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FDA Approves First Anti-Psychotic for Kids

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

WEDNESDAY, Aug. 22, 2007 (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.

Laughren said the medication belongs to a class of powerful drugs that do have side effects, but they are used to treat disabling conditions that fail to respond to other medications.

"Both of these disorders are commonly treated off-label in pediatric patients with Risperdal and other drugs that are approved for treating these conditions in adults," Laughren said.

The FDA based its approval for using the drug with schizophrenic adolescents on the results of two short-term trials. Patients taking the drug had fewer symptoms, including fewer hallucinations and less delusional thinking.

In terms of bipolar disorder, the agency relied on the outcome of a three-week trial among children and adolescents with bipolar I disorder. In this trial, patients taking Risperdal had fewer symptoms, including a reduction in elevated mood and hyperactivity, the agency noted.

Common side effects of Risperdal include drowsiness, fatigue, increased appetite, anxiety, nausea, dizziness, dry mouth, tremor and rash. "This adverse event profile is similar to what we have seen in adults who are treated with these medications," Laughren said.

However, Laughren noted Risperdal might also affect growth and development in adolescents, so the FDA has asked the drug's maker, Janssen, L.P., of Titusville, N.J., to begin a study to look at those potential problems.

Meanwhile, the American Psychiatric Association (APA) applauded the approval.

"For any medication, there are benefits and potential risks," Dr. Darrel Regier, director of the APA's Division of Research and executive director of the American Psychiatric Institute for Research and Education, said in a statement. "For many children with these disorders, the FDA's action today provides additional information to guide treatment options in these special populations. We anticipate that approval of this medication will encourage federal research agencies to accelerate urgently needed studies of mental disorders in children."

Schizophrenia is a disabling psychiatric disorder with symptoms that can include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, causes shifts in mood, energy and ability to function.

More information

For more information on Risperdal, visit the U.S. Food and Drug Administration.

SOURCES: Aug. 22, 2007, teleconference with Thomas Laughren, M.D., director, Division of Psychiatry Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Charles Goodstein, M.D., clinical professor, psychiatry, New York University Medical School, New York City, and psychiatrist, Tenafly, N.J.
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