ROCKVILLE, Md. -- The FDA approved risperidone (Risperdal) today for schizophrenia in adolescents and for bipolar I disorder in pediatric patients as young as 10.
ROCKVILLE, Md., Aug. 22 -- The FDA approved risperidone (Risperdal) today for schizophrenia in adolescents and for bipolar I disorder in pediatric patients as young as 10.
The action marks the first time that the FDA has approved an atypical antipsychotic medication for use in children, said Thomas Laughren, M.D., director of the division of psychiatry products at the FDA's Center for Drug Evaluation and Research.
At a press briefing Dr. Laughren said the FDA was aware that risperidone was already used off-label to treat both conditions in children. Yet, he pointed out that the three trials submitted for approval provided evidence that risperidone is effective in children at doses of 1 to 3 mg and increasing the dose to 3 to 6 mg did not increase efficacy.
The indication for schizophrenia is for treatment in adolescents ages 13 to 17 and the bipolar approval is for ages 10 to 17.
Dr. Laughren said the FDA action on risperidone marks the first formal approval of a schizophrenia drug for children. He cited "vague wording" on the labels of older antipyschotics such as haloperidol (Haldol) and chlorpromazine (Thorazine) that the drugs may be useful in treating schizophrenia in children.
Lithium is approved for bipolar disorder for children age 10 or older.
Dianne Murphy, M.D., director of the FDA's office of pediatric therapeutics, said that although these conditions are relatively uncommon in children, when they occur they are "devastating to families and children." That devastation, she said, "is a public health concern."
As in adults, risperidone was associated with weight gain in children and it also increased prolactin levels by about 49%, which makes gynecomastia a consideration said Dr. Laughren.
Although weight gain was reported in the trials, there was no evidence of an increase in serum glucose, but Dr. Laughren said that all trials were short term, which could explain that finding.
Risperidone was approved earlier this year for treatment of irritability associated with autism. As part of that approval, the FDA requested long term follow-up studies and Dr. Laughren said the data from those post-marketing studies should elucidate the diabetes risk.
The FDA granted the new indications on the basis of results of two schizophrenia studies that enrolled a total of 255 adolescents and one bipolar trial that enrolled 109 patients. In each trial half of the participants received risperidone and half placebo.
The schizophrenia trials evaluated six to eight weeks of treatment and the bipolar trial investigated three weeks of treatment.
All participants in the schizophrenia trial were experiencing an acute episode at the time of enrollment. The FDA said treated patients had a decrease in hallucinations, delusional thinking, and other symptoms.
Patients in the bipolar trial were experiencing a mixed or manic episode at enrollment. After treatment, patients had a decrease in elevated mood and hyperactivity and a decrease in other symptoms.