Smoking-related diseases claim more than 480,000 lives in the United States every year, which accounts for about one out of every five deaths among Americans. According to the CDC, cigarette smoking harms nearly every organ in the body, leading to disability and potentially fatal diseases, like lung cancer, chronic obstructive pulmonary disease (COPD), heart disease, and stroke. Unfortunately, many smokers who want to quit smoking to protect their health turn to prescription smoking cessation drugs like Chantix, which has been linked to a number of serious and potentially life-threatening side effects, including cancer, heart attack, psychosis, suicide, suicidal thoughts, and stroke. If you took Chantix to quit smoking, and you have been diagnosed with cancer or suffered another serious side effect, contact our consumer advocates today. We can put you in touch with an experienced Chantix injury attorney who can help you determine whether you qualify for a Chantix lawsuit.
The nicotine found in cigarettes and other tobacco products is highly addictive, which makes it difficult for smokers who want to quit to do so successfully. That is why smoking cessation drugs like Chantix have become so popular among smokers. However, there are alternatives to Chantix that can reduce nicotine cravings and help cigarette smokers quit smoking without the risk of harmful side effects associated with Chantix. The next time you find yourself reaching for a cigarette, these alternatives to Chantix may help you resist your nicotine cravings in a safer way:
Chantix (varenicline) is a prescription medication used in the treatment of smoking and nicotine addiction. Chantix was introduced by Pfizer and garnered approval from the FDA in 2006 via priority review. The drug is meant to be taken short-term for 12 to 24 weeks to help adults 18 years old and older quit smoking. When you smoke a cigarette, nicotine attaches to nicotine receptors in the brain and dopamine is released, which triggers feelings of pleasure. When these dopamine levels drop, you crave another cigarette, and the cycle continues. Chantix is believed to help with smoking cessation by attaching to nicotine receptors in the brain so nicotine can’t. Dopamine is still released, but not as much as with nicotine, and this is believed to help reduce cravings for and decrease the pleasurable effects of cigarettes.
The safety and efficacy of Chantix has been fiercely debated since 2007, when concerns were initially raised about the long-term safety of the smoking cessation drug and its link to adverse cardiovascular events in users. Since that time, there have been more than a dozen warnings and safety communications issued by federal regulators in connection with Chantix and the potential risk of cardiovascular problems, adverse psychological events, and other serious side effects in users. Among the injuries associated with Chantix use are:
Despite the possible smoking cessation benefits of Chantix, new side effect data links the drug to serious adverse events in users, including an increased risk of cancer due to the unexpected presence of the carcinogen N-nitroso-varenicline in Chantix. Pfizer was forced to recall all lots of Chantix 0.5-mg and 1-mg nationwide in September 2021, after testing uncovered unacceptable levels of N-nitroso-varenicline, a nitrosamine impurity associated with a potential increased cancer risk in humans. Other potentially harmful nitrosamines that have led to widespread recalls of popular pharmaceutical drug products in recent years include N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). The discovery of these cancer-causing substances in widely used heartburn drugs like Zantac, blood pressure medications like valsartan and losartan, and diabetes drugs like metformin, have led to thousands of lawsuits filed against the drug manufacturers by patients who say unexpected exposure to nitrosamines in the drugs caused them to develop cancer.
In a press release issued on September 16, 2021, Pfizer warned that “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans,” though the company tempered that claim by stating that “there is no immediate risk to patients taking this medication.” Pfizer claimed in the recall announcement that it is undertaking this “precautionary measure” because alternative Chantix suppliers have been approved in the U.S.
In addition to a possible increased risk of cancer, there is also evidence that Chantix use may be tied to an increased risk of mood swings, suicide, and suicide ideation, among other neuropsychiatric side effects. By the end of 2007, at which point Chantix had been available for just one year, the smoking cessation drug already accounted for 988 serious injuries reported to the FDA, more than any other drug on the market at that time. In an early communication about an ongoing safety review of Chantix issued in November 2007, the FDA warned that a preliminary assessment of postmarketing cases submitted to the FDA by Pfizer revealed that many cases of suicidal ideation and suicidal behavior in Chantix users involved “new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.”
In 2008, the Institute for Safe Medication Practices (ISMP) published its findings regarding Chantix side effects, indicating that “Varenicline is suspected in various adverse drug event reports of causing a wide spectrum of injuries, including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide.” The ISMP report led the FDA to order pilots with the Federal Aviation Administration to stop taking Chantix. Shortly after, the Federal Motor Carrier Safety Administration, which oversees the trucking and bus industry, issued a similar Chantix ban for its commercial drivers. Concerned about these serious Chantix side effects, the Department of Defense also prohibited certain weapons and aircraft personnel from using Chantix.
Studies conducted over the past decade or more suggest that Chantix users may also be at risk for heart attacks, strokes, and other adverse cardiovascular events. In fact, researchers have found that Chantix use may increase a person’s heart attack risk by up to 72%. This is of particular concern for patients with a history of heart attacks, who may be more likely to suffer a second or subsequent heart attack event while taking Chantix. However, researchers warn that the heightened heart attack risk is present even in patients without cardiovascular disease.
August 2021 – A Chantix class action lawsuit is filed in New York against Pfizer, alleging that the presence of cancer-causing impurities in Chantix makes the smoking cessation drug unreasonably dangerous for users.
July 2013 – A settlement agreement is finalized, resolving nearly 700 Chantix claims filed against Pfizer over the company’s alleged failure to provide Chantix users with proper warnings about the potential psychological side effects of the smoking cessation drug.
March 2013 – The judge overseeing the Chantix multidistrict litigation (MDL) orders mediation for all Chantix cases that remain unresolved.
March 2013 – Pfizer announces that settlement agreements have been reached with plaintiffs in about 80% of the more than 2,500 Chantix lawsuits filed over serious psychological side effects like suicide, attempted suicide, and unexpected aggressive behavior, with an estimated cost of $273 million.
January 2013 – Pfizer settles a lawsuit filed over the company’s alleged failure to warn about the risk of psychological side effects in Chantix users, days before the trial is scheduled to begin.
October 2012 – Pfizer agrees to settle a Chantix lawsuit brought by the family of a man who committed suicide while taking the medication to quit smoking.
September 2012 – The federal judge overseeing the Chantix MDL allows the plaintiff in the first Chantix suicide lawsuit to go before a jury to pursue punitive damages against Pfizer.
May 2012 – Pfizer asks the court to dismiss Chantix lawsuits filed by plaintiffs who suffered psychiatric side effects associated with the smoking cessation drug after a black box warning was added to the drug label in 2009.
March 2012 – The first trial dates are set for Chantix lawsuits filed in federal courts across the country over suicide and other psychological side effects allegedly linked to the smoking cessation drug.
September 2021 – The first generic version of Chantix (varenicline) is launched by Endo Pharmaceuticals and will be distributed by its Par Pharmaceutical subsidiary.
September 2021 – Pfizer issues a recall for all lots of Chantix 0.5 mg and 1 mg tablets nationwide “due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit.”
August 2021 – Amid continuing concerns about the potential side effects of exposure to N-nitroso-varenicline in Chantix, Pfizer expands its Chantix recall to include additional lots of the smoking cessation drug.
July 2021 – Pfizer recalls a dozen lots of Chantix due to concerns about the N-nitroso-varenicline impurity.
June 2021 – Pfizer stops global distribution of Chantix, pending further testing, due to the presence of unacceptable levels of the carcinogen N-nitroso-varenicline above the intake limit established by the FDA.
December 2016 – Based on the results of a clinical trial studying the possible serious neuropsychiatric side effects of Chantix, the FDA removes the boxed warning for serious mental health side effects from the Chantix label.
March 2015 – A safety announcement from the FDA warns that Chantix can change the way people react to alcohol and may also cause seizures in users. The Chantix label is updated to reflect these potential risks.
September 2014 – A review of FDA adverse event reports conducted by the ISMP finds that Chantix is associated with more reports of suicidal thoughts and behaviors than any other drug sold in the U.S.
December 2012 – Based on the results of a large meta-analysis of Chantix clinical trials designed to assess the cardiovascular safety of the smoking cessation drug, the FDA notifies the public that “A higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) was observed in patients using Chantix compared to placebo.”
October 2011 – After reviewing the results of two FDA-sponsored epidemiological studies assessing the risk of neuropsychiatric adverse events with Chantix, the FDA reports that neither study found a difference in the risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT). However, the FDA admits that “both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events.”
July 2011 – The FDA approves an updated label for Chantix regarding the use of the smoking cessation drug in patients with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD).
June 2011 – The FDA issues a warning indicating that Chantix may increase the risk of heart attacks, strokes, and other cardiovascular side effects in patients with cardiovascular disease.
July 2009 – The FDA requires Chantix to carry a black box warning highlighting the potential connection between Chantix and adverse psychological effects, such as suicide, depression, mood swings, and aggression.
May 2008 – The Institute for Safe Medication Practices (ISMP) publishes its findings regarding Chantix side effects, linking the smoking cessation drug to a range of side effects, including serious accidents and falls, severe skin reactions, potentially lethal cardiac rhythm disturbances, seizures, acute myocardial infarction, diabetes, aggression, psychosis, and suicide.
February 2008 – A public health advisory from the FDA warns that it is “increasingly likely” that there may be an association between Chantix and serious neuropsychiatric symptoms in users. At the FDA’s request, Pfizer updates the prescribing information for Chantix to include warnings about the potential for the smoking cessation drug to cause severe changes in mood and behavior.
November 2007 – The FDA warns the public for the first time about the potential connection between Chantix and severe changes in mood and behavior, including an increased risk of suicidal thoughts and aggressive and erratic behavior. Information about these possible side effects is added to the Chantix label.
May 2018 – A study of Chantix in adolescent smokers 12-19 years of age finds a risk of adverse events similar to those seen in adult users. These include nausea, vomiting, headache, agitation, and abnormal dreams.
December 2017 – Research published in the American Journal of Respiratory and Critical Care Medicine finds that varenicline (Chantix) appears to be associated with an increased risk of cardiovascular events.
June 2016 – Pfizer releases the results of a Chantix clinical trial in The Lancet, claiming that the drug does not increase the risk of suicide. However, upon reviewing the collected data, FDA staffers point out a number of problems with the clinical trial. These problems include inconsistent assessment of the severity of side effects experienced by Chantix users, inconsistent handling of cases involving suicidal behavior, and downgraded side effects (i.e., anger coded as irritability).
December 2012 – A large meta-analysis of clinical trials comparing patients taking Chantix to patients treated with a placebo finds “A higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke)” in patients taking Chantix.
June 2012 – A report from the ISMP indicates that Chantix and an epilepsy drug called Lamictal are associated with more than 200 reported cases of severe skin reactions known as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), including seven patient deaths.
November 2011 – The journal PLoS One publishes a study analyzing thousands of reports of depression and suicidal behavior in people taking Chantix, Zyban or nicotine replacement drugs for smoking cessation reported to the FDA between 1998 and 2010. According to the study authors, the psychological risks of Chantix exceed those associated with either of the other two treatments. “The dramatic increase of [psychological] symptoms is caused by the drug. Among all the treatments we have for smoking cessation, Chantix is the worst.”
September 2011 – Research published in the Canadian Medical Association Journal finds a significantly increased risk of serious adverse cardiovascular events in patients taking Chantix as a smoking cessation aid compared to those taking a placebo. According to the study findings, Chantix users may face a 72% increased risk of heart attack, stroke, and other serious heart-related side effects.
June 2011 – The results of a randomized clinical trial of 700 smokers with cardiovascular disease treated with Chantix or a placebo show that cardiovascular adverse events, like heart attacks, are reported more frequently in patients who take Chantix compared to patients who take a placebo.
May 2008 – Researchers from the ISMP and Wake Forest University publish a study highlighting close to 1,000 adverse event reports associated with Chantix use, including dizziness, blurred vision, loss of consciousness, and confusion. “These data provide a strong signal that the risks of varenicline treatment have been underestimated and show that a wide spectrum of serious injuries are being reported in large numbers,” the researchers state.
March 2000 – Research published in the British Medical Journal concludes that “Exposure to high concentrations of nitrosamines is associated with increased mortality from cancers of the oesophagus, oral cavity, and pharynx, but not with increased mortality from cancers of the stomach or lung.”
More than 13 million people have been prescribed Chantix to quit smoking, despite more than a decade’s worth of studies and adverse event reports linking the smoking cessation drug to a wide spectrum of serious side effects. Unfortunately, consumers taking Chantix to quit smoking had no knowledge of the serious side effects associated with the drug, which may outweigh its possible smoking cessation benefits. And, because they were not properly warned about the potential adverse effects of Chantix treatment, patients who experienced cancer, suicidal thoughts, sudden changes in mood or behavior, or other serious side effects while taking the medication had no idea that it could be responsible for their injuries. Chantix lawsuits against Pfizer allege that the company:
If you or a loved one has suffered serious injuries which you believe to be associated with the smoking cessation drug Chantix, you should speak to an experienced Chantix attorney as soon as possible to discuss your legal options. You may be entitled to damages, which you can pursue by filing a Chantix injury lawsuit against Pfizer. Pharmaceutical companies like Pfizer are responsible for the safety of their medications and should be held accountable for any adverse side effects sustained by consumers. With the help of a qualified Chantix injury lawyer, victims of alleged Chantix side effects and their loved ones can protect their rights and pursue the compensation they deserve.