THALOMID (thalidomide capsules) - Risk of Arterial Blood Clots - For the Public

Starting date:
May 1, 2013
Posting date:
May 1, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-26873

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

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on THALOMID (thalidomide capsules)

May 1, 2013

Subject: Risk of blood clots in the arteries with THALOMID® (thalidomide capsules)

Celgene Inc., in discussion with Health Canada, would like to inform you of important information related to the risk of blood clots in the arteries with THALOMID® (thalidomide capsules). 

THALOMID® can only be given to patients who are registered in and meet all conditions of the RevAid® program.  RevAid® is a controlled distribution program of THALOMID®.

Health Canada has authorized THALOMID® to be used with the drugs melphalan and prednisone to treat patients with multiple myeloma who are 65 years of age or older.  Multiple myeloma is a blood cancer.

Celgene Inc. has worked with Health Canada to provide you with the following safety information:

  • While uncommon, blood clots in the arteries can happen in patients taking THALOMID®, especially during the first 5 months of using the drug.  Some of these clots in the arteries have led to death due to heart attack or stroke.
  • A blood clot in your heart can cause chest pain, which can spread to your arms, neck, jaw, back or stomach. You may also feel sweaty, out of breath, and sick to your stomach. These signs may mean you are having a heart attack.  A blood clot in your brain can cause difficulty in seeing or speaking, which may mean you are having a stroke. If you have these symptoms, you should seek medical help immediately.
  • Before you use THALOMID®, you should talk to your doctor or pharmacist and tell them if you smoke, have high blood pressure or high cholesterol levels. These things can increase your risk of getting a blood clot and should be discussed with a health professional.

The information on blood clots in the arteries has been added to the Consumer Information, which already had information about the risk of blood clots in the veins. Celgene Inc. has sent a letter to Canadian health care professionals informing them of this safety information. You may view this letter on Health Canada's website.

To know more about any side effects related to THALOMID® talk to your doctor or pharmacist.  For a complete list of side effects related to THALOMID®, please look at the THALOMID® Consumer Information.

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 a blood clot in an artery or other serious or unexpected adverse reactions in patients receiving THALOMID® should be reported to Celgene Inc. or Health Canada.

Celgene Inc.
6755 Mississauga Road
Suite 600
Mississauga, Ontario
L5N 7Y2
Phone: 1-888-RevAid1 (1-888-738-2431)

You can report any suspected side effect 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
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

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.

Sincerely,

original signed by

Dianne Azzarello, B.Sc.Phm.
Senior Director, Pharmacovigilance & Regulatory Affairs

THALOMID® and RevAid® are registered trademarks of Celgene Corporation.