New research appears to question the findings of previous studies, which have warned about the risk of heart problems associated with the smoking cessation drugs Chantix and Zyban.
In a study published this week in the medical journal JAMA Internal Medicine, researchers from the University of California, San Francisco, said they could find no association between the use of Chantix or Zyban and serious cardiovascular events.
The research involved a randomized clinical trial of more than 8,000 smokers. Some were given a placebo, while others were given Chantix, Zyban, nicotine replacement therapy or a nicotine patch. The findings indicated that there was no significant difference between the groups in the rates of cardiovascular death, nonfatal heart attacks or strokes.
Chantix (varenicline) is a prescription medication introduced by Pfizer in 2006, designed to help people quit smoking. However, less than three years later, the FDA required Pfizer to add a “black box” warning, following a number of reports involving suicide and other unusual behavior among users.
A black box is the strongest label warning the FDA can require a drug maker to apply, alerting doctors and patients to a potential link between use of the Chantix or Zyban and the emergence of suicidal or homicidal thoughts.
Pfizer, the manufacturer, fought to get the label warning removed, and succeeded in December 2016.
However, a year later, Canadian researchers published a study in the American Journal of Respiratory and Critical Care Medicine, which involved medical records on 57,000 new Chantix users. Their findings indicated that the smoking cessation drug appeared to increase the risk of hospitalization due to cardiovascular events by 57%.
This latest study sought to address the concerns raised by that study.
“These findings provide evidence that, in a general population of smokers, smoking cessation medications do not increase the risk of serious cardiovascular events,” the researchers of the latest study concluded.