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THALOMID (thalidomide capsules) - Risk of Second Cancers - For the Public

Starting date:
May 22, 2013
Posting date:
May 22, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product label update
Audience:
General Public
Identification number:
RA-29249

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 22, 2013

Subject: Association of THALOMID® (thalidomide capsules) with risk of second cancers

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

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

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®.

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

  • Second cancers, namely acute myeloid leukemia and myelodysplastic syndrome, which are different types of blood cancer, have been reported in a small number of patients taking THALOMID® in combination with melphalan and prednisone.
  • Patients should talk to their doctors or pharmacists if they have any concerns about their own increased risk of getting these or other cancers.

This information on second cancers has been added into the Canadian Product Monograph (CPM), the reference document that healthcare professionals use when prescribing a drug, and the Consumer Information Leaflet (CIL), part of the CPM. Celgene Inc. has sent a letter to Canadian healthcare professionals informing them of this safety information. You may view this letter on Health Canada’s Web site.

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 in the Canadian Product Monograph.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of second cancer or other serious or unexpected side effects 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 RevAid.

Sincerely,

original signed by

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

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