Pfizer makes the drug Chantix to help people stop smoking. The complaint refers to Chantix as a VCD, or varenicline-containing drug. But the complaint for this class action alleges that the company has been putting out adulterated or misbranded Chantix that has been contaminated with “a probable human carcinogen known as n-nitroso-varenicline.” The complaint alleges that Pfizer had been warned about this possibility and “was on notice of other potential nitrosamines as well, such as n-nitrosdimethylamine (‘NDMA’) and n-nitrosodiethlamine (‘NDEA’).”
The National Class for this action is all individuals and entities in the US and its territories and possessions who paid any amount for a VCD, for personal or household use, that was manufactured, distributed, or sold by Pfizer. A Florida Subclass has also been proposed for individuals and entities in Florida.
Chantix works by interfering with nicotine receptors in the brain, reducing the pleasure a person gets from smoking and thereby also reducing their need to smoke.
Chantix has quickly grown in popularity, and its price has grown as well. The Food and Drug Administration (FDA) approved it in 2006, and the complaint puts its price at its launch at $113.98 for a thirty-day supply, rising rapidly to $485 in 2019.
It has been very profitable for the company, the complaint alleges, bringing in $919 in 2020. The complaint claims, “Pfizer extended patent protection on Chantix to ensure exclusivity through at least August 2022, thus ensuring Pfizer’s Chantix is the exclusive varenicline product without generic competition currently.”
Drugs must be made according to current Good Manufacturing Practices (cGMP) to make sure they meet standards for safety, quality, purity, identity, and strength. If another entity manufactures a company’s drug, the company must have a quality control unit to test the resulting drug.
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.”
In October 2020, Health Canada issued a warning about the risk of nitrosamine impurities in varenicline drugs. The complaint alleges, “NDMA can be unintentionally produced in and released from industrial sources through chemical reactions involving other chemicals…” However, the complaint alleges that Pfizer and its quality control unit did not fulfill their responsibilities to detect the contamination in its drugs.
The complaint alleges that FDA testing at some point showed NDMA contamination in the VCDs. Pfizer recalled some Chantix on July 2 and 19, 2021, then recalled all Chantix on September 16, 2021. The complaint alleges, “The FDA has yet to release full testing results for other nitrosamine impurities.”
The complaint alleges, “Upon information and belief, N-nitroso-varenicline contamination of [Pfizer’s] dates back many years…”
Article Type: LawsuitTopic: medical
Most Recent Case Event
Pfizer Chantix Contaminated with NDMA Complaint
October 12, 2021
Pfizer makes the drug Chantix to help people stop smoking. The complaint refers to Chantix as a VCD, or varenicline-containing drug. But the complaint for this class action alleges that the company has been putting out adulterated or misbranded Chantix that has been contaminated with “a probable human carcinogen known as n-nitroso-varenicline.” The complaint alleges that Pfizer had been warned about this possibility and “was on notice of other potential nitrosamines as well, such as n-nitrosdimethylamine (‘NDMA’) and n-nitrosodiethlamine (‘NDEA’).”
Pfizer Chantix Contaminated with NDMA ComplaintCase Event History
Pfizer Chantix Contaminated with NDMA Complaint
October 12, 2021
Pfizer makes the drug Chantix to help people stop smoking. The complaint refers to Chantix as a VCD, or varenicline-containing drug. But the complaint for this class action alleges that the company has been putting out adulterated or misbranded Chantix that has been contaminated with “a probable human carcinogen known as n-nitroso-varenicline.” The complaint alleges that Pfizer had been warned about this possibility and “was on notice of other potential nitrosamines as well, such as n-nitrosdimethylamine (‘NDMA’) and n-nitrosodiethlamine (‘NDEA’).”
Pfizer Chantix Contaminated with NDMA Complaint