ANZEMET (dolasetron mesylate) – Withdrawal of 20 mg/mL Intravenous Injection Due to Potential Risk of Arrhythmias – For the Public

Starting date:

April 28, 2011

Posting date:

April 28, 2011

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000951

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 Anzemet intravenous injection

April 28, 2011

Subject: Withdrawal of Anzemet^® (dolasetron mesylate) injection due to potential risk of abnormal heart rhythm

Sanofi-aventis Canada Inc., in collaboration with Health Canada would like to inform patients of the withdrawal of Anzemet^® (dolasetron mesylate) intravenous injection as it is no longer to be used to prevent nausea and vomiting associated with chemotherapy.

Anzemet^® helps prevent nausea and vomiting associated with chemotherapy. It is to be used only in adults.

New data show that the injectable form of Anzemet^® can potentially increase the risk of abnormal heart rhythm which may result in serious cardiac problems at the doses recommended for the prevention of nausea and vomiting. The injection form of Anzemet^® will be removed from the Canadian market as of May 10, 2011.

Sanofi-aventis is working with Health Canada to revise the Product Monograph for Anzemet^® tablets to update this new safety information.

• Anzemet^® injection will no longer be used to prevent nausea and vomiting associated with chemotherapy.
• Anzemet^® tablets for oral use may still be used as per the conditions described in the Anzemet^® Product Monograph.
• Patients treated with Anzemet^® should immediately report to their doctor if they experience any symptoms suggesting abnormal heart rhythm such as: dizziness, palpitations, fainting or seizures.

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

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 heart rhythm problems or other serious or unexpected side effects in patients receiving Anzemet^® (dolasetron mesylate) 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

The Product Monograph and a copy of this Important Safety Information can be accessed online at www.sanofi-aventis.ca

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.

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

Franca Mancino, M.Sc.
Senior Director, Regulatory Affairs, Pharmacovigilance
and Quality and Compliance
sanofi-aventis Canada Inc.