Several different medicines have been recalled in recent years due to cancer-causing impurities. Certain types of blood pressure, diabetes, and heartburn medications were included in these recalls. Recently, another type of medication has been voluntarily recalled by the manufacturer.
What is varenicline?
Varenicline is a prescription medication, also known under the brand name Chantix®. Chantix® is a medication used to help people stop smoking. Chantix® is intended to be used for a short period of time.
A well-established fact is that smoking in and of itself is associated with an increased risk of cancer. People who smoke cigarettes are fifteen to thirty times more likely to get lung cancer compared to those who do not smoke.
Why was it recalled?
The drug manufacturer, Pfizer, voluntarily recalled twelve different lots of Chantix® in various strengths in July 2021. This recall was due to the finding of a nitrosamine substance, N-nitroso-varenicline. Nitrosamines are common in water and foods and most everyone is exposed to nitrosamines in their lifetime. However, it is when people are exposed to nitrosamines above acceptable levels over long periods of time that there may be an increased risk of cancer. Pfizer decided to recall the lot due to finding a level of nitrosamine above their established acceptable daily intake level. Nitrosamines can come from the manufacturing process, the chemical structure of the medicine, or storage or packaging conditions. These impurities are being identified more frequently now due to the availability of newer technology and testing methods, which make it easier to test for impurities.
What should you do if you’re taking Chantix®?
If you are currently taking Chantix®, talk with your healthcare provider or pharmacist to find out if you have an affected lot. The recall has been established under the utmost caution to avoid something that is known to potentially be harmful, but there are no urgent risks to people taking varenicline at this time. So far, there have been no reports of adverse events that have been related to this recall. If you are taking an affected lot of varenicline, talk with your healthcare provider about an alternative.
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For more information or for a full list of the specific products recalled see the FDA’s post sharing Pfizer’s announcement here: Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content | FDA