FDA: Zantac May Contain Small Amounts of Known Carcinogen

Preliminary tests found low levels of N-nitrosodimethylamine in some ranitidine products

FRIDAY, Sept. 13, 2019 (HealthDay News) -- A substance that could cause cancer has been found in some ranitidine heartburn and ulcer medicines, including the brand-name drug Zantac, and the source of this contamination is being investigated, the U.S. Food and Drug Administration says.

While preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some ranitidine products, the FDA said it does not mean patients taking the drugs should stop using them now. NDMA is the same contaminant found in many brands of blood pressure and heart failure medicines during the past year, leading to recalls.

NDMA is an environmental contaminant found in water and foods, including meats, dairy products, and vegetables. It is classified as a probable human carcinogen. Large amounts of NDMA may pose a risk, but the levels of NDMA in ranitidine found in preliminary tests barely exceed amounts found in common foods, according to the FDA. The agency said it is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and that it will post that information when it is available.

Janet Woodcock, M.D., director of the FDA Center for Drug Evaluation and Research, said the FDA is working with international regulators and industry partners to find out where the contamination originated. "The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients," she said in a news release. "The FDA will take appropriate measures based on the results of the ongoing investigation."

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