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Multaq (dronedarone) – Information on Important Revisions to Product Monograph – For the Public

Starting date:
December 8, 2011
Posting date:
December 8, 2011
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-19000971

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 (dronedarone)

December 8, 2011

Subject: Information on important new changes on use of Multaq® (dronedarone).

Sanofi-aventis Canada Inc., in collaboration with Health Canada, would like to inform patients of important safety information related to the use of the heart drug Multaq (dronedarone).

Multaq helps to control an abnormal heart rhythm called atrial fibrillation and can lower the risk of hospitalization due to heart problems.

Information from a large international study (called "PALLAS") suggests that patients on Multaq with permanent atrial fibrillation may be more at risk for serious heart-related events, as compared to patients not on the drug. Permanent atrial fibrillation is a type of atrial fibrillation in which a decision has been made not to try to change the heart rhythm back to normal. The PALLAS study has been stopped, and healthcare professionals have been informed of these results.

As a result, the Multaq Product Monograph (the reference document that healthcare professionals use when prescribing a drug) has been modified.

  • Patients should discuss these new recommendations on the use of Multaq with their healthcare professional.
  • Patients should not stop treatment with Multaq without talking to their healthcare professional.

Patients should not take Multaq if:

  • they have signs of heart failure such as shortness of breath, swelling of their feet or legs, trouble breathing while lying down or sleeping, shortness of breath while moving around;
  • they have a type of atrial fibrillation called permanent atrial fibrillation (AF);
  • there is a conduction problem within their heart's electrical system;
  • their heart does not function well as a pump;
  • they have had liver or lung problems from taking a drug called amiodarone.

Sanofi-aventis has worked with Health Canada to include this new safety information in the Multaq Product Monograph.

Patients should speak with their healthcare professional if they have any related concerns or if they notice any unexpected or worsening symptoms while taking Multaq. Patients should also see their health care professional on a regular basis while taking Multaq.

Managing marketed health product-related adverse reactions depends on healthcare 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 serious heart or lung-related adverse reaction or other serious or unexpected adverse reactions in patients receiving Multaq 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
Phone: 1-800-265-7927

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 MedEffect™ Canada
  • 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
      K1A 0K9

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

Sincerely,

original signed by

Franca Mancino, M.Sc.
Senior Director, Regulatory Affairs, Pharmacovigilance &
Medical Quality and Compliance