Pfizer has issued a recall of Chantix 0.5 mg and 1 mg Tablets 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.
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.
CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a 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 products were distributed nationwide from May 2019 to Sept. 2021.
Wholesalers and Distributors with an existing inventory of Chantix tablets should stop use and distribution and quarantine the product immediately.
Patients with Chantix Tablets should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.