The U.S. Food and Drug Administration (FDA) recently announced an expanded recall of Chantix (varenicline) to include all lots of 0.5mg and 1mg tablets. Pfizer is pulling the smoking cessation drug because of concerning levels of N-nitroso-varenicline, which may be associated with an increased risk of cancer in humans.
Timeline of Expanded Recall for Chantix
On July 2, 2021, the FDA first notified patients and providers about the recall of nine lots of Chantix. At this point, Pfizer recalled a limited number of products due to the presence of the nitrosamine.
Nitrosamines are commonly found in water and foods, meaning that everyone is exposed to them in some way. However, the risk of cancer may increase if people are exposed at high levels over a long period of time. Still, the FDA noted that there was no immediate risk to patients taking the mediation. In fact, the benefits of quitting smoking outweighed the theoretical and potential risk of cancer.
Pfizer continued selling the believed-to-be safe lots of the smoking cessation drug. Then, on July 19, 2021, the company expanded the recall to 12 lots, based on the same concern as the initial recall.
Approximately a month later, on August 18, 2021, the manufacturers added four more lots to the list. Then, per the most recent update, Pfizer issued a statement about the final expanded recall, which is inclusive of all lots of of the 0.5mg and 1mg tablets. As they work to reduce or eliminate the impurity in future lots, the FDA said that it would not object to “certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above the acceptable limit intake of 37ng per day but below the interim acceptable intake limit of 185ng per day.”
Connection to Other Recent Recalls
Similarly, the FDA requested the removal of all Zantac from shelves in April 2020. There was concern that the heartburn drug contained unsafe levels of N-nitrosodimethylamine (NDMA), another impurity related to cancer. As a result, multiple lawsuits have been filed against the manufacturers.
Several other drugs, including high blood pressure medications like valsartan and losartan, have been impacted by nitrosamine impurities in recent years. This issue may be caused by changes in manufacturing as well as improved testing methods that allow the components to be identified at very low levels.
For more information about the halted distribution of Chantix, contact us today.
Additional Reading:
Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.