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Health professional risk communication

Revlimid (lenalidomide) - Risk of Liver Problems - For the Public

Starting date:
December 27, 2013
Posting date:
December 27, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
New safety information
Audience:
General Public
Identification number:
RA-37385

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 REVLIMID® (lenalidomide capsules)

December 27, 2013

Subject: Updated Safety Information regarding REVLIMID® (lenalidomide) and the risk of liver problems

Celgene Inc., in collaboration with Health Canada, would like to inform you of important new information related to the safety of REVLIMID® (lenalidomide capsules).

Health Canada has authorized REVLIMID® for the treatment of patients with a condition called deletion 5q myelodysplastic syndrome (del 5q MDS) which requires blood transfusions for anemia (low red blood cell counts). REVLIMID is also used with the medicine dexamethasone to treat people with multiple myeloma, a cancer of blood cells, who have already received another medicine.

Information regarding the risk for liver problems has been strengthened in the Canadian label for REVLIMID®.

  • Treatment with REVLIMID® may lead to a higher risk of liver problems, which in rare situations, may cause death.
  • Before you use REVLIMID®, you should tell your doctor or pharmacist if you have a history of liver problems or if you are taking other medicines.

Celgene Inc. has sent a letter to Canadian health care professionals informing them of this safety information. You may view this letter on the Healthy Canadians Web site.

REVLIMID® 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 REVLIMID®.

For a complete list of side effects associated with REVLIMID®, please refer to the REVLIMID® Product Monograph available at http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp or www.RevAid.ca. Ask your health care provider or pharmacist for more information.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of liver problems or other serious or unexpected adverse reactions in patients receiving REVLIMID® 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 REVLIMID® or the RevAid® controlled distribution program, please call 1-888-RevAid1 (1-888-738-2431).

Sincerely,

original signed by

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

 

Date modified: