Pfizer, Inc. makes the varenicline-containing drug (VCD) Chantix, which is used to help smokers stop smoking. The complaint for this class action alleges that Chantix has recently been adulterated or misbranded because it has been contaminated with a probable carcinogen called N-nitroso-varenicline.
The National Class for this action is all entities in the US or its territories and possessions who paid any amount of money for a varenicline-containing drug, for personal or household use, that was made, distributed, or sold by Pfizer. A Massachusetts Subclass has also been defined for those in the above class in Massachusetts.
Chantix does not contain nicotine; the complaint claims it works by interfering with the brain’s nicotine receptors, which reduces the cravings for a smoke or the pleasure a person derives from smoking. The Food and Drug Administration (FDA) originally approved Chantix in May 2006, but the Pfizer has been able to extend its patent rights to August 2022.
Unfortunately, the complaint alleges that recent versions of the drug were contaminate with N-nitroso-varenicline, a probable human carcinogen. The complaint also alleges that Pfizer “was on notice of other potential contamination from” other nitrosamines, including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
“According to FDA testing,” the complaint alleges, Pfizer’s “VCDs contained nitrosamine levels many times higher than the FDA’s updated interim limits for nitrosamine impurities.”
The complaint claims that this is because Pfizer did not follow current Good Manufacturing Practices (cGMPs) when making and distributing Chantix. “When a drug is manufactured in a non-cGMP compliant manner,” the complaint alleges, “that means the manufacturer cannot assure that the drugs meet the appropriate quality, purity, identity or strength. Accordingly, such drugs are adulterated or misbranded or both.”
Pfizer began recalling the drugs in July 2021 and recalled all Chantix in September of that year, but the complaint alleges, “The FDA has yet to release full testing results for other nitrosamine impurities.” The complaint suggests that the contamination of the drug goes back many years, “at which point [Pfizer] had actual or, at a minimum, constructive notice of the contamination.”
In support of this, the complaint cites an October 2020 letter sent by Health Canada (the Canadian equivalent of the FDA) to a company called Apotex, Inc., a company that was distributing a varenicline product in Canada. The letter warned the company of the risk of the presence of nitrosamine contamination in drugs. According to the complaint, Health Canada also sent Pfizer a notice with the same warning about Chantix, which was being sold in Canada.
Also, the complaint alleges, “The pharmaceutical industry has been aware of the potential for the formation of nitrosamines in pharmaceutical drugs at least as far back as 2005, or earlier.” However, the complaint claims that Pfizer took no action to investigate these issues with respect to Chantix.
Article Type: LawsuitTopic: Consumer
Most Recent Case Event
Chantix Stop-Smoking Drug Adulterated with Nitrosamines Complaint
November 7, 2022
Pfizer, Inc. makes the varenicline-containing drug (VCD) Chantix, which is used to help smokers stop smoking. The complaint for this class action alleges that Chantix has recently been adulterated or misbranded because it has been contaminated with a probable carcinogen called N-nitroso-varenicline.
Chantix Stop-Smoking Drug Adulterated with Nitrosamines ComplaintCase Event History
Chantix Stop-Smoking Drug Adulterated with Nitrosamines Complaint
November 7, 2022
Pfizer, Inc. makes the varenicline-containing drug (VCD) Chantix, which is used to help smokers stop smoking. The complaint for this class action alleges that Chantix has recently been adulterated or misbranded because it has been contaminated with a probable carcinogen called N-nitroso-varenicline.
Chantix Stop-Smoking Drug Adulterated with Nitrosamines Complaint