FDA: Pfizer Expands Recall of Smoking Cessation Drug Chantix

Pfizer has expanded its voluntary recall of smoking cessation drug Chantix, according to an update posted on the FDA website.

Pfizer is voluntarily recalling all lots of Chantix 0.5 mg 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. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.ⁱ

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.ⁱⁱ

Smoking is also associated with many other cancers, as well as with cardiovascular disease and lung disease.ⁱⁱⁱ CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their healthcare provider about alternative treatment options. To date, Pfizer has not received reports of adverse events assessed to be related to this recall.

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets are indicated in Appendix A. Photos of the products can be found in Appendix B. The products were distributed nationwide to Wholesalers and Distributors in the United States, US Virgin Islands and Puerto Rico from May 2019 to September 2021.

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

Wholesalers and Distributors with an existing inventory of Chantix tablets, should stop use and distribution and quarantine the product immediately.