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FDA Approves First Anti-Psychotic for Kids
Date:8/22/2007

ts 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 a those potential problems.

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.

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