CHAMPIX (varenicline tartrate) and ZYBAN (bupropion hydrochloride) - Revision to the Consumer Information of Non-Nicotine Smoking Cessation Aids - For the Public

Starting date:
May 30, 2013
Posting date:
May 30, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-33623

This is duplicated text of a letter from Pfizer Canada Inc. and Valeant Canada LP. 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 CHAMPIX (varenicline tartrate) and ZYBAN (bupropion hydrochloride)

May 30, 2013

Subject: Revision to the Consumer Information of Non-nicotine Smoking Cessation Medicines CHAMPIX® (varenicline tartrate) and ZYBAN® (bupropion hydrochloride)

Pfizer Canada Inc. (manufacturer of CHAMPIX®) and Valeant Canada LP (manufacturer of ZYBAN®), in collaboration with Health Canada, would like to inform you about safety information for these anti smoking drugs.

CHAMPIX (varenicline tartrate) and ZYBAN (bupropion hydrochloride) are non-nicotine prescription drugs used to quit smoking and each should be used with supportive counselling. ZYBAN can be used together with nicotine replacement therapy.

New information for CHAMPIX and ZYBAN has been added to the Product Monographs (PMs), the reference documents that healthcare professionals use when prescribing drugs. The PMs for these drugs indicate now that nicotine replacement therapy (patches, gum, lozenges, etc.) should be considered before taking non-nicotine medicines, like CHAMPIX and ZYBAN.

  • Your healthcare professional will discuss with you the potential benefits and side effects of available treatments that may help you to quit smoking.
  • Before trying CHAMPIX or ZYBAN, you and your healthcare professional should consider a nicotine replacement therapy (patches, gum, lozenges, etc.).

Please refer to the CHAMPIX Product Monograph for complete details.

Please refer to the ZYBAN Product Monograph for complete details.

This revision was based on available information about the treatments used to help people stop smoking. The intent of this change, and of this communication, is to encourage patients to discuss all the treatment options with their doctors. Nicotine replacement therapy should be considered before non-nicotine replacement therapy (CHAMPIX or ZYBAN).

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 serious or unexpected adverse reactions in patients receiving a medicine to help quit smoking should be reported to the relevant product manufacturers or to Health Canada.

If you have any questions concerning this information, please contact Medical Information at Pfizer Canada or Valeant Canada LP as per contact information below.

Contact information for manufacturer of CHAMPIX
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, QC H9J 2M5
Telephone: 1-800-463-6001

Contact information for manufacturer of ZYBAN
Valeant Canada LP
2150 St. Elzéar West
Laval, QC, H7L 4A8
Telephone: 1-800-361-4261

You can report any suspected side effect associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
     
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

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

Sincerely,

original signed by

Bernard Prigent, MD, MBA
Vice-President and Medical Director
Pfizer Canada Inc.

Nariné Demirchian B. Sc.
Associate Director, Regulatory Affairs
Valeant Canada LP