Pfizer, the maker of Chantix, has issued a voluntary nationwide recall for the drug due to the potential presence of a carcinogen detected during testing.
NEW YORK CITY — Pharmaceutical giant Pfizer is voluntarily recalling all lots of its anti-smoking drug Chantix due to the detection of levels of cancer-causing agents called nitrosamines in the presence of the pills. The recall is for lots of the .5 mg and 1 mg varenicline tablets, reports the Food and Drug Administration.
Long-term ingestion of the drug can lead to “potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.” “The agency has temporarily exercised regulatory flexibility and discretion with respect to Apotex’s distribution of Health Canada-approved Apo-Varenicline tablets in the U.S. containing N-nitroso-varenicline up to FDA’s interim acceptable intake limit in order to help maintain adequate varenicline supply in the U.S. for the near term,” the FDA said.
“The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline,” FDA adds.
“FDA reminds patients taking recalled varenicline to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.” According to the maker of Chantix, the drug mimics a low dose of nicotine, which eases potential symptoms of what is commonly shared with withdrawal.
The drug also blocks nicotine from binding to receptors, essentially rendering nicotinic reception an ineffective means. If a person takes Chantix while smoking, they don’t get the normal boost of nicotine and the sensation of smoking becomes bland.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables,” reports the FDA. “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.”