FDA Approves RISPERDAL® to Treat Adolescents With Schizophrenia and Children and Adolescents With Bipolar Mania

Titusville, NJ.- The U.S. Food and Drug Administration (FDA) today 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.

Janssen is the only U.S. pharmaceutical company exclusively dedicated to mental health. For more information about RISPERDAL®, visit www.janssen.com.

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 five-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.

Important Safety Information For RISPERDAL®

Elderly 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 percent 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®, 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.

You may have heard the term “extrapyramidal symptoms” (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors and muscle stiffness. Some people taking RISPERDAL® have these side effects. If you have these symptoms, talk to your health care professional.

Some medications may interact with RISPERDAL®. Avoid alcohol while on RISPERDAL®.

Inform your health care professional if you are pregnant or if you are planning to get pregnant while taking RISPERDAL®. Do not breastfeed if you are taking RISPERDAL®.

RISPERDAL® may affect your driving ability, therefore, do not drive or operate machines before talking to your health care professional.

RISPERDAL® may affect alertness and motor skills; use caution until the effect of RISPERDAL® is known.

Please see full important U.S. prescribing information for RISPERDAL® at www.janssen.com.