FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events | Heart and Vascular Health | Scoop.it
FDA is informing the public about a meta-analysis of trials that compared patients who received the smoking cessation drug Chantix (varenicline). FDA first notified the public about a possible increased risk of cardiovascular adverse events with Chantix in its June 2011 Drug Safety Communication (DSC).
The meta-analysis showed higher rates of composite outcomes on Chantix. Although these findings were not statistically significant, they were consistent. It should be noted that the incidence of cardiovascular mortality (Chantix 0.05% [2/4190] vs. placebo 0.07% [2/2812]) and all-cause mortality (Chantix 0.14% [6/4190] vs. placebo 0.25% [7/2812]) was lower in the Chantix group compared to the placebo group, although this finding was also not statistically significant.