Study Indicates increased risk of heart attack, congestive heart failure and irregular heartbeats
Chantix® (varenicline tartrate), a smoking cessation drug manufactured by Pfizer, has been linked by researchers at Johns Hopkins University School of Medicine to an increased risk of "serious adverse cardiovascular events" that could include heart attack, stroke, and cardiovascular related death. The study differentiated between patients with no previous heart conditions and those with a history of heart attacks or other heart-related conditions. Other outcomes researched in the study included coronary artery disease, irregular heartbeat, congestive heart failure and more (page 2 of study).
The drug attaches to nicotine receptors in the brain, blocking the influence and "pleasurable effects of nicotine." It is also said to reduce both craving and the addictive effects of cigarettes. While the drug has helped smokers who wish to quit at double the success rate of no form of treatment, reports of the frequency and severity of harmful side effects reported in postmarketing reporting and studies have been increasing.
Approved in 2006 and now one of the most popular medications to aid smokers who wish to quit, the drug also carries one of the most stringent warning labels required by the FDA. The "black box warning" includes information about side effects including depression, suicidal thoughts or actions, unusual and sometimes hostile behavioral changes.
Researchers suggest the FDA consider a recall of the drug
The Canadian Medical Association Journal article detailed a study conducted by research at Johns Hopkins School of Medicine in Baltimore. The study researchers reviewed data and concluded through double-blind, randomized controlled studies that patients taking Chantix® were more likely to experience potentially adverse heart side effects than patients taking a placebo. The researchers mention that due to the severity and frequency of harm to patients taking the drug, the FDA should consider recalling Chantix®.
Chantix® safety concerns since the drug's approval
The side effects of Chantix® have been under scrutiny since the FDA approval in 2006. The Federal Aviation Administration banned pilots and air traffic controllers from taking the smoking cessation drug in 2008 due to concern about heart attacks and other heart problems that could cause loss of consciousness and blackouts on the job, thereby putting air travelers at risk. The CNN report indicated that truck and bus drivers are also not allowed to take the drug.
In May of 2011, France removed Champix (the European name for the drug) from the country's health plan reimbursement after questions were raised about the drug, effectively reducing the use of the drug in France.
In 2009, the LiveStrong.com website, part of cyclist Lance Armstrong's media presence, reported the potentially harmful side effects of Chantix® as it could affect athletes.
The attorneys at Sheller, P.C. are actively investigating these cases
The attorneys at Sheller, P.C. are investigating instances of heart attacks and irregular heartbeats in patients who have taken Chantix®. If you or someone you know has experienced these side effects, contact our firm for more information and guidance on your options.
CNN: Heart Risks Added to Chantix Health Concerns, July 5, 2011: http://www.cnn.com/2011/HEALTH/07/05/chantix.smoking.suicide/
Journal of the Canadian Medical Association: Risk of Serious Adverse Cardiovascular Events Associated With Varencicline: A Systematic Review and Meta-Analysis, July 4, 2011: http://www.cmaj.ca/content/early/2011/07/04/cmaj.110218
Reuters: Pfizer's quit smoking drug raises heart risks, July 4, 2011: http://www.reuters.com/article/2011/07/04/pfizer-smoking-champix-idUSL6E7I425W20110704
Fierce Pharma: Study: Pfizer's Chantix raises heart risks 72%, July 5, 2011: http://www.fiercepharma.com/story/study-pfizers-chantix-raises-heart-risks-72/2011-07-05?utm_medium=nl&utm_source=internal
Cyclist Lance Armstrong's LiveStrong website blog warns of Chantix side effects: http://www.livestrong.com/article/68870-side-effects-chantix-tablets/
New York Times: FAA Bans Antismoking Drug, Citing Side Effects, May 22, 2008: http://www.nytimes.com/2008/05/22/business/22drug.html
FAA Bans Pilots and Air Traffic Controllers From Taking Chantix, May 5, 2008: http://www.fiercepharma.com/story/chantix-side-effects-news-prompts-faa-ban/2008-05-22