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THALOMID (thalidomide capsules) - Risk of Arterial Blood Clots - For Health Professionals
- Starting date:
- April 26, 2013
- Posting date:
- May 1, 2013
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from Celgene Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on THALOMID (thalidomide capsules)
April 26, 2013
Dear RevAid® Registered Prescriber, RevAid® Registered Pharmacist, or Allied Healthcare Professional:
Subject: Association of THALOMID® (thalidomide capsules) with arterial thromboembolic events
Celgene Inc., in consultation with Health Canada, would like to inform you of important new safety information regarding arterial thromboembolic events which have been added to the Product Monograph for THALOMID® (thalidomide capsules).
THALOMID® is an immunomodulatory agent indicated for the treatment of patients who are 65 years of age or older with previously untreated multiple myeloma, in combination with melphalan and prednisone.
The following points summarize the updated Product Monograph safety information:
- Cases of arterial thromboembolic events (ATEE), sometimes fatal, have been reported in patients treated with THALOMID®. Events reported included myocardial infarction, cerebrovascular accident and transient ischemic attack, among others. The risk of thromboembolism (including ATEE) appears to be greatest during the first 5 months of therapy.
- Risk factors associated with ATEE (in addition to the underlying malignant disease, age ≥ 65 years, and being male) include hyperlipidemia, hypertension, diabetes, obesity, renal disease and tobacco use.
- Healthcare professionals are advised to be observant for the signs and symptoms of ATEE. Patients should be instructed to seek medical care if they develop symptoms related to stroke or heart attack. Thromboprophylaxis should be recommended especially in patients with additional thrombotic risk factors. The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors.
The THALOMID® Canadian Product Monograph has been revised to include the updated risk information specific to arterial thromboembolic events within the Warnings and Precautions and Adverse Reactions sections as well as the Consumer Information section. This new information is in addition to information regarding the established risk of venous thromboembolic events, which was already reflected in the THALOMID® Product Monograph.
A copy of the most up-to-date THALOMID® Product Monograph can be found on the Health Canada Web site.
Distribution restrictions: THALOMID® is only available through a controlled distribution program called RevAid®. Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense the product. In addition, THALOMID® can only be dispensed to patients who are registered and agree to the requirements of the RevAid® program. For more information, please log onto www.RevAid.ca.
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 case of arterial thromboembolism or other serious or unexpected adverse reactions in patients receiving THALOMID® should be reported to Celgene Inc. or Health Canada.
Suspected adverse reactions can be reported to:
6755 Mississauga Road, Suite 600, Mississauga, ON, L5N 7Y2
To correct your mailing address or fax number, contact Celgene Inc.
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, please contact Health Canada at:
Marketed Health Products Directorate
Should you have any questions about THALOMID® or the RevAid® controlled distribution program, please call 1-888-RevAid1 (1-888-738-2431) or visit www.RevAid.ca
original signed by
Dianne Azzarello, B.Sc.Phm.
Senior Director, Pharmacovigilance & Regulatory Affairs
THALOMID® and RevAid® are registered trademarks of Celgene Corporation.
- Date modified: