Revlimid (lenalidomide) – Association with an Increased Risk of Second Cancers – For the Public

Starting date:

May 3, 2012

Posting date:

May 3, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-190001081

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)

May 3, 2012

Subject: Association of REVLIMID^® (lenalidomide) with risk of second cancers

Celgene Inc., in consultation with Health Canada, has informed Canadian healthcare providers of important 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) who require blood transfusions for anemia (low red blood cell counts). REVLIMID^® is also authorized when used with dexamethasone to treat patients with multiple myeloma who have already had another treatment. Multiple myeloma is a cancer of plasma cells. 

Celgene Inc. has worked with Health Canada to update the REVLIMID^® Product Monograph with the following safety information:

• Second cancers such as skin cancers or other invasive solid tumors have been reported in a small number of patients with multiple myeloma.


• These cases have been reported in patients while taking REVLIMID^® or after treatment with REVLIMID^® is completed.


• Patients should talk to their healthcare professionals if they have any concerns about their own increased risk of having other cancers.

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 in the Drug Product Database Online Query or on the RevAid Web site. Ask your health care provider or pharmacist for more 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 second cancer 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)

To report suspected adverse reactions to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or visit the MedEffect^TM Canada Web site for information on how to report.

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect^TM Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

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