RISPERIDONE TREATMENT OF CHILDREN AND ADOLESCENTS - INCREASED RISK OF EXTRAPYRAMIDAL SIDE-EFFECTS

In open clinical trials, 10 children and adolescents (7-17 years) refractory to previous treatments were administered the atypical antipsychotic risperidone (2-6 mg daily). The sample covered a wide range of diagnostic entities, including psychosis, schizophrenia, bipolar disorder, major depression with psychotic features, Tourette's dis order, obsessive-comp ulsi ve disorder, and posttraumatic stress disorder. Risperidone studies in adults have suggested a low incidence of adverse effects, particularly extrapyramidal symptoms. However, 6 of the 10 youths developed extrapyramidal symptoms, and four required the addition of anticholinergic medication. Also, four patients developed dysphoric mood, two of whom met criteria for major depression and required the addition of an antidepressant. Three patients had a significant weight increase. One (age 17) of the 3 adolescent girls developed galactorrhea. Only two patients were free of serious adverse effects. However, all 10 showed overall clinical improvement in their target symptoms during treatment with risperidone. These preliminary and uncontrolled findings do not permit firm; inferences about the safety or efficacy of risperidone. However, the apparently high incidence of adverse effects underscores the risk of generalizing findings in adult studies to children and adolescents, and encourages caution in using newly developed pharmacological agents in the pediatric population. Special care is urged in using risperidone in youth until controlled data are available.