Chantix, a drug made by Pfizer, Inc., is designed to help people stop smoking. Its active ingredient is varenicline. But the complaint for this class action alleges that Chantix contains dangerously high levels of N-nitroso-varenicline, an impurity which is a carcinogen.
The class for this action is all persons in the US who bought Chantix containing N-nitroso-varenicline. A New Jersey Subclass has also been defined for those who bought the Chantix containing N-nitroso-varenicline in New Jersey.
Chantix contains varenicline, substance that attaches to nicotine receptors in the brain, so that nicotine cannot attach there. Like nicotine, it releases dopamine, although not as much. These operations are designed to help smokers resist the urge to smoke.
“However,” the complaint alleges, Pfizer’s “manufacturing process has caused certain lots of Chantix to contain dangerously high levels of N-nitroso-varenicline, a carcinogenic impurity which was not designed to be in the medication.” N-nitroso-varenicline is classified as a nitrosamine, a chemical compound that is considered to be a “probable human carcinogen[],” the complaint says, “on the basis of animal studies.”
The complaint quotes the Food & Drug Administration (FDA) as saying that some nitrosamines “are classified as probably or possible human carcinogens … based on laboratory tests such as rodent carcinogenicity studies.”
The FDA recalled nine lots of Chantix on July 2, 2021 because of the presence of “a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit.”
Later, however, the FDA published another announcement designed to ensure that patients already using the drug would not be affected by shortages. Although it normally set an acceptable intake limit of 37 ng of N-nitroso-varenicline per day, the FDA said, it would temporarily permit the sale of drugs with more than that level, as long as it was below an intake limit of 185 ng per day, “until the impurity can be eliminated or reduced to acceptable levels.”
On July 12, Pfizer expanded its recall to twelve lots of Chantix. It also advised consumers to consult with their health care providers and stop using any of the recalled lots.
The complaint alleges that the presence of nitrosamines in prescription drugs has been scrutinized by the FDA as well as the European Medicines Agency (EMA) for the past three years, since they were discovered in certain blood pressure medicines. In September 2020, the FDA published guidance on N-Nitrosamine impurities in drugs.
The complaint alleges that Pfizer therefore had reason to know be aware of the presence of N-nitroso-varenicline in its drugs but failed to warn consumers. The complaint calls the drug as purchased by consumers “economically worthless” and “generally unfit for human consumption.”
The complaint alleges breaches of warranties and fraud, among other things.
Article Type: LawsuitTopic: Consumer
Most Recent Case Event
Pfizer Chantix Stop-Smoking Drug Contains Impurity Complaint
August 12, 2021
Chantix, a drug made by Pfizer, Inc., is designed to help people stop smoking. Its active ingredient is varenicline. But the complaint for this class action alleges that Chantix contains dangerously high levels of N-nitroso-varenicline, an impurity which is a carcinogen.
Pfizer Chantix Stop-Smoking Drug Contains Impurity ComplaintCase Event History
Pfizer Chantix Stop-Smoking Drug Contains Impurity Complaint
August 12, 2021
Chantix, a drug made by Pfizer, Inc., is designed to help people stop smoking. Its active ingredient is varenicline. But the complaint for this class action alleges that Chantix contains dangerously high levels of N-nitroso-varenicline, an impurity which is a carcinogen.
Pfizer Chantix Stop-Smoking Drug Contains Impurity Complaint