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Chantix® (varenicline)

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 meta-analysis of 14 clinical trials found that heart trouble resulting in hospitalization, disability or death was 72% more likely in patients using the drug rather than placebo" July 5, 2011 "Fierce Pharma" pharmaceutical industry daily report

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.

Sheller, P.C. attorneys are investigating potentially harmful side effects involving serious adverse cardiac events as described in the study. It is important that you learn your legal options at your earliest opportunity - contact our firm at 800-883-2299 or fill out the confidential inquiry form below

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®.

"People should be concerned. They do not need Chantix to quit and this is another reason to consider avoiding Chantix altogether. People want to quit smoking to reduce the risk of cardiovascular disease, but in this case they are taking a drug that increases the risk for the very problems they are trying to avoid" stated Sonal Singh of Johns Hopkins University School of Medicine, lead researcher of the study in a Reuters article.

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.

Related information:

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

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Related Media

On July 5, 2011 CNN and other media reported on a sudy by researchers at the Johns Hopkins School of Medicine and published in a medical journal that said the smoking cessation drug Chantix® is linked to an increased in heart attacks and irregular heartbeats.

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