ANZEMET (dolasetron mesylate) - Withdrawal of 20 mg/mL Intravenous Injection Due to Potential Risk of Arrhythmias - For Health Professionals

Starting date:

April 26, 2011

Posting date:

April 28, 2011

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002399

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

Health Canada Endorsed Important Safety Information on Anzemet intravenous injection

April 26, 2011

Subject: Withdrawal of Anzemet^® (dolasetron mesylate) 20 mg/mL intravenous injection due to potential risk of arrhythmias

Dear Health Care Professional,

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

New data^{Footnote 1} have shown that intravenous administration of the injectable form of Anzemet^® (dolasetron mesylate) is associated with QTc prolongation, to an extent which may potentially result in serious arrhythmias at the doses recommended for the prevention of nausea and vomiting. Sanofi-aventis Canada Inc. will be removing the injectable form from the Canadian market as of May 10, 2011.

• Anzemet^® (dolasetron mesylate) 20 mg/mL injection should no longer be used to prevent nausea and vomiting associated with chemotherapy. (Market withdrawal date May 10, 2011).
• Anzemet^® tablets for oral administration may still be used in the conditions described in the Anzemet^® Product Monograph.
• Alternative intravenous therapies should be considered for the prevention of nausea and vomiting associated with emetogenic chemotherapy.

Anzemet^® is currently indicated to prevent chemotherapy-induced nausea and vomiting in adults undergoing initial and repeat courses of emetogenic cancer chemotherapy, including high dose cisplatin.

The injectable form of Anzemet^® should no longer be used to prevent nausea and vomiting associated with chemotherapy. However, Anzemet^® tablets for oral use may still be used as the risk of developing an abnormal heart rhythm with the oral form of this drug is considered less than that seen with the injectable form.

Caution should be exercised with respect to the administration of Anzemet^® tablets in patients with renal impairment, elderly patients and in patients with conditions which increase the risk of arrhythmias, such as underlying heart conditions, existing heart rate or rhythm problems, concomitant use of drugs known to affect ECG, bradycardia, and electrolyte imbalance.

The Canadian Product Monograph of Anzemet^® tablets will be updated to include this new safety information.

Since its initial market authorization in Canada in 1997, the Product Monograph of  Anzemet^® (dolasetron mesylate) has carried warnings about the effect of this drug on the electrical activity of the heart, observed in electrocardiograms (ECGs) as prolongation of the QTc, QRS and PR intervals. Due to cardiac safety concerns, two contraindications were previously included in the Anzemet^® tablets and injection Product Monograph^{Footnote 2}: 1) a contraindication for any use in the pediatric population; and, 2) a contraindication for prevention and treatment of post-operative nausea and vomiting in adults.

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 serious arrhythmia or other serious or unexpected adverse reactions 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™ 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

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Sincerely,

original signed by

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