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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Janssen-Ortho Inc.
Contact the company for a copy of any references, attachments or enclosures. |
| Health Canada Endorsed Important Safety Information on
REMINYL* (galantamine hydrobromide) |
April 18, 2005
Subject: Safety Information from Investigational Studies with REMINYL* (galantamine hydrobromide) in Mild Cognitive Impairment (MCI)
Dear Health Care Professional,
Janssen-Ortho Inc., in consultation with Health Canada, would like to inform you of important safety information regarding REMINYL* (galantamine hydrobromide). In January 2005, Janssen-Ortho Inc., in consultation with Health Canada, issued a public advisory regarding the results of two investigational trials in patients with MCI. REMINYL is approved for the symptomatic treatment of patients with mild to moderate dementia of the Alzheimer's type. No indication is being sought for the treatment of individuals with MCI.
The REMINYL Product Monograph has been revised to include information regarding the results of the studies in MCI.
Changes to the REMINYL Product Monograph will include:
- Information under WARNINGS AND PRECAUTIONS regarding a difference in mortality with REMINYL (13 fatalities; n=1026) compared to placebo (1 fatality; n=1022) in two investigational trials in MCI. The reason for this difference is currently unknown. This difference in mortality has not been observed in REMINYL studies in Alzheimer's Disease.
- In these trials, REMINYL was not shown to be effective in patients with MCI.
- There is no evidence of an increased risk of mortality when REMINYL is used in patients with mild to moderate Alzheimer's Disease.
- A reminder to health care professionals under DOSAGE AND ADMINISTRATION that REMINYL is not indicated for use in patients with MCI.
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WARNINGS AND PRECAUTIONS, Special Populations
Patients with Mild Cognitive Impairment (MCI):
Mortality in Investigational Trials in MCI
Two randomized, double-blind, placebo-controlled efficacy and safety studies of 2 years' duration were completed in non-demented subjects with MCI. Individuals with MCI demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimer's Disease. In these trials, REMINYL was not shown to be effective in patients with MCI. In the double-blind portion of these two trials, a total of 13 deaths in subjects on REMINYL (n=1026) were recorded and 1 death in subjects on placebo (n=1022); the reason for this difference is currently unknown. This difference in mortality has not been observed in REMINYL studies in Alzheimer's Disease. Approximately half of the REMINYL deaths appeared to have resulted from various vascular causes (myocardial infarction, stroke, and sudden death); other deaths appeared to have resulted from infection, suicide and cancer. There is no evidence of an increased risk of mortality when REMINYL is used in patients with mild to moderate Alzheimer's Disease.
DOSAGE AND ADMINISTRATION
REMINYL (galantamine hydrobromide) and REMINYL ER are not indicated for use in patients with mild cognitive impairment (see WARNINGS AND PRECAUTIONS, Special Populations, Patients with Mild Cognitive Impairment (MCI):, Mortality in Investigational Trials in MCI).
The use of REMINYL is not advised outside of its approved indication. Patients should be treated according to the approved Canadian prescribing information.
Please refer to the attached highlighted copy of the Prescribing Information for the revisions to the Product Monograph. Please insert this revised Prescribing Information in your copy of the Compendium of Pharmaceuticals and Specialties (CPS) and use when prescribing or dispensing REMINYL. The revised Product Monograph is also available on the Janssen-Ortho website at  http://www.janssen-ortho.com.
Janssen-Ortho Inc. continues to work closely with Health Canada to monitor ongoing clinical trials, and worldwide pharmacovigilance reports. Janssen-Ortho Inc. will continue to provide you with the most current and complete product information available for the management of patients receiving REMINYL.
The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of serious and/or unexpected adverse reactions in patients receiving REMINYL should be reported to Janssen-Ortho Inc. or the Marketed Health Products Directorate at the following addresses:
Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Or call toll free at 1-800-567-3331
Or email to dsscan@joica.jnj.com
Or toll free fax to 1-866-767-5865
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries, please refer to contact information:
Bureau of Cardiology, Allergy and Neurological Sciences
bcans_enquiries@hc-sc.gc.ca
Tel: (613) 941-1499
Fax: (613) 941-1668
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties. |
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
Should you have any questions or require additional information regarding the use of REMINYL, please contact Janssen-Ortho Inc. Medical Information Department at 1-800-567-3331 from 9:00 am to 5:00 pm Monday to Friday Eastern Standard Time (EST) or by facsimile at 416-449-5248. A copy of this letter is also available on the Janssen-Ortho website at http://www.janssen-ortho.com and on the Health Canada website at http://www.hc-sc.gc.ca/dhp-mps/index_e.html.
Sincerely,
original signed by
Wendy Arnott, Pharm.D.
Vice President
Regulatory, Safety and Quality
*All trademark rights used under license.
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