Pfizer recalls all lots of Chantix

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Article Summary: Pfizer has voluntarily recalled all lots of Chantix, a smoking cessation drug due to the presence of a carcinogenic substance.

By Maia Anderson, Becker’s Hospital Review, Sep 17, 2021.

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 Sept. 16 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. 

Pfizer said it hasn’t received any adverse events notifications for Chantix related to the recall. 

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.

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