Navigation Links
Chantix associated with 72 percent increased risk of serious CV events
Date:7/4/2011

WINSTON-SALEM, N.C. July 4, 2011 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.

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."


'/>"/>

Contact: Jessica Guenzel
jguenzel@wakehealth.edu
336-716-3487
Wake Forest Baptist Medical Center
Source:Eurekalert

Related medicine news :

1. South Carolina Attorney Says Legal Options Still Available To Those Harmed By Chantix
2. Web- and phone-based counseling work well to quit smoking with Chantix
3. Smoking-Cessation Drug Chantix Linked to Heart Problems
4. Certain genetic profiles associated with recurrence-free survival for non-small cell lung cancer
5. Certain pain medications do not appear to be associated with skin cancer risk
6. News brief: ALDH associated with worse overall survival in patients with pancreatic adenocarcinoma
7. New research shows emotional impact of low sexual desire and associated distress
8. Increased HAART coverage associated with 50 percent drop
9. Pretreatment SUV associated with head and neck cancer treatment outcomes, may help decide treatment plans
10. New developments in nanotechnology tackle the 2 biggest problems associated with chemotherapy
11. MedQuist Launches EHR Integration for Dictations Associated with Template-based Clinical Documentation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/18/2017)... ... August 18, 2017 , ... August ... “Vision & Hearing,” advocating for active, healthy lifestyles and highlighting the importance of ... individuals with hearing impairments and shares the latest innovations in hearing aid technology. ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... financial consultations to communities throughout the greater DC region, is inaugurating a “New ... of rescuing local animals and training them to be companions for veterans in ...
(Date:8/18/2017)... IN (PRWEB) , ... August 18, 2017 , ... The ... communities in northwest Indiana, is campaigning in support of Campagna Academy in a charity ... to as the “Hoosier Boys’ Town of Indiana,” Campagna Academy is a nonprofit organization ...
(Date:8/18/2017)... Boca Raton, Fl (PRWEB) , ... August 18, ... ... nation’s largest network of highly trained practitioners specializing in bioidentical hormone replacement therapy ... symptoms associated with hormone imbalance and conditions of aging, such as menopause, andropause, ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... call tracking and monitoring solutions, announced today the launch of a redesigned corporate ... modern navigation and aesthetic, fully responsive design, and an enhanced search directory for ...
Breaking Medicine News(10 mins):
(Date:8/8/2017)... 2017   Second-quarter ... (GAAP) loss per share from continuing operations ... increased 16 percent to $110 million ... percent to $161 million ... continuing operations increased 8 percent to $0.93 ...
(Date:8/7/2017)... (NYSE: DPLO), the nation,s largest independent specialty pharmacy, announced financial ... unless otherwise noted, are to the quarter ended June 30, ... 2017 Highlights include: Revenue of $1,126 ... Total prescriptions dispensed of 220,000, compared to 241,000 ... Gross profit per prescription dispensed of $371, ...
(Date:8/3/2017)...  Opioid addiction and other drugs of abuse, blood ... threatening outcomes, were problems taken on directly as laboratory ... support them, met this week. This according to Kalorama ... of abuse, procalcitonin and acute kidney injury were key ... meeting in San Diego, CA. ...
Breaking Medicine Technology: