Pfizer is voluntarily recalling all lots of its popular anti-smoking drug Chantix for high levels of nitrosamine, which can increase the risk of cancer. The recall notice says that long-term ingestion can lead to a “potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.” he company said it is undertaking the recall as a precautionary measure, adding that the benefits of stopping smoking “outweigh the theoretical potential cancer risk from the nitrosamine impurity.” N-nitroso-varenicline is a nitrosamine, which are common in water and foods. Everyone is exposed to nitrosamines at some level but the quantity is to be considered. The recalled drugs were distributed nationwide to wholesalers and distributors in the U.S., Virgin Islands and Puerto Rico from May 2019 to September 2021.
The recall is for all lots of 0.5 mg and 1 mg varenicline tablets (Chantix). Chantix is a pill the FDA approved in 2006 as a prescription medication which helps adults aged 18 and over quit smoking and is used for 12 to 24 weeks. FDA said in an update Friday that patients should “continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment.” Pfizer paused distribution of Chantix back in July after finding elevated levels of nitrosamines in the pills.