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Pharmaceutical giant Pfizer is recalling 12 lots of its popular anti-smoking drug Chantix after the company discovered the products contain high levels of a chemical that may cause cancer.
The voluntary move expands on a recall that covered nine lots of Chantix, which goes by the generic name varenicline, and was issued to warehouses earlier this month.
Pfizer said it found N-nitroso-varenicline, which is a type of organic compound called a nitrosamine, in the product at levels higher than the company’s so-called acceptable intake limit.
Nitrosamines can develop naturally in a broad range of items, including meats, cheeses and cosmetics. The FDA has warned that long-term exposure to high levels of nitrosamines can increase the risk of cancer.
The company insisted that the presence of the chemical “may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.”
“The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline,” Pfizer said in a statement.
Pfizer noted that nitrosamines — like N-nitroso-varenicline — are “common in water and foods, including cured and grilled meats, dairy products and vegetables.”
“Everyone is exposed to some level of nitrosamines,” the company said.
Pfizer stopped short of telling people who are currently taking Chantix to stop using the drug. Instead, the company said, they should consult with their doctor.
“To date, Pfizer has not received any reports of adverse events that have been related to this recall,” the company.
The recall covers two 0.5 mg tablet lots, two 1.0 mg lots, and eight lots of a Chantix kit that includes both 0.5 mg and 1.0 mg doses, the company said. Pfizer said it shipped the products throughout the US and Puerto Rico between June 2019 and June 2021.