Chantix (Vareniclin)

2021: Withdrawal of the drug due to cancer risk

At the end of September 2021, Pfizer voluntarily withdraws all batches of its popular anti-smoking drug Chantix due to its high nitrosamine content, which can increase the risk of cancer. Wholesalers and distributors with pill stocks should immediately stop using and distributing them and quarantine the product.

According to a notice published on the Food and Drug Administration (FDA) website, all batches of varenicline tablets 0.5 mg and 1 mg are recalled. The recall notice states that long-term administration of the drug may lead to a potential increased risk of cancer in a person, however, there is no immediate risk for patients taking this medicine.

Pfizer recalls anti-smoking drug Chantix that causes cancer

The FDA reported on September 17, 2021 that patients should continue to take the current medicine until a pharmacist provides a replacement or a doctor prescribes another treatment.

Pfizer recalled some batches of the anti-smoking drug in July 2021 and expanded the recall to additional batches in August 2021. Recalled drugs were distributed nationwide among wholesalers and distributors in the United States, the Virgin Islands and Puerto Rico from May 2019 to September 2021.

The FDA acknowledged that the ongoing recall could cause drug shortages and said that to reduce patient exposure, the federal agency would not object to some manufacturers distributing varenicline tablets containing N-nitrosovarenicline in amounts above the FDA-permissible consumption limit of 37 ng per day. However, manufacturers are required to comply with the maximum consumption level of 185 ng per day until the impurity is eliminated or reduced to an acceptable level. The health benefits of smoking cessation outweigh the risk of cancer due to nitrosamine admixture in varenicline.

Undesirable reactions or quality problems encountered with this product can be reported to the FDA MedWatch Adverse Event Reporting program via the Internet, mail, or fax.^[1]

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