Pfizer recalls all lots of the anti-smoking drug Chantix due to its carcinogenic presence


Pfizer is voluntarily recalling all lots of its anti-smoking drug Chantix due to the high levels of carcinogens called nitrosamines in the pills.

The recall affects all batches of 0.5 mg and 1 mg tablets of varenicline, the Food and Drug Administration said Thursday. Long-term ingestion of the drug may lead to a “potentially increased risk of cancer in humans, but there is no immediate risk to patients taking this drug.”

Because of this, the FDA said on Friday that patients taking the recalled drug “should continue to take their current drug until their pharmacist provides a replacement or their doctor prescribes a different treatment.”

“The health benefits of quitting smoking outweigh the cancer risk from the nitrosamine impurity in varenicline,” the FDA added.

Pfizer initially suspended distribution of the drug in June and has already recalled a number of batches of the drug so far. At the time, the company said the break in distribution was made out of caution, pending further testing. Pfizer then extended the recall to additional batches of the anti-smoking drug in August.

Chantix was approved by the FDA in May 2006 as a prescription drug to help adults aged 18 and over quit smoking and is typically used for 12 to 24 weeks.

Reuters contributed.

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