Featured Research

from universities, journals, and other organizations

Popular smoking cessation drug associated with 72 percent increased risk of serious CV events, study finds

Date:
July 4, 2011
Source:
Wake Forest Baptist Medical Center
Summary:
Smoking cigarettes is a dangerous habit that many are struggling to break, but for the smokers who choose to use one of the most popular smoking cessation drugs on the market, new warnings about the risk of serious cardiovascular events are on their way.

Smoking cigarettes is a dangerous habit that many are struggling to break, but for the smokers who choose to use one of the most popular smoking cessation drugs on the market, new warnings about the risk of serious cardiovascular events are on their way.

Related Articles


A new study by researchers at Wake Forest Baptist Medical Center, in collaboration with researchers at Johns Hopkins University School of Medicine and the University of East Anglia, in the United Kingdom, shows that the use of varenicline -- marketed by Pfizer under the brand name ChantixTM -- is associated with a 72 percent increased risk of hospitalization due to a serious adverse cardiovascular (CV) event, such as heart attack or arrhythmia.

The study appears in the July 4 issue of CMAJ (the Canadian Medical Association Journal).

"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 (U.S. Food and Drug Administration)," said Curt D. Furberg, M.D., Ph.D., a professor of Public Health Sciences at Wake Forest Baptist, lead investigator on the study, and a nationally-recognized leader in drug safety research. "It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events."

Heart disease is a common cause of serious illness and death in smokers and is often a reason for people to stop smoking. Varenicline is one of the most commonly used drugs to help people quit smoking worldwide. 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 FDA recently updated the label for Chantix based on a small increased risk of cardiovascular events among smokers with heart disease.

The team of researchers sought to investigate the serious cardiac effects of varenicline in tobacco users (smokers or smokeless tobacco users) compared with placebo in clinical trials. They looked at 14 double-blind, randomized, controlled 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.

In the study, 52 of 4,908 (1.06%) participants taking varenicline had adverse events compared with 27 of 3,308 (0.82%) participants on placebo, while the number of people who died in each group was the same (seven). 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 wrote. "These increased risks of adverse cardiovascular events are seen in smokers with or without heart disease."

The researchers noted additional risks of using the drug, found in previous studies, that led to an existing box warning from the FDA -- risks of depression, agitation and suicidal thoughts.

"People should be concerned," said Sonal Singh, M.D., M.P.H., lead author on the study from Johns Hopkins University Medical Center. "They don't need Chantix to quit and this is another reason to consider avoiding Chantix altogether."

In the paper, the researchers wrote that "clinicians should carefully balance the risk of serious cardiovascular events and other serious neuropsychiatric adverse events associated with varenicline against their known benefits on smoking cessation."

"The sum of all serious adverse effects of Chantix clearly outweigh the most positive effect of the drug in my view," Furberg said. "The time has come for the FDA to withdraw the drug from the market."

Along with Furberg and Singh, co-authors on the study, funded by the National Center for Research Resources and the National Institutes of Health Roadmap for Medical Research, are: John Spangler, M.D., of Wake Forest Baptist, and Yoon K. Loke, M.D., MBBS, of the University of East Anglia.


Story Source:

The above story is based on materials provided by Wake Forest Baptist Medical Center. Note: Materials may be edited for content and length.


Journal References:

  1. Sonal Singh, Yoon K. Loke, John G. Spangler, Curt D. Furberg. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. Canadian Medical Association Journal, 2011; DOI: 10.1503/cmaj.110218
  2. J. Taylor Hays. Varenicline for smoking cessation: Is it a heartbreaker? Canadian Medical Association Journal, 2011; DOI: 10.1503/cmaj.110804

Cite This Page:

Wake Forest Baptist Medical Center. "Popular smoking cessation drug associated with 72 percent increased risk of serious CV events, study finds." ScienceDaily. ScienceDaily, 4 July 2011. <www.sciencedaily.com/releases/2011/07/110704123455.htm>.
Wake Forest Baptist Medical Center. (2011, July 4). Popular smoking cessation drug associated with 72 percent increased risk of serious CV events, study finds. ScienceDaily. Retrieved November 29, 2014 from www.sciencedaily.com/releases/2011/07/110704123455.htm
Wake Forest Baptist Medical Center. "Popular smoking cessation drug associated with 72 percent increased risk of serious CV events, study finds." ScienceDaily. www.sciencedaily.com/releases/2011/07/110704123455.htm (accessed November 29, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Saturday, November 29, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Rural India's Low-Cost Sanitary Pad Revolution

Rural India's Low-Cost Sanitary Pad Revolution

AFP (Nov. 28, 2014) — One man hopes his invention -– a machine that produces cheap sanitary pads –- will help empower Indian women. Duration: 01:51 Video provided by AFP
Powered by NewsLook.com
Research on Bats Could Help Develop Drugs Against Ebola

Research on Bats Could Help Develop Drugs Against Ebola

AFP (Nov. 28, 2014) — In Africa's only biosafety level 4 laboratory, scientists have been carrying out experiments on bats to understand how virus like Ebola are being transmitted, and how some of them resist to it. Duration: 01:18 Video provided by AFP
Powered by NewsLook.com
WHO Says Male Ebola Survivors Should Abstain From Sex

WHO Says Male Ebola Survivors Should Abstain From Sex

Newsy (Nov. 28, 2014) — WHO cites four studies that say Ebola can still be detected in semen up to 82 days after the onset of symptoms. Video provided by Newsy
Powered by NewsLook.com
Ebola Leaves Orphans Alone in Sierra Leone

Ebola Leaves Orphans Alone in Sierra Leone

AFP (Nov. 27, 2014) — The Ebola epidemic sweeping Sierra Leone is having a profound effect on the country's children, many of whom have been left without any family members to support them. Duration: 01:02 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins