• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Risperdal (risperidone) Dear Healthcare Professional Letter Apr 2003

 

This is the text of a letter from Janssen Pharmaceutica Inc. Contact the company for a copy of any referenced enclosures.

 


 

JANSSEN PHARMACEUTICA INC.

IMPORTANT DRUG INFORMATION

16-April-2003

Dear Healthcare Provider,

Janssen Pharmaceutica Products, L.P., would like to inform you of important changes regarding RISPERDAL (risperidone). The RISPERDAL prescribing information has been updated with the addition of the following information:

WARNINGS
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia
Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years; range 73-97) in trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis.

This update is based on data from 4 placebo-controlled trials conducted in elderly patients with dementia (N=1230). Additional information on these and other clinical trials conducted in elderly patients can be obtained by calling 1-800-JANSSEN (800-526-7736). We remind you that, like all other antipsychotics, RISPERDAL is not indicated for the treatment of dementia.

Janssen Pharmaceutica Products, L.P., remains committed to providing you with the most current product information available for the management of your patients. Please refer to the enclosed package insert for full prescribing information. As always, we request that serious adverse events be reported to Janssen at 1-800-JANSSEN (526-7736) or to the FDA MedWatch program by phone 1-800-FDA-1088, by fax
(1-800-FDA-0178), or by email (www.fda.gov/medwatch). For additional medical information about RISPERDAL or any other Janssen product, please call 1-800-JANSSEN (526-7736) from 9AM to 5PM EST, Monday through Friday.

Sincerely,

Christine Cote, MD
Vice President, Medical Affairs
Janssen Pharmaceutica Inc.

 

1125 TRENTON-HARBOURTON ROAD
POST OFFICE BOX 200
TITUSVILLE, NEW JERSEY 08560-0200
(609) 730-2000
US.JANSSEN.COM