New safety information regarding Champix (varenicline tartrate) - For the Public

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Pfizer Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on CHAMPIX (varenicline tartrate)

2008-06-13

Subject: New safety information regarding CHAMPIX^® (varenicline tartrate)

CHAMPIX (varenicline tartrate) is one treatment option available to help quit smoking. Pfizer Canada in consultation with Health Canada is advising consumers of important safety information regarding CHAMPIX^®. Since the introduction of CHAMPIX in Canada, in April 2007 through April 30, 2008, a total of 226 Canadian cases of neuropsychiatric adverse events have been reported. For the same time period, there have been 708 534 prescriptions filled for CHAMPIX in Canada¹.

Quitting smoking can also be associated with changes in mood and behaviour, with or without taking medication to help quit. A doctor or pharmacist should be consulted should these symptoms or those described above be experienced, since guidance has been provided to healthcare professionals on how to use CHAMPIX in patients, including those patients who may also have mental health problems.

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. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

This information does not take the place of patients talking with their doctor/pharmacist about their condition or treatment. Patients, their family or caregiver are encouraged to speak with the doctor about any questions or concerns that they may have.

Health Canada issued an article concerning CHAMPIX in the Canadian Adverse Reaction Newsletter (CARN) in April 2008.

Any case of serious change in mood or behavior or other serious or unexpected adverse reactions in patients receiving CHAMPIX should be reported to Pfizer Canada Inc. or Health Canada at the following addresses:

Sincerely,

original signed by

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

Reference:
1. IMS compuscript weekly (April 30, 2008).