Chantix, Stop-Smoking Drug Linked to Heart RisksPosted in Product Liability Keith Belt
Consumers must be aware that many pharmaceutical products on the market may cause adverse reactions to certain segments of the users, Alabama product liability attorney Keith T. Belt says
Users of the smoking-cessation drug varenicline (Chantix) had a small but statistically significant increase in the risk of cardiovascular events, a meta-analysis of randomized trials showed
The analysis, published online in CMAJ, showed that 1.06% of varenicline-treated study participants had serious adverse cardiovascular events compared with 0.82% in placebo-treated participants. The difference translated into an odds ratio of 1.72 for varenicline versus placebo, which in absolute terms, is a small difference, according to research at Johns Hopkins and Mayo Clinic. However, when you consider the difference from a population perspective, you get a very different picture with an estimated 7 million people in the U.S. were using Chantix last year. When applying these results to the total number of U.S. Chantix users, researchers estimate that there were 62,500 cardiac events in 2010 that were linked to use of Chantix, which is not a small number, by any standards
The report follows an FDA announcement last month that prescribing information for varenicline will be revised to include a warning about an increased risk of second heart attack and peripheral artery disease in people with a history of cardiovascular disease
Primary source: CMAJ
Singh S et al “Risk of serious adverse cardiovascular events associated with varenicline: A systematic review and meta-analysis” CMAJ 2011; DOI: 10.1503/cmaj.110804.