Multaq (dronedarone) - Information on Increase in Heart-Related Events in Patients with Permanent Atrial Fibrillation - For the Public

Starting date:

August 4, 2011

Posting date:

August 4, 2011

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-15923

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)

August 4, 2011

Subject: Updated safety information on Multaq (dronedarone) related to an increase in heart-related events in patients with permanent atrial fibrillation.

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

Multaq helps to control an abnormal heart rate and rhythm called atrial fibrillation and can lower the risk of having to go into the hospital for heart problems.

Early 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. The study has been stopped, and healthcare professionals have been informed of these results.

• Patients on Multaq should talk to their healthcare professional if they have questions or concerns.
• Patients should not stop treatment with Multaq without talking to their healthcare professional.
• Permanent atrial fibrillation can only be diagnosed by a healthcare professional.

It is important to understand that permanent atrial fibrillation is only one type of atrial fibrillation. The PALLAS study was about the use of Multaq in patients with permanent atrial fibrillation.  The data is preliminary and needs more analysis to confirm results.

Sanofi-aventis is working with Health Canada for the Multaq Product Monograph (the reference document that healthcare professionals use when prescribing a drug) to reflect this new safety information.

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 such as increasing shortness of breath, swelling of feet or legs, trouble breathing while lying down or sleeping and/or shortness of breath while moving around.

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 cardiovascular 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

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 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
    
    Ottawa, Ontario K1A 0K9

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@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Stanislav Glezer, M.D.

Vice President, Medical Affairs

Sanofi-aventis Canada Inc.