Pfizer recalls 4 lots of stop-smoking drug chantix over cancer threat – Health Dept.

Washington, Aug 17 (Agency) The US pharmaceutical giant Pfizer is recalling four lots of Chantix, a drug that helps cigarette smokers quit the habit, due to the presence of high levels of the carcinogen nitrosamine (N-nitroso-varenicline), the Food and Drug Administration (FDA) said on Tuesday. “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 FDA said in a press release.

“The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline [Chantix].” Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines, the release said. Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time, the agency added. To date, Pfizer has not received any reports of adverse events that have been related to this recall, according to the release.