CHAMPIX (varenicline) — Potential Risk Posed by Long-Term Exposure to Nitrosamine Impurity, N-nitrosovarenicline, Exceeding Acceptable Intake Limit

Testing results received from Pfizer Canada ULC identified 5 lots of CHAMPIX with levels of a nitrosamine impurity, N -nitrosovarenicline, above the acceptable intake limit established by Health Canada. N -nitrosovarenicline has been shown to cause gene mutations in an in vitro study, indicating that its presence in CHAMPIX may be associated with a potential increased cancer risk in humans. Health Canada is informing healthcare professionals about the risk associated with these 5 lots.

Product safety