Statement on New Testing Results, Including Low Levels of Impurities in Ranitidine Drugs

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  4. Statement on New Testing Results, Including Low Levels of Impurities in Ranitidine Drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives. Helping assure the quality and safety of these products is one of our greatest responsibilities. Over the past several weeks, the FDA has been investigating the detection of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, commonly known by the brand name Zantac.

We set out to fully understand this issue and provide actionable information for Americans who use these medications. The information we’ve gathered as part of our ongoing ranitidine investigation has been vital to answering the questions we’ve received about the potential risk of these products. Throughout this process, we’ve been updating our website with new information, and we are again providing an update with the latest information.

The agency has tested numerous ranitidine products on the market over the past few months, and today we’re releasing a summary of the results we have to date. Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats. We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process. Similarly, if ranitidine is exposed to a simulated small intestine environment, NDMA is not formed. However, we still must test the drugs in the human body to fully understand if ranitidine forms NDMA.

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