While a Canadian study reportedan association between Champix and increased risk of cardiovascular accidents, the European Medicines Agency (EMA) announced yesterday that the benefit-risk balance of the drug prescribed for smoking cessation remained positive. The EMA’s Committee for Medicinal Products for Human Use claims to have noted many limitations in the Canadian study, presented on July 5.
The European Agency has nevertheless asked Pfizer, which markets Champix, to include additional information on cardiovascular events in the product leaflet. Indeed, according to an American study conducted on 700 smokers, the main molecule of Champix, varenicline, can worsen cardiovascular problems in people already with heart problems.
In France, Nora Berra, Secretary of State for Health, recalled on May 31, on World No Tobacco Day, that Champix would soon no longer be reimbursed by Health Insurance,