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Multaq (dronedarone) – Updated Safety Information in Regards to Hepatocellular Liver Injury – For the Public

Starting date:
March 15, 2011
Posting date:
March 15, 2011
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-19000976

This is duplicated text of a letter from Sanofi-aventis Canada 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 Multaq

March 15, 2011

Subject: Updated Safety Information for Multaq® (dronedarone) related to liver injury

Sanofi-aventis Canada Inc., in collaboration with Health Canada would like to inform patients of new important safety information related to liver injury, reported in patients treated with Multaq. Multaq helps control abnormal heart rate and rhythm called atrial fibrillation and can lower the risk of having to go into the hospital for heart problems.

  • Patients should discuss with their healthcare professionals this new safety information regarding Multaq treatment.
  • Patients treated with Multaq should immediately report to their doctors symptoms possibly suggesting liver injury (such as: Loss of appetite, nausea, vomiting, unusual tiredness, right upper stomach area pain or discomfort, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, or itching) and patients should consider obtaining periodic liver function tests.

Sanofi-aventis has been working with Health Canada, and the Multaq Product Monograph was revised to include this new safety information.

Please speak with your doctor or pharmacist if you have any related concerns or if you experience any other unexpected effects while taking Multaq.

Managing marketed health product-related side effects depends on health professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported side effects of marketed products are generally presumed to underestimate the risks associated with health product treatments. Any case of serious liver injury or other serious or unexpected side effects in patients receiving Multaq (dronedarone hydrochloride) should be reported to sanofi-aventis Canada Inc. or Health Canada at the following addresses:

Sanofi-aventis Canada Inc.
2150 St-Elzear Blvd. West
LAVAL, Quebec
H7L 4A8
Telephone: 1-800-267-7927

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at MedEffectTM Caanda
  • Call toll-free at 1-866-234-2345
  • Complete a Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario   K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax:613-952-7738

Should you have any questions regarding the new important safety update, please contact sanofi-aventis Canada Inc. toll free at 1-800-265-7927.

Sincerely,

original signed by

Monique Furlan, B. Pharm., M. Sc.
Director, Medical Strategy and Regional Operations
sanofi-aventis Canada Inc.