FDA Approves First Anti-Psychotic for Kids

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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.