November 1, 2019, the U.S. Food and Drug Administration (FDA) released an article outlining the studies they have been conducting with ranitidine, a medication more commonly known by the brand name Zantac. The FDA has been investigating the detection of a contaminant known as N-Nitrosodimethylamine (NDMA) in Zantac. The studies are currently ongoing but the drug has currently been recalled while the FDA is concluding their studies.
The FDA says that the levels of NDMA found during their testing are much lower than the levels some third-party scientists first claimed, however some levels still exceed what the FDA considers acceptable for these medicines. The initial studies were conducted in environments simulating the stomach and small intestine but further studies are now being conducted in the human body to fully understand if ranitidine forms NDMA.
In the meantime, our recommendations for consumers and patients have not changed. Consumers taking OTC ranitidine or nizatidine can consider using other OTC products approved for their condition. So far, the FDA and industry testing of medicines in the histamine-2 (H2) blocker and proton pump inhibitor (PPI) classes have identified NDMA only in ranitidine and nizatidine. The FDA’s tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA impurities in the medicines. Patients that are taking prescription ranitidine products should speak with their health care professional about other treatment options. To read the full article or to find more information please visit the links below.