According to a release by the Food and Drug Administration, Pfizer has recalled all lots of its smoking cessation drug Chantix because of the presence of the carcinogen N-nitroso-varenicline at levels above FDA-approved limits. The FDA said that long-term ingestion of N-nitroso-varenicline may increase the risk of cancer, but there is no immediate risk to taking the drug. Chantix is intended for short-term use.
The agency added that the health benefits of stopping smoking outweigh the risk of cancer from taking Chantix, and patients currently on the drug should consult with their provider about alternate treatment options.
The FDA said distributors with supplies of Chantix should stop distributing the drug and quarantine it.
Pfizer halted global distribution of Chantix in June after finding the elevated N-nitroso-varenicline levels and recalled nine lots of the drug. In July, the FDA said it would allow drugmakers to sell generic versions of the drug even if they contain low levels of nitrosamines, as the health benefits of quitting smoking outweigh the risk of taking the drug. In August, Pfizer recalled four more lots of the drug.
The FDA has tapped drugmakers Apotex and Par Pharmaceuticals to help address the shortage of Chantix. Cigarette smoking remains the leading cause of preventable disease, disability, and death in the United States, accounting for more than 480,000 deaths every year, or about 1 in 5 deaths according to the CDC.
In 2019, nearly 14 of every 100 U.S. adults aged 18 years or older (14.0%) currently smoked cigarettes. This means an estimated 34.1 million adults in the United States currently smoke cigarettes. More than 16 million Americans live with a smoking-related disease. Current smoking has declined from 20.9% (nearly 21 of every 100 adults) in 2005 to 14.0% (14 of every 100 adults) in 2019, and the proportion of smokers who have quit has also increased.