May 2005

From: Janssen Pharmaceutica Inc.

Important Drug Warning

Janssen Pharmaceutica Products, L.P. (Janssen) and all manufacturers of atypical antipsychotics have been requested by the Food and Drug Administration (FDA) to add important safety information regarding the use of atypical antipsychotics in elderly patients with dementia-related psychosis to their U.S. prescribing information. Based on a meta-analysis of 17 placebo-controlled trials of atypical antipsychotics in elderly patients with dementia, the FDA has determined that there is increased mortality in drug-treated patients compared to placebo-treated patients. This finding was seen in all three chemical classes of atypical antipsychotics. Therefore, FDA concluded that this finding was probably related to the common pharmacological effects of all atypical antipsychotics in these classes, including Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), RISPERDAL (risperidone), Clozaril (clozaoine), and Geodon (ziprasidone), as well as the combination product Symbyax (olanzapine and fluoxetine). None of the antipsychotics is approved for the treatment of behavioral disorders in elderly patients with dementia.

Accordingly, the prescribing information for RISPERDAL (risperidone) and RISPERDAL CONSTA (risperidone) LONG-ACTING INJECTION have been updated as follows:

1. At the beginning of the prescribing information the following Boxed Warning has been added:

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 compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-teated 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. RISPERDAL (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

2. The following information has been added to the beginning of the WARNINGS section of the prescribing information.

WARNINGS

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 compared to placebo. RISPERDAL (riperidone) is not approved for the treatment of patients with dementia-related psychosis (see Boxed Warning).

Janssen remains committed to providing you with the most current prescribing information for all of our products to help in the management of your patients. Patients receiving atypical antipsychotics for treatment of behavioral disorders associated with dementia should have their treatment reviewed by their healthcare providers. Please refer the enclosed package inserts for RISPERDAL and RISPERDAL CONSTA for the updated full prescribing information. For more information on the FDA request to all manufacturers of atypical antipsychotics, lease read the enclosed FDA Public Health Advisory. As always, we request that serious adverse events be reported to Janssen at 1-800-JANSSEN (800-526-7736), or to the FDA MedWatch program by phone (1-800-FDA-0178), or on line (www.fda.gov/medwatch).

For additional information about RISPERDAL, RISPERDAL CONSTA, or any other Janssen product, please call 1-800-JANSSEN (800-526-7736) from 9AM to 5PM EST, Monday through Friday.

Sincerely,

Ramy Mahmoud, MD,MPH

Vice President, Medical Affairs