New Study Warns of Chantix Stroke and Heart Attack

Richard Burke | July 12th, 2011

Following on the heels of a recent FDA warning about Chantix heart attack in people who already have heart disease comes a new study from Johns Hopkins University that paints an even darker picture. According to the results, taking the smoking cessation drug may increase the risk of Chantix heart attack and stroke by as much as 72 percent—even in people without heart disease. This latest evidence may give patients who have suffered Chantix heart problems more incentive to file a Chantix lawsuit.

Doctor says FDA should warn about Chantix heart problems

The FDA issued a black box warning in 2009 for Chantix side effects like depression, suicidal thoughts, and violence. They also just recently required new cautionary language on Chantix labels that suggests those with cardiovascular disease weigh carefully the benefits against the risks before taking the drug. So far, however, no warning of the increased risk of Chantix heart problems has appeared on the label, though mounting evidence seems to support a case for it.

“The FDA should have already put it on their warning label,” said Dr. Sonal Singh, assistant professor of medicine at Johns Hopkins University and lead author of the study. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

Study shows risk of Chantix stroke

For this most recent study, researchers reviewed 14 other studies involving over 8,200 smokers and smokeless tobacco users, most of whom had no evidence of heart disease. Nearly 5,000 took Chantix, while about 3,300 received a placebo. Researchers then followed the study participants for 7 weeks to one year.

The analysis showed that 52 of the Chantix participants suffered cardiovascular problems, compared to only 27 of those on placebo—a risk of 72 percent when using the standard statistical method applied to evaluating multiple studies. It also showed that for every 28 smokers treated with Chantix, one additional cardiac event occurred. Singh commented that the results showed that the drug is causing the very problems it’s supposed to prevent, since those who are trying to quit smoking are usually doing so to prevent heart disease. “All smokers who take Chantix are at risk for heart attack, stroke, or other cardiovascular event,” he said.

Limitations of the study

Though the study results are obviously concerning, there were limitations. The authors themselves note that the overall number of heart problems was small, which most likely skewed risk estimates. Pfizer, the maker of Chantix, disagreed with the interpretation of the data, and stated the actual difference in cardiovascular event rates was less than one-quarter of one percent. They did go on to state that they are working with the FDA to conduct their own analysis and further evaluate the risk of Chantix heart problems.

Meanwhile, physicians and patients are on the alert. Online forums show case after case of individuals who took Chantix and experienced a stroke, and are now wondering if there is a link. As to whether or not the FDA will strengthen the warning, it seems unlikely at this time considering the study limitations. Most likely they will await further analysis, but they are paying attention.

“Dr. Singh has added to what we have seen,” said Curtis Rosenbraugh, director of the FDA’s office of drug evaluation, “and is helping to define the picture better.”