Class Action Lawsuit Filed Over Presence of Toxic Chemicals in Chantix

Lawsuits claim the presence of nitrosamines make Chantix an adulterated drug never approved by the FDA.

In response to problems with toxic chemicals in Chantix, Pfizer faces another class action lawsuit over the recalled stop-smoking drug, which was distributed with nitrosamine impurities that may increase the risk of cancer.

The complaint (PDF) was filed Daniel Spence and Carita Thompson in the U.S. District Court for the Northern District of Illinois on November 24, joining a growing number of claims filed in the wake of several Chantix recalls issued in recent months, seeking class action status to pursue damages for consumers who paid for the expensive smoking cessation drug, which was adulterated and unfit for its intended purpose.

Chantix (varenicline) was introduced by Pfizer in 2006, as a prescription medication designed to help people quit smoking. However, the manufacturer halted Chantix distribution in June, when it was discovered pills may contain dangerous levels of nitrosamines, which are believed to be a byproduct of the drug manufacturing process and may expose users to a risk of cancer.

The lawsuit points out that, since its launch, the cost of Chantix climbed dramatically. What started out as $113.98 for a 30-day supply, eventually climbed to nearly $500 for the same amount by 2018. That year, Pfizer raked in just under $1 billion in Chantix sales. However, the lawsuit notes that because of the presence of nitrosamines, consumers were not buying Chantix as advertised, but instead were buying a varenicline-containing drug (VCD) which was never approved by the FDA.

Over the last few years, several drugs, such as Zantac, valsartan and metformin, have faced similar recalls over toxic chemicals that never should have been in the pills, primarily involving the presence of a nitrosamine known as N-Nitrosodimethylamine (NDMA). As a result, thousands of Zantac lawsuits, valsartan lawsuits and metformin lawsuits are now being pursued against those drug makers.

Pfizer first disclosed the Chantix problems in June, after halting distribution for the drug and recalling one lot in Canada. Weeks later, the Chantix recall was expanded to include 12 batches of the medication sold in the United States in July, and the drug maker announced that it was recalling another four lots of Chantix in August 2021.

In September, Pfizer issued a press release announcing a complete Chantix recall for all lots of both its 0.5 mg and 1 mg tablets, all due to the same problem first discovered in June 2021, with high levels of the cancer-causing chemicals in certain pills, at levels higher than deemed acceptable by the FDA.

“Upon information and belief, N-nitroso-varenicline contamination of Defendant’s VCDs dates back many years, at which point Defendant had actual and/or constructive notice of the contamination,” the lawsuit states. “Ironically, the Defendant’s wrongful acts resulted in persons who sought to use smoking products less receiving a Chantix pill that contained a carcinogen.”

Pfizer indicates it has received no reports of adverse events linked to the toxic chemicals in Chantix, but exposure to nitrosamine impurities in other pills has been linked to reports of cancer as the chemicals move through the body.

This latest joins several others in seeking nationwide class action status for anyone who paid any amount for Chantix sold by Pfizer.