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

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

 

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.