(dailyRx News) Cigarette smokers may be ready to kick their habit, but a popular smoking cessation drug may only add health risks. A new study indicates that Chantix (varenicline) may come with a heightened risk of serious heart problems.
The research by Wake Forest Baptist Medical Center in collaboration with Johns Hopkins University School of Medicine and the University of East Anglia in the United Kingdom revealed that Chantix is linked to a 72 percent increased risk of hospitalization from a serious cardiovascular event such as a heart attack or arrhythmia. The drug is marketed by Pfizer.
Risk of heart disease is a major reason that smokers decide to quit. Chantix was approved in 2006, and U.S. Food and Drug Administration officials just recently updated the drug's label adding that Chantix could cause a small increased risk of cardiovascular events among smokers with heart disease.
Dr. Curt D. Furberg, M.D., Ph.D., a professor of public health sciences at Wake Forest Baptist and lead investigator of the study, said researchers have known for years that Chantix is one of the most dangerous drugs on the U.S. market based on the number of serious adverse side effects reported to the FDA.
Before the study found that the drug causes the added heart risk, it already had been identified as causing numerous serious side effects including loss of consciousness, visual disturbances, suicides, violence and depression.
The research included 14 double-blind, randomized, controlled clinical trials. More than 8,200 patients participated -- nearly 5,000 of which were on varenicline and the remainder took a placebo. All but one trial excluded those with a history of heart disease, and none of the studies followed participants for longer than one year.
During the course of the study 52 of 4,908 participants taking varenicline had adverse events compared with 27 of 3,308 who were taking the placebo. Seven died in each group. Most study participants were men and averaged less than 45 years of age. The increased risk of heart disease was seen in smokers with and without cardiovascular disease.
Researchers have called for removal of the drug from the market, and suggest that smokers try quitting without using the drug. The findings were published in the Canadian Medical Association Journal.