Chantix Study Sees Significant Increase in Heart Risks

People taking <"">Chantix (varenicline), Pfizer Inc.’s controversial stop-smoking drug, face a much higher risk of heart attacks, strokes and other serious cardiovascular events, according to a new study from researchers at Johns Hopkins University and Wake Forest Baptist Medical Center. The new findings add to the already-long list of safety woes that have plagued Chantix for years, and could result in even more safety warnings being added to the Chantix label.

The Wake Forest/Johns Hopkins study involved a meta-analysis of 14 earlier Chantix trials that included more than 8,200 patients (4,908 people on varenicline and 3,308 taking placebos). All trials, except one, excluded people with a history of heart disease, and none of the studies followed participants for longer than one year. The majority of study participants were men and averaged less than 45 year.

In the study, 52 of 4,908 (1.06%) participants taking Chantix had an adverse cardiac event compared with 27 of 3,308 (0.82%) participants on placebo. Seven in each group experienced a fatal event. The study authors concluded that doctors could expect to get one extra cardiac event associated with Chantix for every 28 smokers they treated with the drug. The study also found that people with no signs of heart problems possibly face the highest risks from Chantix

“Among tobacco users varenicline use was associated with a significantly increased risk of serious adverse cardiovascular events greater than 72 percent,” the researchers wrote. “These increased risks of adverse cardiovascular events are seen in smokers with or without heart disease.”

The study is published in the Canadian Medical Journal.

Since being approved by the U.S. Food & Drug Administration (FDA) in 2006, Chantix has been prescribed to 13 million people. The drug has long been controversial because of its association with psychiatric side effects, including suicidal thoughts and behavior. In 2009, the FDA announced that a Boxed Warning would be added to the Chantix label because of such problems. The drug has since been named in numerous personal injury lawsuits.

According to a New York Times report, the findings of this latest study have prompted one of its authors to ask that the FDA recall Chantix from the U.S. market. Dr. Curt D. Furberg, a Wake Forest medical professor, said that because of the number of serious side effects, its risks outweigh its benefits.

“It piles up,” Furberg told the Times. “I don’t see how the FDA can leave Chantix on the market.”

Dr. Sonal Singh, assistant professor of medicine at Johns Hopkins University and co-author of the study, told the Times that Pfizer and the FDA haven’t pursued signs of cardiovascular risk since Chantix was approved.

“The FDA should have already put it on their warning label,” Dr. Singh said. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

Last month, the FDA did take some action on Chantix heart risks by warning that people with pre-existing heart problems could face a higher risk of cardiovascular events if they take the drug. The information, which was added to the “Warnings and Precautions” section of the Chantix label, was based on a study that assessed Chantix for smoking cessation in 700 patients aged 35 to 75 years with stable, documented cardiovascular disease.

According to Bloomberg News report, Curtis Rosenbraugh, director of the FDA’s office of drug evaluation, said the agency is investigating this latest Chantix study and may consider additional warnings.

“I’m not sure until we can further evaluate the study whether it’s going to change the label or not, but I can assure you this is something we’re very concerned about and are taking very seriously,” Rosenbraugh said.

This entry was posted in Chantix, Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.