0.5-mg and 1-mg tablets may contain levels of N-nitroso-varenicline at or above levels approved by the FDA<\/p>\n<\/h3>\n
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FRIDAY, Sept. 17, 2021 (HealthDay News) — Pfizer is expanding the recall of its antismoking drug Chantix (varenicline), the company announced Friday.<\/p>\n
The nationwide recall of all Chantix 0.5-mg and 1-mg tablets was prompted because they may contain levels of a nitrosamine, N-nitroso-varenicline, that are at or above levels approved by the U.S. Food and Drug Administration.<\/p>\n
Long-term ingestion of N-nitroso-varenicline may be linked to a “theoretical potential increased cancer risk in humans,” the company said, adding that no immediate risk to patients taking Chantix exists.<\/p>\n
“The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline,” Pfizer said in its statement.<\/p>\n
So far, Pfizer has received no reports of adverse events tied to this recall, the company stated.<\/p>\n