Drug Safety Alerts

Chantix® Expanded Consumer-Level Recall

9/16/2021

On September 16, 2021, the United States Food and Drug Administration (FDA) published a notice regarding an expanded consumer-level recall of Chantix® 0.5 mg tablets, Chantix® 1 mg tablets, Chantix® Starting Month kit of 0.5 mg/1 mg tablets, and Chantix® Continuing Month kit of 1 mg tablets manufactured by Pfizer. This recall was issued due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

Please note: This recall is an expansion of the previous recalls initiated on July 19 and August 16, 2021. The expanded recall affects all lot numbers.

A complete list of the affected products and lot numbers can be found here.

According to Pfizer, 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. According to Pfizer, people who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. 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 doctor about alternative treatment options, if appropriate. Pfizer has advised that as of the date of recall, it has not received any reports of adverse events that have been related to this recall.

The FDA recommends that patients taking recalled Chantix® continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in Chantix®.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Chantix® 0.5 mg tablets, Chantix® 1 mg tablets, Chantix® Starting Month kit of 0.5 mg/1 mg tablets, and Chantix® Continuing Month kit of 1 mg tablets to contact their prescriber.

For more information, please call Pfizer Medical Information at 1-800-438-1985, Monday through Friday, 9:00 am to 5:00 pm (ET) or visitwww.pfizermedinfo.com. You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.