Note: At the bottom of this 11-year-old post is new September 2022 information on the new Chantix cancer class action lawsuit.
Add Heart Attack and Stroke (and Cancer in 2022) to the Long List of Problems Reported by Chantix Users
With powerful evidence from a new Chantix study, heart attacks and strokes have been added to the potential risks associated with Chantix.
Chantix has been a controversial drug from day one and consumer advocates have long been pushing for its removal from the very beginning. It has been associated with many side effects, including increased risk for aggressive and suicidal behavior, diabetes, and a host of other ailments. The warning label was eventually changed on the risk of suicide and suicidal ideations (and later changed back with an acknowledgment of psychiatric events that have occurred with people on Chantix).
Some consumer complaints have been proven, some have been disproven, and the jury is still out on others. But now the data is showing something else new that Pfizer will also probably ignore: Chantix increases the risk of heart attack or stroke.
Chantix Is Big Drug
It is estimated that 46 million American adults currently smoke cigarettes. The CDC reported that the national average of adult smokers was 18.4% in 2008, down from 21% in 2004. In 2004, direct costs of smoking addiction were estimated to be greater than $96 billion per year with another $97 billion in lost productivity. Several initiatives ranging from increasing the price of cigarettes through taxes to advertising restrictions and Medicaid coverage for counseling and medications have led to a reduction in smoking prevalence.
Several medications are marketed as aids to quit smoking. One such medication is Chantix (varenicline tartrate), marketed by Pfizer. Chantix is an alternative to nicotine replacement therapies and has demonstrated greater effectiveness in studies.
Due to its effectiveness in clinical studies and the perceived absence of safety issues, Chantix received an expedited review from the FDA. The medication has been available for sale in the US since August 2006 and has received approval in other regions, including Canada and the European Union.
Chantix is sold in Canada and Europe under the name Champix. Pfizer has reported that over 7 million people have been prescribed Chantix in the United States alone and it is one of the most commonly prescribed medications for smoking cessation.
Chantix Side Effects
Initially, reported side effects included nausea, headache, difficulty sleeping, abnormal dreams, change in taste, vomiting, abdominal pain, flatulence, dystonia, muscular spasm, movement disorders, abnormal posture, and constipation.
The FDA began issuing communications in November 2007 upon receiving reports of suicidal thoughts and aggressive and erratic behavior and drowsiness. This action by the FDA was in response to a case that led to the death of a patient. In 2008 the FDA issued labeling changes that included advisories for neuropsychiatric symptoms, including suicidal thoughts or actions. As a result of these findings, the FDA continued to monitor post-market adverse effects of the smoking cessation aid.
On June 16, 2011, the FDA released the results of a clinical trial conducted in patients with cardiovascular disease who were treated with Chantix. The results demonstrated that a higher number of patients on Chantix (2.0%) had heart attacks and other cardiovascular events as compared to placebo (0.9%).
At that time the FDA recommended that the benefits of Chantix against risks in patients with cardiovascular disease needed to be taken into consideration by health care providers and stated that labeling changes would be required to address this new finding. Labeling changes were implemented in July 2011, although the FDA was aware of the possible increased risk of cardiac events at the time of an initial safety review in 2006.
A meta-analysis (a review of literature that uses statistical methods to combine evidence) by Singh et al. (2011). evaluated 14 studies with a total of 8216 participant patients. The study raised safety concerns of an increased risk of cardiovascular events with the use of Chantix. This peer-reviewed article has been criticized by authors as well as the European Medicines Agency.
The FDA and Pfizer are currently undertaking a meta-analysis to address the deficiencies of the Singh et al., publication. To date, the reported increased risk of cardiovascular events due to Chantix has resulted only in weak warning labels. This is likely due to the equation that regulatory agencies used to determine the benefit to the risk of a product. Smoking has previously been estimated to account for as many as 30% of all coronary heart disease (CHD) deaths in the United States so 1% of patients having a cardiovascular event because of a cessation product may seem like a low risk to regulatory agencies. However, when extrapolated to 7 million users, this represents a potential risk to 70,000 patients. It will be interesting to see what actions are taken once the meta-analysis is complete, and the FDA has reviewed the data in its totality.
Chantix Side Effects 2022 Update
We go back and update old posts to add in additional information.
In June 2021, Pfizer stopped making Chantix. The concern was the nitrosamines in Chantix. Nitrosamines are carcinogens that have the potential to cause bladder, stomach, kidney, lung, brain, and a host of other types of cancer.
By September 2021, Pfizer’s recall included all varenicline products.
New Chantix Class Action Lawsuit
A new Chantix class action lawsuit has been filed in Pennsylvania. The lawsuit alleges that Pfizer knew of the nitrosamine impurities long before the recall. Plaintiffs claim they bought was was ultimately worthless Chantix because of these high levels of NDMA> that was rendered worthless by elevated levels of a nitrosamine known as N-nitroso-varenicline.
N-nitrosodimethylamine, commonly known as NDMA, is an odorless, yellow chemical that many (actually, I think it is fair to say most) experts believe causes cancer.
But this Chantix lawsuit is a medical monitoring lawsuit. What is that?
The lawsuit seeks compensatory damages to pay for medical monitoring. This Chantix class action wants Pfizer to notify and alert all people exposed to nitrosamine contaminants as aforesaid of their exposure and the potential consequences. From there, the Chantix lawsuit wants Pfizer to find testing and screening for cancer. That would include the standard fare for cancer screening: physical examinations, blood tests, MRIs, CT scans and other imaging, colonoscopies, endoscopies, and so forth.
In September 2022, Pfizer field a response to the class request, asking the the US Judicial Panel on Multi-District Litigation not to create an MDL because, among other reasons, there are only 11 lawsuits. If there is a MDL class action, Pfizer believes that cases should be housed in New York.
Are Your Lawyers Handling This New Chantix Cancer Class Action Lawsuit?
We are not involved in the Chantix cancer class action lawsuit or any other Chantix lawsuit in 2022.