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, so the company is voluntarily recalling these products as the investigation is proceeding. Apotex is also recalling ranitidine out of an abundance of caution. Dr. Reddy’s Laboratories recalled their products on October 23, 2019, and Sandoz recalled their products on September 23, 2019. Perrigo recalled their ranitidine products on October 23, 2019
The problem is that NDMA is classified as a probable human carcinogen based on laboratory tests. NDMA is an environmental contamination and is found in foods and water, including meats, dairy products, and vegetables.
Not all ranitidine medicines marketed in the U.S. are being recalled. The FDA has tested some of these medications. They found that Pepcid, Tagamet, Nexium, Prevacid, and Prilosec contain no NDMA. Consumers taking OTC ranitidine products should consider buying other products marketed for this condition.
But the FDA statement is that the government does not have scientific evidence to recommend whether or not consumers should stop taking ranitidine medications at this time and is conducting more tests. If you take ranitidine as a prescription medication, talk to your doctor. But if you are taking one of the recalled medicines, stop using it.
The FDA has recently posted a testing method that can be used by regulators and industry to detect nitrosamine impurities in ranitidine.
If you have taken any of these types of products and have experienced adverse effects, you can report them through the FDA’s MedWatch Adverse Event Reporting System, either online or by fax.
