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Most people are aware of the health benefits of stopping smoking. However, it can be quite challenging to do so. Chantix is a smoking cessation drug that a doctor prescribes for 3-6 months to help you quit smoking. 

In July 2021, the pharmaceutical company Pfizer issued a voluntary nationwide recall of Chantix (varenicline) tablets as a precautionary measure; this is due to the evidence of higher levels of nitrosamines in Chantix than what’s considered acceptable by the U.S. FDA.

The recalled drugs (Chantix tablets) were distributed nationwide in the US and its territories between May 2019 and September 2021. By the end of the summer of 2021, along with recalling all lots nationwide, Pfizer had completely halted the global distribution of Chantix. 

The presence of nitrosamines has led to the recalls of some other prescription medications, such as metformin, losartan, and ranitidine. Please continue reading to find out more about Pfizer's Chantix recall and the FDA’s most recent update on the manufacturing of varenicline products in the U.S.

What adverse reactions can the anti-smoking drug Chantix cause?

The anti-smoking drug Chantix can often cause gastrointestinal side effects. Some patients taking this medicine report adverse events like nausea, vomiting, stomach pain, gas, heartburn, and constipation.

Apart from these stomach side effects, Chantix can cause abnormal, vivid dreams and sleep problems (insomnia).

Why was the smoking cessation drug Chantix recalled?

Chantix 0.5 mg and 1 mg tablets were recalled due to the presence of a nitrosamine compound called N-nitroso-varenicline at or above the Food and Drug Administration (FDA’s) acceptable intake limit. 

What are the risks associated with N-nitroso-varenicline?

During the routine quality assurance process by Pfizer, there was evidence of higher levels of nitrosamine in Chantix tablets. These levels are higher than the acceptable range established by the U.S. FDA guidelines. The FDA acknowledged the recall; however, the agency did not object to certain manufacturers distributing varenicline tablets. The agency was exercising regulatory discretion to help with this drug shortage, considering the consequences if people resumed the use of tobacco. 

Nitrosamines exist naturally in food and water at low levels; these chemicals are commonly found in cured meats, dairy products, vegetables, and even air. According to a statement by Pfizer, there is no immediate risk to patients taking these medications.  However, consuming higher levels of nitrosamines over a prolonged period of time can potentially increase your risk of cancer.

Pfizer voluntarily recalled Chantix out of an abundance of caution.  It is good to know that there have been no reports of harm to patients who have been taking Chantix. After the recall announcement, people who take Chantix are advised to contact their healthcare provider to discuss alternative treatment options. Healthcare professionals can contact Pfizer Medical Information if they have any questions or concerns. Indeed, experts agree that the health benefits of stopping smoking outweigh any potential increased cancer risk from nitrosamine.

As mentioned above, Pfizer has communicated that there is no immediate risk to patients taking Chantix. Also, the FDA is not advising people to stop using Chantix unless their healthcare providers prescribe a different smoking cessation treatment. Overall, per Pfizer, the benefit/risk profile of Chantix remains positive.  

Is Chantix available in the US at present?

Since June 2021, Pfizer has stopped production of Chantix (varenicline tablets). It is unclear how long this recall will last. The company plans to perform more testing before resuming production with the impurity at acceptable levels.

To prevent any drug shortage, the FDA allowed alternative suppliers, such as a Canadian manufacturer called Apotex, to import Apo-Varenicline (the generic of Chantix) temporarily in the US to address the Chantix shortage. 

Remember that smoking can increase your risk of lung disease, cardiovascular disease, and many cancers. That’s why if you do not have access to Chantix, it’s important to discuss a different treatment with your doctor and continue your attempt to quit smoking.

What should I do with my Chantix tablets?

If you are taking Chantix, you should consult your healthcare provider with any medical questions about treatment alternatives. 

If you want to report adverse effects or product complaints, you should call Pfizer Drug Safety at 800-438-1985 and choose option 1; this toll-free line is available 24 hours a day, 7 days a week. 

If you are unsure how to dispose of your unused Chantix, you can reach out to your local pharmacy; you should be able to return the recalled Chantix to the pharmacy where you received this medication. 

Be sure to keep an eye on the FDA’s MedWatch page for updated information on the Chantix recall. 

Is it safe to take Chantix after the recall?

In May 2022, the FDA said it is now confident in U.S. manufacturers’ ability to supply varenicline with impurity levels at or below the acceptable intake limit. 

Chantix has a good safety profile over the past 15 years since it received marketing authorization. Pfizer believes the benefits of taking Chantix outweigh the potential increased risk of cancer. To date, there have been no reports of adverse events related to the Chantix recall. However, it is always the best practice to discuss any concerns or side effects with your healthcare team.

References:

1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-all-lots-chantixr-varenicline-tablets-due-n
2. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix

https://www.formularywatch.com/view/fda-approves-generic-of-chantix-pfizer-s-smoking-cessation-drug