New FDA data is prompting the agency to request removal of all Zantac and other ranitidine products from stores. This product is contaminated with N-Nitrosodimethylamine (NDMA), which is a probable human carcinogen. Public health officials have found that the impurity in some ranitidine products increases over time, especially when the drug is stored at higher than room temperatures. Rantidine products will no longer be available for over-the-counter or prescription purchase in the U.S. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research said in a statement, "The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the … [Read more...]
FDA Warns Consumers About Nitrosamines in Zantac
The FDA is warning consumers about a nitrosamine compound called NDMA, or N-Nitrosodimethylamine, also known as dimethylnitrosamine (DMN), which is an ingredient in a heartburn drug called Zantac. The company that makes this drug, which is sold through prescription and also over-the-counter, has recalled all Zantac OTC in the United States. The first statement by the FDA about this issue was issued on September 13, 2019. At the time, they were investigating impurities in blood pressure and heart failure medicines, and recommended numerous recalls of those types of products. The FDA asked companies that produce ranitidine medications, including Zantac, to conduct testing on their products. There are inconsistencies in preliminary set results of this ingredient in Zantac products, … [Read more...]
