According to a notice posted on the Food and Drug Administration (FDA) website, giant pharmaceutical company, in the news for its COVID-19 mRNA vaccine with German BioNTech, Pfizer is recalling all lots of 0.5 mg and 1 mg varenicline tablets. The notice declares that long term ingestion of the drug might have a potential cancer risk, since it contains high levels of nitrosamines although there is no immediate risks to those who are currently on the medication.
On Friday, the FDA posted an update to the above notice which said that patients who were already taking these tablets should continue to do so until they are provided with a replacement by their pharmacists or until they are provided with an alternative treatment by their doctor.
The U.S. pharmaceutical had already recalled a few lots of the tablets with the brand name “Chantix” in July. The tablets were distributed in the nation and in Puerto Rico The number of lots recalled were increased in August and include the following batches:
- 00019213
- EC6994
- EA 6080
- EC9843
- 00020231
- 00020232
- 00020357
- 00020358
- 00020716
- ET1600
- ET1607
- – ET1609
Nitrosamines are naturally occurring organic compounds. They are found in many foods including meat, dairy, and vegetables as per the FDA website. Every person might have been exposed to ingesting these compounds. However, large amounts of these compounds could increase the risk of a person developing cancer.
However, Pfizer also said that people who smoke cigarettes can develop lung cancer about 15 to 30 times more often than non-smokers.
Three years ago, other medications including drug for high blood pressure, were found to have excess levels of nitrosamines. The FDA has set permissible levels of these organic compounds. When levels cross these limits, products including drugs have to be recalled.
According to a report by Bloomberg, the FDA had found nitrosamines in high levels in metformin, a common drug that is used to treat diabetes. In 2019, Zantac, a tablet used to treat heartburn, manufactured by Sanofi SA, was recalled as it had high levels of nitrosamines.
Pfizer, which gained FDA approval for Chantix to be used as a smoking cessation drug said that the recall was a voluntary effort by the company.
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