FDA Update on Chantix with Nitrosamine Impurity

To ensure patient access to Chantix (varenicline), the FDA will not object to certain manufacturers temporarily distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels. The agency continues to evaluate data and may update the interim acceptable limit in the future.

Apotex distributes varenicline in Canada under the name Apo-Varenicline. FDA’s temporary exercise of regulatory flexibility and discretion with respect to Apotex's distribution of Apo-Varenicline tablets in the U.S. containing N-nitroso-varenicline up to FDA’s interim acceptable intake limit of 185 ng per day will help maintain adequate varenicline supply in the U.S. for the near term. See FDA’s Drug Shortages page for more information.

Agency scientists evaluated the risk of exposure to N-nitroso-varenicline at interim acceptable intake levels up to 185 ng per day and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to N-nitroso-varenicline at the 37 ng per day level.

FDA reminds patients taking recalled varenicline to 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 varenicline.