FDA Says Some Heartburn Drugs May be Linked to Cancer

The U.S. Food and Drug Administration (FDA) warned that some heartburn drugs, including Zantac® (ranitidine), contain low levels of N-nitrosodimethylamine (NDMA), a nitrosamine impurity that is classified as a probable human carcinogen that could cause cancer.

NDMA is a known environmental contaminant that is found in water and foods, including meats, dairy products, and vegetables. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure drugs since last year, for which the FDA has recommended numerous recalls for medications with unacceptable levels of nitrosamines.

No recalls yet—more research needed

The FDA is still evaluating whether the low levels of NDMA found in ranitidine pose a risk to patients. So far, the agency said that the level of NDMA in these products is very low, and at this time, there have been no recalls. Ranitidine is available over the counter (OTC) and as a prescription to decrease the production of stomach acid.

“The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their healthcare professional about other treatment options,” the FDA said in a press release. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition.”

The European Medicines Agency is also reviewing ranitidine medicines. The FDA said it is working with international regulators and industry partners to determine the source of this impurity in ranitidine.