The smoking-cessation drug varenicline (Chantix) may increase the risk of cardiovascular events, the FDA said in a updated review.
Patients taking varenicline had higher rates of major cardiovascular events, including death, MI and stroke than those taking placebo, results of a metaanalysis ordered by the agency and conducted by drug-maker Pfizer showed.
These events were uncommon in both the varenicline and placebo groups (0.31% in the varenicline group vs. 0.21% in the placebo group during a 30 day period), the FDA said, and the increased risk was not statistically significant.
The drug’s warning label was updated in June 2011 to contain a information about heart risks, after a randomized controlled clinical trial showed higher rates of cardiovascular events in patients taking varenicline. The FDA requested the current metaanalysis at that time.
A boxed warning was added to varenicline’s labeling in 2009 after reports of neuropsychiatric symptoms, including depression and suicidality.