RISPERDAL information at risperdalautism.com

RISPERDAL^® (risperidone) and the treatment of irritability associated with autistic disorder

Welcome to the RISPERDAL Autism Web site. This section of the Web site is intended for healthcare professionals only. It contains important efficacy and safety information regarding the treatment of irritability associated with autistic disorder with RISPERDAL. This section will be your guide to provide you with information to make you more knowledgeable about prescribing RISPERDAL. Also there are useful links to professional sites that provide valuable insight and current news regarding autistic disorder.

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RISPERDAL^® (risperidone) is indicated for the treatment of irritability associated with autistic disorder in children and adolescents (aged 5-16 years), including symptoms of aggression towards others, deliberate self-injury, temper tantrums, and quickly changing moods.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL^®

WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL^® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL^®. Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL^®. Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL^® is not approved for treating these patients.

Hyperprolactinemia: As with other drugs that antagonize dopamine D₂ receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration.

Seizures: RISPERDAL^® should be used cautiously in patients with a history of seizures.

Orthostatic Hypotension: RISPERDAL^® may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL^® should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.

Potential for Cognitive and Motor Impairment: RISPERDAL^® has the potential to impair judgment, thinking, or motor skills. Caregivers and patients should use caution until they are reasonably certain that RISPERDAL^® does not affect them adversely.

Maintenance treatment: Physicians who elect to use RISPERDAL^® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

Commonly observed adverse reactions for RISPERDAL^®: The most common adverse reactions from all clinical trials (>10%) were: somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, saliva increased, constipation, fever, Parkinsonism, dystonia, abdominal pain, anxiety, nausea, dizziness, dry mouth, tremor, rash, akathisia, and dyspepsia.

Keep out of reach of Children.

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For more information, read the Important Product Information by clicking here.
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© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2006-2008.
This site is published by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and is intended for visitors from the United States of America. Last Modified On Jun 03 2008 at 20:26:56 EDT

RISPERDAL® (risperidone) and the treatment of irritability associated with autistic disorder

RISPERDAL^® (risperidone) and the treatment of irritability associated with autistic disorder