Pfizer recalls anti-smoking drug due to high levels of ingredients linked to increased risk of cancer

Pfizer has recalled its anti-smoking drug Chantix due to high levels of an ingredient linked to an increased risk of cancer.

In a notice posted on the Food and Drug Administration (FDA) website Thursday, Pfizer said it was recalling Chantix 0.5 mg and 1 mg tablets from the consumer due to the presence of N-nitroso-varenicline.

Long-term ingestion of N-nitroso-varenicline may be associated with a “theoretical increased risk of cancer in humans,” the advisory says. However, there is no immediate risk to patients taking the drug.

The company said it was undertaking the recall as a precaution, adding that the benefits of stopping smoking “outweigh the theoretical potential cancer risk from the impurity nitrosamine.”

The company is recalling all batches of the drug that were distributed to wholesalers and distributors in the United States, the United States Virgin Islands and Puerto Rico from May 2019 through September.

In a friday update, the FDA said patients should continue to take their medications until their pharmacists replace them or their doctors prescribe a different treatment.

N-nitroso-varenicline is a nitrosamine, which is common in water and food.

Everyone is exposed to nitrosamines at some level. However, they can increase the risk of cancer if people are exposed above a certain limit.

Pfizer previously recalled 12 lots of Chantix in July due to the presence of N-nitroso-varenicline. Last month he recalled four more lots due to the impurity.