the results of three clinical trials conducted by Janssen. In the trials, which involved almost 600 children, about 8% of participants who took Risperdal experienced weight gain of about four kilograms that ended after three or four months. More than half of trial participants who took Risperdal experienced an increase in prolactin, a hormone linked with lactation, and 1.5% developed breast milk (Wall Street Journal, 8/23).

Other side effects experienced by trial participants who took Risperdal included drowsiness, fatigue, increased appetite, anxiety, nausea, dizziness, dry mouth, tremor and rash (Reuters/New York Times, 8/23). The trials lasted three, six and eight weeks. J&J plans to conduct longer-term trials in the future (Wall Street Journal, 8/23).

Implications
According to the Boston Globe, the expanded approval for Risperdal likely will "stoke an already fierce debate about how frequently such drugs should be prescribed." Some experts maintain that physicians have overprescibed such medications, in part because of marketing campaigns conducted by pharmaceutical companies that manufacture them (Henderson, Boston Globe, 8/23).

According to a study published last year in the Archives of General Psychiatry, physician visits by patients ages 20 and younger that resulted prescriptions for antipsychotics, most of which involved atypical antipsychotics, increased to 1.2 million in 2002 from about 201,000 in 1993. In addition, reports have linked Risperdal and other atypical antipsychotics with serious side effects, and some experts have raised concerns about the safety of their use in children, whose bodies have not fully developed.

However, according to some experts, the potential benefits of Risperdal and other atypical antipsychotics in children with schizophrenia and bipolar disorder can outweigh the risks. Other experts cited the need for longer-term studies of the safety of Risperdal and other atypical antipsychotics in children (Wall Street Journal, 8/23).

Broadcast Coverage

NPR's "Morning Edition" on Thursday included a discussion with Carolyn Robinowitz, president of the American Psychiatric Association, about the expanded approval for Risperdal (Montagne, "Morning Edition," NPR, 8/23). Audio of the segment is available online.

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View drug information on Risperdal Oral Formulation.