The U.S. Food and Drug Administration (FDA) has issued a statement informing patients and health care providers that some ranitidine medicines – including certain products commonly known as the brand-name drug Zantac – contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).

NDMA is a known environmental contaminant classified as a probable human carcinogen and is commonly found in water and foods, including meats, dairy products, and vegetables. According to preliminary tests, the FDA described the levels found in the studied ranitidine products as "barely exceeding" those found in common foods, and is not calling for patients to stop taking ranitidine products at this time.

The FDA said it is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and that it will share that information when available. Read the full statement here.

In the meantime, Novartis announced that it has halted distribution of Zantac as a precaution. Concerned patients can speak with their health care provider about the other drug options available for their condition.

Keywords: ACC Advocacy, Dimethylnitrosamine, Ranitidine, United States Food and Drug Administration, Nitrosamines, Carcinogens

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