5 July 2011
Medicos want Champix banned
by Kate Melville
An international team of researchers have called for the smoking cessation drug varenicline (marketed as Champix in Europe and Chantix in the US) to be withdrawn from the market after alarming findings linking the drug to heart attack and stroke.
The researchers, from Wake Forest Baptist Medical Center, Johns Hopkins University School of Medicine and the University of East Anglia (UK), say that varenicline is associated with a 72 percent increased risk of hospitalization due to a serious cardiovascular event, such as heart attack, arrhythmia or stroke. The findings appear in the Canadian Medical Association Journal.
Varenicline use has previously been linked to depression, agitation and suicidal thoughts. "We have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse effects reported to the FDA," said Curt D. Furberg, a professor of Public Health Sciences at Wake Forest Baptist and lead investigator on the study. "It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events."
When varenicline was launched in 2006, the FDA safety reviewers reported that existing data indicated it could raise the risk of adverse cardiac events. The new study sought to investigate the serious cardiac effects of varenicline in tobacco users (smokers or smokeless tobacco users) compared with placebo in clinical trials.
In the study, 52 of 4,908 (1.06 percent) participants taking varenicline had adverse events compared with 27 of 3,308 (0.82 percent) participants on placebo. The majority of study participants were men and averaged less than 45 years of age.
"Among tobacco users varenicline use was associated with a significantly increased risk of serious adverse cardiovascular events greater than 72 percent," the researchers note. "These increased risks of adverse cardiovascular events are seen in smokers with or without heart disease."
"The sum of all serious adverse effects of Chantix clearly outweigh the most positive effect of the drug in my view," Furberg concluded. "The time has come for the FDA to withdraw the drug from the market."