A new study published in the journal Chemical and Pharmaceutical Bulletin shows that storage conditions impact the level of the carcinogen NDMA produced in Zantac. N-nitrosodimethylamine, or NDMA, exists in low levels in the environment and is commonly ingested in the diet. When ingested at low levels, NDMA is not considered a cancer risk to humans. However, in June 2019, independent pharmacy Valisure found dangerously high levels of NDMA during routine testing of Zantac. Research conducted by Valisure and others showed that NDMA contamination in ranitidine is caused by the “‘inherent instability’” of the ranitidine molecule.
As a result, the U.S. Food and Drug Administration (FDA) requested manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market in April 2020.
In August 2020, researchers from the National Institute of Health Sciences in Japan published an article studying the impact of high-temperature storage conditions on ranitidine (Zantac). They found that under higher temperatures, the amount of NDMA in two different brands of ranitidine increased significantly from 0.19 to 116 ppm and from 2.89 to 18 ppm respectively. Additionally, the researchers found that other environmental factors, such as oxygen and moisture levels, impacted the level of NDMA formed in ranitidine. Based on their findings, the researchers discussed the importance of controlling and monitoring storage conditions in order to reduce the potential of NDMA-related health risks.
This story appears in the November 2020 issue of The Jere Beasley Report. For more like this, visit the Report online and subscribe.