Pfizer Issues New Nationwide Consumer Recall of Anti-Smoking Drug Chantix Due to Potential Cancer Risk; What You Need to Know About NDMA

The issue is that the amount of the nitrosamine in question, N-nitroso-varenicline, that is present in the medication is above the Pfizer-established Acceptable Daily Intake (ADI) level.

It is a voluntary recall that parent company Pfizer quietly announced last week, managing to fly under the radar until the Food and Drug Administration posted the news on its website Monday.

This comes just two weeks after the pharmaceutical giant issued a recall at the warehouse level for the prescription medication after elevated levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some pills.

The Food and Drug Administration had been urging the company to issue a recall at the consumer level for some time, a suggestion that the drugmaker finally agreed to, according to a release sent out by the government agency.

The FDA approved the drug in May 2006 to help adults age 18 and over quit smoking, which remains the number one risk factor for developing lung cancer. The medication is typically used for 12 to 24 weeks.

Pfizer previously suspended distribution of the drug just six days ago out of an abundance of caution.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline (Chantix) on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

Pfizer will continue to delay the release of varenicline in the U.S. until testing confirms that N-nitroso-varenicline levels are below what the company considers to be acceptable.

RELATED: Heartburn Drug Zantac Must Be Fully Removed From Shelves

The FDA says that individuals should not stop taking Chantix without speaking to a medical professional. At the same time, the agency is recommending that health care professionals look for other options to treat patients. Any Chantix that these healthcare workers have on hand should be quarantined, the FDA says, and not provided to patients. The FDA says it is “actively considering options to help mitigate a shortage of varenicline in the U.S. including working to identify an alternate supplier.”

In June 2020, the FDA asked companies to recall the popular diabetes drug metformin due to an apparent cancer risk. The agency said that a high level of NDMA was found in several batches of the extended-release form of the drug, which is often prescribed to control high blood sugar in patients with type 2 diabetes. NDMA contamination was also responsible for the recall of heartburn drug Zantac sold by Sanofi SA in 2019.

What is NDMA?

NDMA is a chemical that can be unintentionally formed during various manufacturing processes, according to the Centers for Disease Control and Prevention (CDC). People can be exposed to low levels of NDMA in a variety of ways it can be found in foods like cured meats and fish, beer, tobacco smoke and even in some toiletry and cosmetic products. NDMA is labeled as a “probable carcinogen,” meaning it may cause cancer in humans.

Essentially, NDMA is all around us at low levels. When it comes to cancer risk, it’s difficult for medical professionals to say exactly how dangerous the substance is.

“We don't really know long term exactly what the risk is… we do know that there is some potential for cancer and liver issues,” Dr. Tan says.

The FDA considers the chemical generally safe as long as exposure does not exceed a certain limit and people are not exposed for a long period of time.

To avoid potential dangers, the FDA regularly tests and monitors products like medications to ensure that they only contain what the agency considers to be safe levels of contaminants like NDMA. The metformin recall in June 2020 came after the agency determined that the extended-release form of the drug had NDMA levels that were above the FDA’s “acceptable intake limit.”

The acceptable intake limit for NDMA is 96 nanograms per day for medications, according to the FDA.

Contributing: Laura Gesualdi-Gilmore, Alison Maxwell, Chris Spargo

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