Chantix was introduced to the U.S. market as the most successful smoking cessation drug for those who wish to quit their dangerous smoking addiction.
Did Chantix accomplish what it promised? Is it safe and effective? Let’s find the answers here.
Though Chantix helped many people quit their smoking, it came with its share of side effects too. Chantix lawsuits, which started haunting its manufacturer soon after its approval proved that it can lead to psychiatric issues in the users.
This article dives deep into Chantix and the Chantix lawsuits that haunt its maker Pfizer in the recent past.
Before plunging into the Chantix side effects, which led to the legal battle, let’s know some basic statistics on smoking and the need to break free from smoking addiction.
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Tobacco Addiction Statistics
Tobacco addiction is considered one of the worst ongoing epidemic around the world. According to the recent update of the World Health Organization on July 31, 2023, every year, smoking addiction claims the lives of more than 8 million people across countries. A horrifying reality is that this includes the lives of 1.3 million non-smokers too (passive smoking).
As of 2023, around 30 million U.S people including 3.08 million school students are addicted to smoking, says the Centers for Disease Control and Prevention (CDC). However, according to Gallup, there is a steep decline in U.S. smokers (only 12% in 2022) in the recent years when compared to the past. Thanks to the smoking-cessation methods like- nicotine gums, patches, drugs, nasal sprays and other nicotine replacement therapies.
One such drug that promises a smoke-free life is Chantix.
What is Chantix? – Have a Closer Look
Chantix is the brand name for an anti-smoking drug, varenicline. It is a “selective alpha4-beta2 neuronal nicotinic acetylcholine receptor partial agonist,” says the NCBI. It is said to compress the feeling of smoking satisfaction and restrict the withdrawal symptoms after one quits smoking.
Chantix is made and marketed by Pfizer. It contains varenicline tartrate. Chantix got the FDA approval in 2006 and sore to fame as the effective solution for smoking cessation as it is nicotine-free. Though other nicotine replacement therapies like nicotine gums, patches and nasal sprays are there, Chantix is considered to be more effective.
Chantix (varenicline tartrate) is also used to treat dry eye disease by prompting tear production.
How does Chantix work on smokers?
When people smoke cigarettes, the nicotine in them prompt their brain to release a hormone named dopamine, which is known to lift the mood of the smokers. When these smokers start taking Chantix, within a week, it overpowers the brain cells from receiving nicotine. This would cause a drop in dopamine release hindering the pleasure the smokers get from smoking and controls the nicotine cravings at the same time.
According to the Journal of the American Medical Association (JAMA), when compared to its placebo drug, Chantix worked better in helping 44% people quit smoking. The placebo was helpful to only 17.7% people.
How long does Chantix stay in your system?
According to the FDA, it would take 24 hours (half-life) for the kidney to eliminate half of the substance from the body.
FDA’s Black Box Warning on Chantix
Following the post marketing case reports and events reported to the FDA’s Adverse Event Reporting System (AERS), on the suicidal tendency found in people who took varenicline, the FDA undertook two safety assessments. The study conducted in 2008 concluded that varenicline might worsen the existing neuropsychiatric disorders in people.
The assessments revealed that Chantix contained 155-474 ppm of nitrosamine, which is very high.
In July 2009, the FDA insisted Pfizer to add a black box warning on Chantix to warn the neuropsychiatric symptoms risk in people who used the drug.
(The FDA gives black box warnings on products, when they are reported to cause adverse side effects to warn the users. The next step taken by the FDA would be a product recall.)
See what the warning label conveys:
In 2011, the FDA insisted on adding cardiovascular risks like heart attack and stroke in Chantix label, after reviewing a trial done on 700 smokers. It warned the people with cardio vascular disease to avoid taking Chantix as it would heighten the risk of cardiovascular related adverse events.
After the publication of studies done on the neuropsychiatric risks by the NCBI and other researchers afterwards, the European Medicines Agency (EMA) removed the black triangle warning on the neuropsychiatric risk from Chantix in April 2016.
According to the Physician’s First Watch, it was after a study conducted on around 8000 patients with and without psychiatric issues, the FDA considered removing the black box warning on Chantix in December 2016. Prior to that an advisory panel too supported the removal.
Side Effects of Chantix
The most common Chantix side effects include
- Abnormal posture
- Constipation
- Headache
- Involuntary (unintended) muscle contractions
- Nausea
- Sleep issues
- Unusual dreams
- Vomiting
Adverse Varenicline side effects include:
- Allergic reactions like swelling in face, tongue and throat
- Angina pectoris Irecurring chest pain due to improper blood circulation to heart
- Breathing issues
- Memory loss
- Mood changes
- Seizure
- Suicidal tendency
- Symptoms of heart attack or stroke
- Vision changes
It is said that the nitrosamines in Chantix is the cause of these side effects.
Are Nitrosamines dangerous?
Nitrosamines are not dangerous as you think. They are naturally found in many food products. However, when the intake of nitrosamine becomes high and consumed for a prolonged period, it may lead to dangerous side effects like cancer.
It is not scientifically proved yet that it would cause cancer in human beings. However, studies conducted in animals proved that they are carcinogenic in nature. They have created tumors in liver, kidneys and lungs in rodents.
The nitrosamine found in Chantix, N-nitroso-varenicline is different from the N-nitrosodimethylamine (NDMA) used in drugs like ranitidine.
N-nitroso-varenicline, when taken in limited quantity (FDA limit of 37 nano grams/day), would not cause much health risks. When it goes beyond that limit and the human body is exposed to it for a longer period, it could turn out to be carcinogenic as most of the other nitrosamines.
Chantix Recall
In June 2021, Pfizer recalled a few selected lots of Chantix voluntarily due to the elevated presence of nitrosamine levels. Later in July 2021, Pfizer completely stopped the production of Chantix.
In July 2021, the FDA had announced that
This is because the FDA considered that the benefits of the drug outweighed the risks.
On September 16, 2021, Pfizer expanded its nationwide recall including all lots of Chantix 0.5 mg and 1 mg pills.
They stated that the recall was expanded as the long-term consumption of N-nitroso-varenicline might have a potential cancer risk in human beings. However, there would be no immediate cancer risk to patients taking this medication as it was meant for a short term use to stop smoking.
Is Chantix still on the market/ is Chantix still available? No, Chantix was completely recalled by Pfizer. However, the generic versions of varenicline had replaced Chantix in the market soon.
In August 2021, the FDA approved the distribution of the Canadian generic version of varenicline- Apo-varenicline (varenicline tartrate) in the U.S. It contained N-nitroso-varenicline levels within the FDA’s daily intake limit.
In May 2022, the FDA updated that it was confident that the manufacturers would only produce varenicline with N-nitroso-varenicline impurity below the agency’s accepted daily intake limit of 37ng.
Evolution of Chantix Lawsuits
Linda Collins filed the first ever known Chantix lawsuit against Pfizer in July 2008 in the U.S. District Court in Indianapolis. Her husband, David Collins started taking Chantix in October 2007 to quit smoking. However, he committed suicide by shooting himself in January 2008, despite having any pre-history of psychiatric illness. She alleged that Pfizer failed to warn the users of the drug’s side effect, which led to the death of her husband.
The second Chantix lawsuit was filed by Brian Kline in the District Court for the Eastern District of Pennsylvania. After taking the drug, he had a violent psychosis episode and ended up being admitted at the hospital.
Soon five more Chantix lawsuits were filed in the Supreme Court of New York, in New York County on behalf of the people who committed suicide or made self-injuries after using Chantix. Many other lawsuits followed these on the same grounds.
In October, 2009, all the Chantix lawsuits were consolidated into MDL 2092 in the District Court of Alabama under Judge Inge Prytz Johnson. In December 2014, MDL 2092 was terminated.
In October 2012, Pfizer settled the case filed by the widow of Mark Whitely, whose husband committed suicide after using Chantix. The Chantix lawsuit settlement amount in this case was kept confidential. Her case was supposed to go for trial as the first case.
In January 2013, Pfizer made another secret Chantix settlement with Billy G. Bedsole, Jr., for causing psychiatric issues and suicidal thoughts. This case should have been the first bellwether case after Whiltely’s case was settled. However, Pfizer settled it before going to trial.
In 2013, Pfizer settled more than 80% of 2,700 Chantix lawsuits for a $273 million and allocated another $15 million to settle the rest of Chantix lawsuits alleging adverse side effects.
That was not the end of Chantix lawsuits.
On July 7, 2020, Vasiliki Vardouniotis pursued a Chantix lawsuit against Pfizer for causing her the below injuries:
“The plaintiff alleges that, at some point after she began taking Chantix, she experienced a number of injuries, including chronic pain in her spine, abdomen, and hips; dystonia and muscular spasms; persistent dystonic tic; spinal disk bulges; arthritic changes in her neck; cervical spinal stenosis; abnormal straightening of the cervical spinal canal; limping upon ambulation; difficulty lifting items; persistent exhaustion; labored breathing; depression; and anxiety.”
According to the casetext.com, the plaintiff filed this lawsuit under different causes of actions like:
“(1) negligence; (2) breach of express warranty; (3) breach of implied warranty; (4) fraudulent misrepresentation; (5) fraudulent concealment; (6) reckless and/or negligent misrepresentation and concealment; (7) gross negligence; (8) willful, wanton, and malicious conduct; and (9) unjust enrichment.” (Vardouniotis v. Pfizer, Inc., Index No. 152029/2019, 2 (N.Y. Sup. Ct. 2020).)
On August 12, 2021, plaintiff Rosalyn Harris filed a lawsuit against Pfizer. Later it was amended on November 10, 2021 to include Mary Allen as another plaintiff. Both of them purchased the Chantix pills prior to the recall and had been using it for 1 to 2 years. Their claim did not allege any injuries but claimed for their monetary damages. In February 16, 2022, this Chantix recall lawsuit was dismissed by the District Judge Denise Cote.
On September 13, 2022, a Chantix class action lawsuit was filed in Pennsylvania Eastern District Court by Teresa Baptiste. Judge Wendy Beetlestone was assigned to handle the claim.
This Chantix lawsuit 2022 alleged that Pfizer sold Chantix, a drug containing carcinogens to people. The plaintiff accused Pfizer that its drug was adulterated, misbranded and had not followed the Current Good Manufacturing Practices (CGMP) laid out by the FDA.
Many people started filing Chantix cancer lawsuits against Pfizer. On December 22, 2022, all the Chantix cancer claims were consolidated into MDL 3050 under Judge Madeline Cox Arleo. It is still in the initial stages and has not progressed to trial yet.
Chantix Lawsuits Update 2024
As of December 2, 2024, only 17 lawsuits are active and pending in MDL 3050 under the U.S. District Judge, Katherine Polk Failla in the District court of Southern District of New York.
Allegations against Pfizer
On August 31, 2022, the County of Monmouth filed a motion to transfer all Chantix nitrosamine lawsuits to MDL, alleged that Health Canada had alerted Pfizer of nitrosamine contamination in October 2020 itself. However, Pfizer did not take adequate action until June 2021, when it announced a recall of only a few slots of Chantix. Only in September 2021, it called for a nation-wide product recall.
Despite knowing that Chantix contained high levels of N-nitroso-varenicline from the early FDA report, Pfizer kept quiet for long, which harmed many lives.
The Chantix lawsuits accused Pfizer on the following grounds.
- Pfizer knew of the carcinogenic nature of Chantix
- Sold the dangerous drug with high nitrosamine levels
- Marketed Chantix as the most effective anti-smoking drug
- Failed to do proper study on its adverse side effects
- Failed to issue proper warning to the physicians and consumers
Still many lawyers are accepting Chantix lawsuits. Affected individuals can reach out to experienced Chantix cancer lawsuit attorneys to know the prospects of your claim.
Damages Claimed in Chantix Lawsuits
- Medical expenses including the cost of medications, clinical tests, imaging, surgeries, chemotherapy, hospital stays, mobility aids, and home aides
- Income-related losses like lost wages, loss of earning capacity, and missed promotions
- Emotional distress including pain and suffering, loss of quality of life, etc.
- Wrongful death losses like burial expenses, loss of consortium, loss of support and parental guidance
Significance of Medical Record Review in Chantix Lawsuits
In every personal injury claim, medical records play a crucial role in substantiating the injuries. The details of the period of smoking addiction, duration of smoking cessation drug intake, and the adverse side effects experienced are documented in the medical records.
Digging through these voluminous medical records would be a tough task for the Chantix cancer attorneys. Expert medical record review partners can shoulder with Chantix attorneys in relieving their burden and unearth the vital evidence to bolster the Chantix lawsuits.
Rely on LezDo TechMed to identify the strengths and weaknesses of Chantix cancer lawsuits and steer the claims towards assured success.
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To wind up,
While accepting the fact that Chantix has helped many smokers quit smoking addiction and lead a smoke-free life, we cannot overlook the adverse side effects and other complications it has caused. Let’s hope Chantix lawsuits would serve as a warning call to those who are in search of smoking cessation aids and a stark reminder to the pharmaceutical industry that the pursuit of profit should never come at the expense of patient’s health.
Be cautious and be safe!
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