Health Canada Reviewing Champix for Heart Side Effects

Health Canada is reviewing the smoking cessation drug Champix (sold as <"">Chantix is the U.S.) for a possible link to heart problems. The Health Canada announcement follows last week’s notification by the U.S. Food & Drug Administration (FDA) that the label for Chantix was being updated to include information about the drug’s possible association with heart problems in patients with pre-existing cardiovascular disease.

Both the U.S. labeling change and the Health Canada announcement were prompted by a study that 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). In this trial, Chantix was effective in helping patients quit smoking and remain abstinent from smoking for as long as one year. But while cardiovascular adverse events were infrequent overall, some were reported more frequently among Chantix patients. These included heart attack, infrequent chest pain, need for coronary revascularization, and peripheral vascular disease.

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 last week’s announcement, the FDA warned Chantix users to seek medical attention if they experience any symptoms of cardiovascular disease while taking the drug, including:

• Shortness of breath or trouble breathing
• New or worsening chest pain
• New or worse pain in legs when walking

The benefits of Chantix should be weighed against potential risks in patients with heart disease, the FDA said. The agency is requiring that Pfizer, the maker of Chantix, conduct a large study through randomized, placebo-controlled trials to assess the cardiovascular safety of the product.

The FDA approved Chantix in 2006 as a treatment for smoking cessation. Chantix blocks nicotine by targeting the brain’s nicotine receptor. In 2009, the FDA announced that a Boxed Warning would be added to the Chantix label for serious psychiatric side effects. Recently, drug regulators in France, where the drug is called Champix, announced that the country’s health insurance program would no longer cover the medication because of its association with psychiatric side effects.

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