Earlier this month, Pfizer voluntarily recalled the smoking cessation drug Chantix for high levels of nitrosamine, a carcinogenic compound. The notice posted to the Food and Drug Administration (FDA) website included all lots of 0.5 mg and 1 mg varenicline tablets. It also noted that long-term ingestion can lead to a “potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.”
Smoking Cessation Drug Recall
Pfizer first recalled some lots of Chantix in July and added additional lots in August. Recalled drugs include those distributed in the United States, Virgin Islands, and Puerto Rico from May 2019 to September 2021.
The FDA recognized that the current recall may cause a drug shortage. To lessen this impact to patients, it will allow certain manufacturers to distribute “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.”
In a follow-up notice, the FDA encouraged patients to continue using their current medication until their doctor or pharmacist provides a replacement treatment. Ultimately, the heath benefits of stopping smoking outweigh the cancer risk from nitrosamine in varenicline.
For more information about the recall 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.