Because I was on vacation when the latest Chantix (varenicline) news broke, I’m a week late in posting on it. Last Monday, a meta-analysis was published online in the Canadian Medical Association Journal. The meta-analysis, which combined 14 Chantix clinical trials involving 8216 partcipants, showed a 72% increased risk of ischemic or arrhythmic adverse cardiovascular events. Moreover, all except one trial involving approximately 700 participants excluded patients with a history of cardiovascular disease, indicating that Chantix may have heart risks even for people without a history of heart trouble. The meta-analysis follows last month’s FDA warning that Chantix may raise the risk of cardiovascular events in persons with a history of cardiovascular disease.

A number of people have raised safety concerns with Chantix since it was approved in 2006, including John Spangler and Curt Furberg of Wake Forest University School of Medicine (see background here, here and here), both of whom were co-authors on the meta-analysis. In 2008, researchers at the Institute for Safe Medication Practices issued a report showing a high rate of serious adverse events associated with the drug. In response to the ISMP report, the Federal Aviation Administration said it would no longer permit pilots or air traffic controllers to use Chantix, and the Federal Motor Carrier Safety Administration advised medical examiners to not qualify anyone currently using Chantix for a commercial motor vehicle license. The Chantix label includes a warning that Chantix may impair driving ability. The label also contains a boxed warning relating to Chantix’s psychiatric risks. Last year, a study published in The Annals of Pharmacotherapy found that Chantix was associated with violent or aggressive thoughts and acts. A study in PLoS One found that Chantix was associated with acts of violence toward others.

In my opinion, smokers should rely on other methods to stop smoking, such as nicotine replacement therapy, bupropion or counseling, rather than using Chantix.