FDA looking into possible carcinogen found in Zantac, other heartburn medications

LOS ANGELES - The U.S. Food and Drug Administration announced Friday that it is looking into a trace amount of cancer-causing chemicals found in heartburn medications such as Zantac.

The agency said it learned ranitidine medications, which are over-the-counter and prescription drugs meant to lower acid in the stomach, contained low levels of an impurity called N-nitrosodimethylamine (NDMA).

NDMA is classified as a possible carcinogen based on laboratory test results, according to the FDA. The chemical often contaminates water and food, such as meat, dairy products and vegetables.

The FDA said it has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medications called Angiotensin II Receptor Blockers since 2018. In those cases, the FDA issued numerous recalls because the levels were “unacceptable.”

Now the FDA is evaluating whether the low levels of NDMA found in the heartburn medications pose a risk to users.

“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,” the agency said in a press release.

FDA officials are working with international regulators and people within the industry to determine the source of the NDMA.

While the FDA is not currently urging users to stop taking the medications, officials suggest that anyone using prescription forms of ranitidine who want to stop should ask their doctors about other treatment options.

As for people taking over-the-counter versions of the medications, they can use other heartburn medicines that have not been found to contain NDMA.

The agency urges consumers and health care professionals to report any symptoms or side effects they may experience while taking the medications to the FDA MedWatch program.