Pfizer issues voluntary recall for FDA-approved CHANTIX citing cancer risk

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.

Pfizer originally announced a recall of twelve lots of CHANTIX back in July of this year. The move last Thursday expands the FDA-approved drug to all lots prescribed to the public. The FDA approved CHANTIX on May 10, 2006. According to fiercepharma.com, CHANTIX generated $919 million for Pfizer last year.

What is CHANTIX?

According to Pfizer, Chantix is a treatment to help patients quit smoking and is intended for short term use. Smoking is also associated with many cancers, cardiovascular disease and lung disease.

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.

In July, the FDA allowed Apotex to import generics from Canada. Last month, the agency approved a U.S. generic from Endo’s Par Pharmaceutical.

What lots have been recalled?

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets can be found here.

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 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.

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Content Source: Food and Drug Administration Press Release