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Archived – Updated Safety Information for Risperdal (Risperidone) in Elderly Dementia Patients, Announced in Canada by Janssen-Ortho Inc. – For the Public

Starting date:
October 17, 2002
Posting date:
October 17, 2002
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-1900030

This is duplicated text of a letter from Janssen-Ortho Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

[Text of letter begins]

IMPORTANT DRUG SAFETY UPDATE FOR CONSUMERS

Updated Safety Information for Risperdal* (Risperidone) in Elderly Dementia Patients, Announced in Canada

Toronto, October 17, 2002 - Further to discussions with Health Canada, Janssen-Ortho Inc. advised healthcare professionals of new safety information for the use of RISPERDAL (risperidone), an antipsychotic medication in elderly, dementia patients. The manufacturer has notified doctors and pharmacists of reports of strokes and stroke-like events in clinical studies in elderly patients with dementia taking RISPERDAL.

Data were analyzed from four clinical studies in elderly, dementia patients. In two of these studies, a higher proportion of patients taking RISPERDAL experienced strokes or related events than did those who received placebo (sugar pill). Further information from ongoing analyses of clinical studies will be posted as it becomes available.

Worldwide exposure to RISPERDAL in elderly, dementia patients is approximately 2.5 million patient years. From this patient population, there have been 37 reports of strokes or stroke-like events (1 in Canada), including 16 deaths (1 in Canada). Generally, there is an increased risk of strokes and stroke-like events in the elderly population.

Patients or their caregivers should immediately report to their doctors any signs and symptoms of potential strokes such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. Patients or their caregivers should inform their doctors of their past and present medical history, including history of stroke or stroke-like events, and should also consult their doctor prior to making any changes in their medication.

Information about this safety update has been sent to doctors and pharmacists to ensure that they are aware of this new safety information when prescribing and dispensing RISPERDAL. The company is working with Health Canada to update the Canadian prescribing information for RISPERDAL. In the interim, all healthcare professionals are advised to review the healthcare professional letter.

For more information, contact Simone Philogène, Janssen-Ortho, 416-449-9444. Or call the Medical Information Department at 1-800-567-3331 from 9a.m. to 5p.m. Monday to Friday, EST, or visit the company web site at http://www.janssen-ortho.com

Janssen-Ortho Inc. is a research-based pharmaceutical company in Toronto.

* All trademark rights used under license.

Any suspected adverse drug reactions can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The ADR Reporting Form can be found in The Canadian Compendium of Pharmaceuticals and Specialties, or on the TPD web site, along with the ADR Guidelines.

[Text of letter ends]