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Some Zantac Tainted With Low Levels of Carcinogen

Nitrosamine Impurity Also Affects Other Ranitidine Drugs

Certain ranitidine medications used to treat heartburn—including some products sold under the brand-name Zantac (Sanofi)—contain low levels of a nitrosamine impurity linked with cancer, the FDA says.

The contaminant, N-nitrosodimethylamine (NDMA), is classified as a probable human carcinogen based on laboratory tests, says Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research. Ranitidine is available over the counter (OTC) and by prescription. A histamine-2 blocker, it decreases the amount of acid created by the stomach. OTC ranitidine is used to prevent and relieve heartburn, while prescription ranitidine’s multiple indications include treating and preventing ulcers of the stomach and intestines and treating gastroesophageal reflux disease.

“The FDA is not calling for individuals to stop taking ranitidine at this time,” Dr. Woodcock says. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called angiotensin II receptor blockers (ARBs) since last year. The FDA has recommended numerous ARB recalls as it discovered unacceptable levels of nitrosamines.

“The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients,” Dr. Woodcock says. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.” NDMA, a known environmental contaminant, is found in water, meats, dairy products, and vegetables.

The FDA is investigating the source of the ranitidine impurity. The agency pledged to “take appropriate measures based on the results of the ongoing investigation.”

Source: FDA, September 13, 2019

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