Voluntary Recall Comes Following Discovery of High Levels of N-Nitroso-Varenicline
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Pfizer has expanded its September 16, 2021 voluntary recall of smoking cessation aid Chantix to include all lots of the 0.5mg and 1mg tablets. The recall comes following the discovery of high N-nitroso-varenicline levels above the acceptable limit set by the Food and Drug Administration (FDA).
Ingestion of N-nitroso-varenicline at high levels may be associated with a potential increased risk of cancer. In a September 16, 2021 company announcement issued by Pfizer, they stated:
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 health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.i
Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.
In a September 17, 2021 update issued by the FDA, the agency notified consumers that while the voluntary recall is still in place, the FDA will allow certain manufacturers to continue to distribute the drug under certain restrictions temporarily in order to avoid a drug shortage:
To lessen the impact to patients from a drug shortage due to this ongoing recall, FDA will not object to certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.
The agency has temporarily exercised regulatory flexibility and discretion with respect to Apotex's distribution of Health Canada-approved Apo-Varenicline tablets in the U.S. containing N-nitroso-varenicline up to FDA’s interim acceptable intake limit in order to help maintain adequate varenicline supply in the U.S. for the near term.
FDA reminds patients taking recalled varenicline to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.
Pfizer claims to have notified their direct consignees by letter in order to arrange for the return of the recalled product. In the September 16, 2021 communication from the company, the following instructions were given for those who believe they may possess any of the recalled products:
As communicated by FDA, there is no immediate risk to patients taking Chantix. Patients who are taking this product should consult with their health care provider to determine if alternate treatments are available. Patients with Chantix Tablets should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.
As always, we will continue to monitor voluntary and FDA mandated drug recalls and will provide you with any new or relevant information. Please feel free to share any relevant information with us, as well.
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