Non-Hyperimmune Immunoglobulin Products - Changes to Canadian Product Monographs - Notice to Hospitals
- Starting date:
- October 9, 2014
- Posting date:
- October 9, 2014
- Type of communication:
- Notice to Hospitals
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals
- Identification number:
NOTICE TO HOSPITALS - Health Canada Issued Important Safety Information on Non-Hyperimmune Immunoglobulin Products
October 9, 2014
To: Hospital Chief of Medical Staff
Please distribute to the relevant Departments of Blood Bank, Emergency Medicine, Hematology, Immunology, Neurology, Oncology, Rheumatology and/or other Departments as required and other involved professional staff and post this NOTICE in your institution.
Subject: Thromboembolic Events and Non-Hyperimmune Immunoglobulin Products – Changes to Canadian Product Monographs of GamaSTAN® S/D, Gammagard Liquid, Gammagard S/D, Gamunex®, Hizentra®, IGIVnex®, Immune Serum Globulin (Human), Octagam® 5%, Octagam® 10%, and Privigen®
Health Canada, in collaboration with Baxter Corporation, CSL Behring Canada, Grifols Therapeutics Inc. and Octapharma Canada Inc., wishes to inform you of changes to all Canadian Product Monographs related to the risk of thromboembolic events in patients using non-hyperimmune immunoglobulins.
The following summary briefly notes the key messages regarding the changes:
- Thromboembolic events can occur in patients using immunoglobulins regardless of dose or route of administration.
- Thromboembolic events can occur in patients in the absence of known risk factors, such as advanced age, obesity, diabetes, prolonged immobilization, a history of hypercoagulability or thrombotic events, use of estrogens, indwelling central vascular catheters, and hyperviscosity.
- Canadian Product Monographs for all non-hyperimmune immunoglobulins were updated to include thromboembolic events in the Serious Warnings and Precautions.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious thromboembolic events or other serious or unexpected adverse reactions in patients receiving non-hyperimmune immunoglobulin products should be reported to the specific manufacturer or Health Canada at the following address:
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
Calling toll-free at 1-866-234-2345, or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate