Excessive Impurities Cause Recall of Pfizer’s Anti-Smoking Drug

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Excessive Impurities Cause Recall of Pfizer’s Anti-Smoking Drug


Pfizer has issued a voluntary recall for 12 lots of its anti-smoking drug Chantix (varenicline) due to the presence of a nitrosamine impurity exceeding the company’s established Acceptable Daily Intake (ADI) level. As a result, the company is pausing distribution of Chantix and is accelerating its internal testing of the drug.

In a statement published yesterday, the U.S. Food and Drug Administration (FDA) announced Pfizer has voluntarily recalled two lots of Chantix 0.5 mg tablets, two lots of Chantix 1 mg tablets, and eight lots of a Chantix kit consisting of 0.5mg/1 mg tablets. These lots appear to have levels of N-nitroso-varenicline above the Pfizer-established ADI.

The FDA stated N-Nitroso-varenicline is found within the nitrosamine class of compounds, and some of these compounds are either possible or probable carcinogens. “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” the FDA said. 

Despite this risk, the agency emphasized the much larger benefit of smoking cessation on decreasing cancer risk: “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

In addition, the FDA notes everyone is exposed to nitrosamines at some level, as these are commonly found in water as well as foods, such as cured and grilled meats, dairy products, and vegetables. “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the agency said.

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Chantix is approved to help smokers quit, but the drug is only intended for short-term treatment. The FDA says people who smoke cigarettes are 15 to 30 times more likely to be diagnosed with lung cancer than those who don’t smoke.

To date, Pfizer has not received any adverse event reports associated with the recall. Still, patients taking Chantix are encouraged to talk with their physicians to see if they have taken an affected lot. The FDA recommended in an update on Friday that patients prescribed the recalled drug to “continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.”

The pharma and medical device industries are no strangers to product recalls. Most recently, Johnson & Johnson recalled all lots of its Neutrogena Beach Defense and Ultra Sheer sunscreens due to elevated levels of benzene in these products. Long-term exposure to benzene may increase the risk of certain cancers, among other health concerns.

In June, Royal Philips issued a voluntary recall notification for Philips Bi-Level Positive Airway Pressure, Continuous Positive Airway Pressure, and mechanical ventilator machines to address potential health risks associated with the devices’ polyester-based polyurethane sound abatement foam component.

Other recent recalls include Aziyo Biologics’ voluntary recall of a single donor lot of FiberCel Fiber Viable Bone Matrix. This bone repair product recall was made after the company learned of incidences of post-surgical infections in people who were treated with the product.


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