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chantix, heart problem risk, depression, suicidal thoughts

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Chantix Side Effects Linked to Strokes, Heart Attacks, Cardiovascular & Heart Disease Risk, Lawsuits being Evaluated

Chantix, Zyban Side Effects include: Cardiovascular, Stroke, Heart Attack, Heart Disease Risk, Depression, Suicidal Thoughts, Hostility, Anxiety, Irritability. Potential Lawsuits

New Chantix Side Effects Study Cites Increased Cardiovascular, Heart Attack, Strokes and Heart Disease Risk

Chantix, Smoking Cessation Drug

A published report states that users of the smoking cessation drug Varenicline, brand name Chantix, has been linked to a small but statistically significant increased risk of cardiovascular events. The study was conducted by CMAJ suggests that 1 in every 28 patients receiving Chantix would experience a serious cardiovascular risk such as a stroke or heart attack.

If you take Chantix or Zyban in an effort to quit smoking and have experienced psychiatric problems, you should know that these drugs could be to blame. Additionally, new evidence suggests that Chantix and Zyban have been linked to serious cardiovascular, heart disease, stroke and heart attack risk, as well as, mental health events including changes in behavior, depression, hostility, and suicidal thoughts.

The mental health side effects have been so serious that in July 2009, the Food & Drug Administration (FDA) mandated that a Black Box Warning - the agency's most serious safety notice - be added to the label of Chantix and Zyban highlighting their association with mental health problems. The cardiovascular risks prompted the Food & Drug Administration to issue a warning to physicians in June 2011 that users of Chantix or Zyban face an increased risk of heart problems such as strokes and heart attacks.

parker Waichman is currently investigating Chantix and Zyban lawsuits on behalf of people who have suffered serious mental health problems and cardiovascular problems as a result of these medications. Since Chantix and Zyban did not come with stronger warnings about their psychiatric or cardiovascular side effects, it is possible that many users have no idea that the mental health problems or heart disease problems they experienced may have been caused by these drugs.

Chantix is a smoking cessation medication marketed by Pfizer, Inc. that was approved by the FDA in 2006. Chantix works by blocking nicotine receptors, thereby reducing cravings for and decreases the pleasurable effects of cigarettes and other tobacco products. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It is an alternative to other smoking cessation drugs and nicotine replacement therapy.

Shortly after it was introduced to the market, some Chantix patients reported that they had experienced strange side effects, including erratic behavior, suicidal thoughts and depression, while taking the drug. In November 2007, the FDA announced that it had begun a Chantix safety review because of these reports.

In 2008, Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, wanted the FDA to go further and highlight the Chantix suicide risk with a Black Box Warning.

Zyban, manufactured by GlaxoSmithKline, was originally marketed as an antidepressant under the name Wellbutrin. In 1997, the FDA approved Zyban to be used as a quit smoking aid, and since then, it has become a popular method to help smokers kick the habit. Zyban, when used in combination with other nicotine replacement therapies (NRT's), such as the nicotine patch or nicotine gum, increases the chances for long term success with smoking cessation.

FDA Warning For Chantix and Zyban

FDA Warning For Chantix and Zyban

In July 2009, the FDA announced it had mandated a Black Box Warning for the labeling of Chantix and Zyban to highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

The FDAs request for the additional warnings was based on a review of reports submitted to the agency. Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. According to media reports, the FDA had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban.

In many cases, the FDA said the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal, the FDA said. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking, the FDA said.

In addition to the Boxed Warning, the FDA also requested more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using Chantix or Zyban.

Legal Help for Victims of Chantix or Zyban Side Effects

If you or someone you love has used Chantix or Zyban to quit smoking, and experienced serious mental health problems, cardiovascular, stroke and heart disease problems, you may be eligible to file a Chantix or Zyban lawsuit. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) as soon as possible to discuss your case with one of our Chantix or Zyban injury lawyers.

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Pfizer Documents over Chantix should be Unsealed, Experts Say

Sep 18, 2014
Pfizer’s internal documents regarding the antismoking drug Chantix should be unsealed before the U.S. Food and Drug Administration (FDA) holds a meeting next month to discuss whether or not the drug should carry a warning about suicide, said two expert witnesses in the multidistrict litigation. According to National Law Journal, Dr. Joseph Glenmullen, an expert causation witness for party suing over the drug, and drug-safety researcher, Thomas Moore, both expressed that the...

Chantix Psychiatric Side Effects Warnings Need Strengthened, Scientists Say

Nov 3, 2011 | Parker Waichman LLP
A new study has found that Chantix has been named in more suicidal behavior and depression reports to the U.S. Food and Drug Administration (FDA) than any other stop-smoking remedy.   While Chantix has been named in 90 percent of such reports since 1998, Zyban, an antidepressant used to help people quit, accounted for only 7 percent of suicide and depression report, while nicotine replacement products were named in only 3 percent. This new study, which appears in the Nov. 2 edition...

Chantix Recall Urged After Study Finds Significant Heart Risks

Jul 5, 2011 | Parker Waichman LLP
A Chantix researcher is calling on the U.S. Food & Drug Administration (FDA) to pull the controversial stop-smoking drug from the market after a study he co-authored showed that taking Chantix increased the risk of heart attacks, strokes and other cardiovascular events by as much as 72 percent."The sum of all serious adverse effects of Chantix clearly outweighs the most positive effect of the drug," Dr. Curt D. Furberg, a Wake Forest medical professor, said according to The Wall Street...

Chantix Faces Canadian Safety Review

Jun 28, 2011 | Parker Waichman LLP
A week after the U.S. Food & Drug Administration (FDA) announced a label change for Chantix after a study linked it to a higher risk of heart problems in people with pre-existing cardiovascular disease, regulators in Canada - where the drug is sold as Champix - said they are conducting their own safety review.  The study that prompted both agencies to act assessed Chantix for smoking cessation in 700 patients aged 35 to 75 years with stable, documented cardiovascular disease (other...

Chantix May be Risky for Heart Disease Patients, FDA Says

Jun 16, 2011 | Parker Waichman LLP
The Chantix label is being updated to warn that it may cause heart problems, including heart attacks, in people with pre-existing cardiovascular disease.  The agency is also requiring Pfizer, the maker of Chantix, to conduct an analysis of earlier clinical trials to evaluate the drug’s heart side effects.The new Chantix heart warning will be included in the "Warnings and Precautions" section of the drug’s label.  Chantix, which was approved in 2006 for smoking-cessation,...

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