Pfizer, Inc. makes Chantix, an anti-smoking drug that contains an ingredient known as varenicline. However, the complaint for this class action alleges that the drug also contains “dangerously high levels of N-nitroso-varenicline, a carcinogenic impurity.” Although the drug has been recalled, the complaint alleges, Pfizer should have known about the impurity earlier, because of earlier warnings about nitrosamine contamination.
The class for this action is all persons in the US who bought Chantix. A Florida Subclass has also been defined for those who bought Chantix in Florida.
According to the complaint, the N-nitroso-varenicline, a nitrosamine, was introduced during the manufacturing process. The Food and Drug Administration (FDA) calls nitrosamines “potent genotoxic agents in several animal species” of which “some are classified as probably or possible human carcinogens by the International Agency for Research on Cancer (IARC).”
Pfizer recalled nine lots of Chantix in July 2021 because they contained “nitrosamine impurity, called N-nitroso-varenicline, above the FDA’s acceptable intake limit.”
Shortly after that, the FDA allowed the temporary distribution of varenicline tablets above their regular acceptable level but below a certain interim level, to ensure that no shortage of varenicline ensued and that patients could continue to access the drug. However, the complaint alleges that the recalled batches contained levels of N-nitroso-varenicline even above the interim permitted level.
On September 16, 2021, the complaint alleges, “Pfizer expanded the recall once again to ‘all lost of Chantix 0.5 and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit.’”
But the complaint alleges that Pfizer should have known about the contaminant: “Specifically, the presence of nitrosamines in prescription medications has been the subject of FDA scrutiny for over three years, as well as international regulators such as the European Medicines Agency (‘EMA’).” EU regulators had found nitrosamines in medicines in 2018, the complaint says, and the FDA began announcing nitrosamine-related recalls that same year.
“Since that time,” the complaint claims, “both the FDA and the EMA have implemented control strategies to ensure that medications entering the market and being sold to consumers are not contaminated with nitrosamines.” The FDA published industry guidance in 2020.
Also, in 2020, Health Canada sent a letter to Apotex, Inc., the Chantix distributor in Canada, warning of a risk of the formation of new nitrosamine impurities in varenicline drug products, the complaint alleges: “Thus, [Pfizer] knew or should have known of the issue of nitrosamine contamination months before it ultimately announced the recalls of the Product.”
“Had [Pfizer] engaged in proper testing of the Product and followed prevailing current Good Manufacturing Processes (‘cGMP’) and industry guidance,” the complaint contends, “it would have known that the Product contain unacceptable amounts of N-nitroso-varenicline.”
Article Type: LawsuitTopic: Consumer
Most Recent Case Event
Chantix Anti-Smoking Drug Contaminated with Nitrosamine Complaint
November 12, 2021
Pfizer, Inc. makes Chantix, an anti-smoking drug that contains an ingredient known as varenicline. However, the complaint for this class action alleges that the drug also contains “dangerously high levels of N-nitroso-varenicline, a carcinogenic impurity.” Although the drug has been recalled, the complaint alleges, Pfizer should have known about the impurity earlier, because of earlier warnings about nitrosamine contamination.
Chantix Anti-Smoking Drug Contaminated with Nitrosamine ComplaintCase Event History
Chantix Anti-Smoking Drug Contaminated with Nitrosamine Complaint
November 12, 2021
Pfizer, Inc. makes Chantix, an anti-smoking drug that contains an ingredient known as varenicline. However, the complaint for this class action alleges that the drug also contains “dangerously high levels of N-nitroso-varenicline, a carcinogenic impurity.” Although the drug has been recalled, the complaint alleges, Pfizer should have known about the impurity earlier, because of earlier warnings about nitrosamine contamination.
Chantix Anti-Smoking Drug Contaminated with Nitrosamine Complaint