Last month, Pfizer announced a pause in the distribution of smoking-cessation drug Chantix (varenicline) after identifying levels of nitrosamines, a potential carcinogen. The levels in drugs aren’t supposed to exceed an excess cancer risk of 1 in 100,000. The manufacturer is recalling multiple lots of the drug for the same reason.
In 2020, the Food and Drug Administration (FDA) discovered high amounts of NDMA (N-nitrosadimethylamine) in numerous drugs, including the diabetes drug metformin. In 2019, heartburn medication Zantac was also recalled due to NDMA contamination.
The History of Chantix
Chantix, which is used for 12 to 24 weeks, was initially approved by the FDA in May 2006 to help adults 18 and over quit smoking. Pfizer indicated that they were stopping distribution “out of an abundance of caution” and would continue investigations. They haven’t revealed which nitrosamines were discovered in the pills or how they got there.
Prior to the sales halt, the drug was already facing issues. Sales recently dropped 17 percent — from $1.1 billion in 2019 to $919 million in 2020 — due to the COVID-19 pandemic and the loss of patent protection in the United States in November.
As company spokesperson Steven Danehy told Reuters, Pfizer believe “the benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime.” It’s important to note that the potential carcinogen is also found in water and grilled meat.
For more information about the halted distribution of Chantix, contact us today.
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.