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CHAMPIX (varenicline tartrate) - Changes to the Canadian Product Monograph - For the Public

Starting date:
June 3, 2010
Posting date:
June 3, 2010
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-19000846

This is duplicated text of a letter from Pfizer 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 CHAMPIX (varenicline tartrate)

June 3, 2010

Subject: Important Safety Information regarding CHAMPIX® (varenicline tartrate)

Pfizer Canada, in collaboration with Health Canada, is advising consumers of important changes to the CHAMPIX® Product Monograph and Consumer Information section.

These changes include:

  • Recommendations about neuropsychiatric side-effects (such as changes in mood or behaviour);
  • Information about rare cases of serious allergic and skin reactions;
  • A "What is the most important information I should know about CHAMPIX®?" section for patients; and
  • Another dosing option for your treatment. Your healthcare provider will help decide what dose is right for you.

CHAMPIX® (varenicline tartrate) is a prescription medicine that is used in combination with supportive counselling to help motivated adults quit smoking.

Patients using CHAMPIX® should stop the treatment and contact their healthcare provider immediately if they experience, or if their families or caregivers observe, signs or symptoms including:

  • Changes in mood or behaviour (such as depressed mood, agitation, aggression, hostility, thoughts of self-harm or harm towards others);
  • Serious allergic reactions (such as swelling of the face, lips, gums, tongue and throat that can cause trouble breathing) and skin reactions (such as rash, swelling, redness, and peeling of the skin).

Patients should also be aware that:

  • Neuropsychiatric side-effects have occurred in patients taking CHAMPIX® with or without a history of psychiatric disorder;
  • Quitting smoking can be associated with changes in mood or behaviour, even without taking medication to help quit;
  • Drinking alcohol may increase the risk of experiencing neuropsychiatric side effects; and
  • Side-effects such as sleepiness, dizziness, loss of consciousness, seizures, or difficulty concentrating may also occur. Patients should not engage in potentially hazardous activities, such as driving a car or operating dangerous machinery until they know how they may be affected by CHAMPIX®.

A letter has been posted to healthcare professionals on the Health Canada Web site.

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 or unexpected adverse reactions in patients receiving CHAMPIX® should be reported to Pfizer Canada or Health Canada at the following addresses:

Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, QC H9J 2M5
Telephone: 1-800-463-6001

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701E
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
CanadaVigilance@hc-sc.gc.ca

To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789

Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting 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

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

® C.P. Pharmaceuticals International C.V.
Pfizer Canada Inc., licensee