Chantix Faces Canadian Safety Review
Jun 28, 2011 | Parker Waichman LLP
A week after the U.S. Food & Drug Administration (FDA) announced a label change for Chantix after a study linked it to a higher risk of heart problems in people with pre-existing cardiovascular disease, regulators in Canada - where the drug is sold as Champix - said they are conducting their own safety review.
The study that prompted both agencies to act assessed Chantix for smoking cessation in 700 patients aged 35 to 75 years with stable, documented cardiovascular disease (other than, or in addition to, hypertension). Two percent of Chantix patients suffered a heart side effect, compared to 1% for those taking no drug.
The problems seen in the study included heart attack, infrequent chest pain, need for coronary revascularization, and peripheral vascular disease. This included seven non-fatal heart attacks in Chantix patients versus 3 in the placebo group.
In its announcement, Health Canada said it is evaluating this new study and all other available information. The agency said it will take appropriate action as necessary based on the results of its review. Canadians will be updated with any new safety recommendations regarding Champix use.
In the U.S., a Chantix heart warning is being added to the "Warnings and Precautions" section of the drug’s label. The agency is also requiring Pfizer, the maker of Chantix, to conduct an analysis of earlier clinical trials to evaluate the drug’s heart side effects.
In the U.S, Chantix also bears a black box warning regarding its association with psychiatric side effects, including suicidal thoughts and behavior.
