Citing the presence of a cancer-causing agent, Pfizer has decided to voluntarily recall all lots of Chantix (varenicline) 0.5 mg and 1 mg tablets, a medication that helps users to quit smoking.
The action was taken in response to the detection of the carcinogenic substance nitrosamine, N-nitroso-varenicline, at or above the level determined by the FDA as acceptable, the company said in a statement. While long-term ingestion of nitrosamine can be linked to increased risk of cancer in humans, “the health benefits of stopping smoking outweigh” the cancer risk due to the presence of nitrosamine in varenicline, Pfizer added.
In June, the U.S. pharma giant halted the worldwide distribution of Chantix, noting nitrosamine levels above the “acceptable” daily intake.
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