What carcinogenic chemical was found in Zantac, the most popular brand of ranitidine?
The U.S. FDA last fall reported that some medications, including some products commonly known as the brand-name drug Zantac, contain a potentially dangerous chemical, NDMA (scientific name N-Nitroso-dimethylamine) at unsafe levels. Nitrosodimethylamine, classified as a probable human carcinogen based on the results of laboratory tests, is a semi-volatile organic chemical that can form naturally through industrial processes. NDMA was formally used in aviation and rocket fuel and industrial lubricants. It can also be found in water as well as meat, dairy, and vegetables.
During its routine testing of every batch of every medication, Valisure, America’s first analytical pharmacy to chemically validate medications and ensure their quality and safety, discovered the link of Zantac and its generics to the carcinogen NDMA, and first notified the FDA of its initial findings in June of 2019. The online pharmacy based in Connecticut, also claimed that the NDMA is likely formed as the result of the inherent instability of the ranitidine molecule. Although the FDA advisory states that the level of contamination is “low,” Valisure has detected NDMA in excess of 3,000,000 ng per tablet, a level likely much higher than what the agency has determined to be reasonably safe for human ingestion based on lifetime exposure.
Ranitidine, the active ingredient in Zantac, has a molecular structure that makes it susceptible to naturally creating NDMA once it is ingested. The ranitidine molecule contains nitrite and dimethylamine, two elements well known for producing NDMA under the right conditions. Specifically, when the ranitidine interacts with the gastric fluid and sodium nitrites found in the stomach, high amounts of NDMA are produced.