Pfizer announced that it will pause the distribution of its anti-smoking drug Chantix due to concerns that it contains cancer-causing agents. Last Thursday, the drug company said it found elevated levels of nitrosamines, a known carcinogen, in Chantix pills. Varenicline is the generic name for Chantix.
NDMA in Anti-Smoking Drugs And Other Medicines
As a result, the drugmaker is now recalling a number of lots of Chantix. Previously, the Food and Drug Administration reached out to companies that sold drugs that carried N-nitrosodimethylamine (NDMA) that exceeded acceptable levels.
Last year, the FDA found high concentrations of NDMA in blood pressure medication and some popular versions of the diabetes drug metformin. In addition, NDMA contamination also led to the recall of the popular heartburn drug Zantac in 2019.
As a result of the metformin and valsartan recalls in the previous years, global drug regulators continue to ask companies to monitor for impurities that can occur in certain medicines. Pfizer’s internal testing turned up unacceptable levels in some Chantix batches. As a result, the company is suspending worldwide distribution until it gets a more detailed assessment of the situation.
Pfizer Recalls But Says Benefits Outweigh Risks
The FDA approved Chantix in May 2006 as a prescription medication. Together with proper support, Chantix can help adults aged 18 and over to quit smoking, Treatment usually lasts between 12 and 24 weeks. Global revenues from the anti-smoking drug fell by 17% in 2020 as COVID-19 restrictions slowed down demand. Later that year, Pfizer lost patent protection in the United States.
The multinational drug company said their recall is out of “abundance of caution” and “pending further testing”. Company spokesperson Steven Danehy emailed that “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.”
Dangers of Nitrosamine Exposure
Nitrosamines commonly occur in daily life, as many foods carry the compound. However, the number of nitrosamines found in medicines can potentially expose humans to unsafe levels.
“We have worked hand-in-hand with regulatory authorities around the world who are taking varying approaches and have varying timelines. All information has been communicated publicly per guidance from regulatory authorities,” Danehy added.
Already, the recall is causing the anti-smoking drug stocks to disappear from shelves. Pfizer’s Korea unit informed distributors of the drug’s unavailability. Meanwhile, Canada posted a notice about the recall.
Watch the Ted Bradley video presenting the side effects of Chantix:
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