July 20, 2021
Pfizer has recalled multiple lots of Chantix® (varenicline) and paused global distribution after testing identified N-nitroso-varenicline, a nitrosamine impurity.
According to the U.S. FDA:
“N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. An increased cancer risk would be associated with long-term use, and the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.”
Chantix is FDA approved to aid in smoking cessation. Stopping smoking can improve a person’s health, enhance quality of life, extend life expectancy, and reduce the risk of serious illnesses such as cardiovascular disease, chronic obstructive pulmonary disease (COPD), and cancer. The FDA advises patients using Chantix to continue taking the medication until given a replacement or different treatment option by a doctor or pharmacist. Patients who are taking the medication and have questions about their health should contact their healthcare provider.
For healthcare providers, the FDA recommends considering other available treatment options for patients and quarantining any varenicline samples from Pfizer. Healthcare providers should contact Pfizer directly with any questions regarding product return or disposal.
The FDA will temporarily exercise regulatory flexibility to allow U.S. distribution of Apo-Varenicline, a varenicline product manufactured by Apotex and distributed in Canada, to help maintain adequate varenicline supply. To be distributed in the U.S., Apo-Varenicline cannot contain N-nitroso-varenicline in excess of the 185ng per day interim acceptable intake limit.
A full copy of the recall announcement can be found on the FDA’s website.
There is minimal member impact through Benecard Central Fill.