Health professional risk communication

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

Starting date:
May 27, 2013
Posting date:
May 30, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-33621

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

Health Canada Endorsed Important Safety Information on CHAMPIX (varenicline tartrate) and ZYBAN (bupropion hydrochloride)

May 27, 2013

Dear Healthcare Professional,

Subject: Revision to the Product Monographs (PMs) of Non-nicotine Smoking Cessation Aids CHAMPIX® (varenicline tartrate) and ZYBAN® (bupropion hydrochloride)

Pfizer Canada Inc. and Valeant Canada LP, in collaboration with Health Canada, would like to inform you of revisions to the Product Monographs (PMs) for non-nicotine smoking cessation aids CHAMPIX® (varenicline tartrate) and ZYBAN® (bupropion hydrochloride).

CHAMPIX is a smoking cessation pharmacological treatment to be used in conjunction with smoking-cessation counselling.

ZYBAN is a smoking cessation pharmacological treatment to be used in conjunction with behavioural modification. In addition, ZYBAN is indicated for use with nicotine replacement therapy.

The following key statements have been added to the PMs for the class of non-nicotine smoking cessation aids (CHAMPIX and ZYBAN):

  • Prior to a decision to prescribe a non-nicotine treatment, CHAMPIX or ZYBAN, thorough consideration should be given to the treatment option of nicotine replacement therapy.
  • In many cases, nicotine replacement therapy should be tried before prescribing CHAMPIX or ZYBAN.

Please refer to CHAMPIX and ZYBAN Product Monographs for complete details.

These revisions to the PMs are based on continuing post-marketing surveillance and mechanisms of action of non-nicotine products. The PM revisions and this communication are intended to reinforce the importance of a discussion with patients about the expected potential benefits and risks associated with the use of smoking cessation therapies.

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 serious or unexpected adverse reactions in patients receiving smoking cessation products 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 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

To correct your mailing address or fax number, contact Pfizer Canada for CHAMPIX, or Valeant Canada for ZYBAN.

You can report any suspected adverse reactions 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