The FDA reviewed data on 700 smokers with cardiovascular disease who were treated with either Chantix or placebo. Those individuals who took Chantix were more likely to quit smoking for at least one year, but the drug did slightly increase their risk for developing heart problems including heart attacks, when compared with their counterparts who took placebo. Information on this potential risk will now be added to Chantix’s label and included in a patient medication guide.
The FDA will continue to monitor for risk of heart problems in Chantix users and is now requiring that Chantix manufacturer Pfizer analyzes all of the available data to get a better handle on the potential heart risks associated with the use of this drug.
In a statement, Pfizer pointed out that the overall number of cardiovascular events seen among Chantix users with heart disease was low.
Bruce Darrow, MD, PhD, an assistant professor of cardiology/medicine with the Mount Sinai School of Medicine in New York City, says in a statement that “it’s too early to conclude that Chantix shouldn’t be given to any patients with existing heart disease and many of the benefits of stopping smoking could be expected to be apparent beyond the one year period reported here.”
He adds that “even though these problems occurred in a small number of patients, it’s enough to suggest that doctors consider other ways of getting their patients to quit smoking before prescribing Chantix.”
Chantix has also been linked to emotional or mood changes including agitation, depression, and suicidal thoughts.