FDA News

FDA Approves RISPERDAL to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania

(Aug 23, 2007)-- The U.S. Food and Drug Administration (FDA) approved RISPERDAL (risperidone) for the treatment of schizophrenia in adolescents ages 13-17 and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents ages 10-17.

This approval is based on studies involving more than 430 adolescents, ages 13-17, in the treatment of schizophrenia and 160 children and adolescents, ages 10-17, for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder.

RISPERDAL is marketed in the U.S. by Janssen, L.P. and promoted by McNeil Pediatrics, a division of McNeil-PPC., Inc. RISPERDAL (risperidone) is indicated in adults for the treatment of schizophrenia, for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder, for the treatment of irritability associated with autistic disorder in ages 5-16 years, for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 10-17 years.

IElderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

The most common adverse reactions observed in all clinical trials with Risperdal occurring at a rate of at least 10% were: somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, saliva increased, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.

A rare but serious side effect that has been reported with this kind of medicine, including RISPERDAL(R), is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.

You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your health care professional.

Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including RISPERDAL. Some people may need regular blood sugar testing.

Some people taking RISPERDAL may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your health care professional's dosing instructions, this side effect may be reduced or it may go away over time.

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