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FDA Warns About Probable Carcinogen in Zantac

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On Sept. 13, 2019, the U.S. Food and Drug Administration (FDA) warned that some ranitidine medicines, including the medicine commonly known as Zantac, contain very low levels of a compound called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen based on lab testing.

Read the FDA statement.

The manufacturer of Zantac, a division of Novartis, has reportedly decided to halt distribution of the drug until the issue is resolved.

About ranitidine medicines

Ranitidine medicines decrease the amount of acid made in your stomach. The medicines are commonly used to treat stomach ulcers and heartburn, which is also called gastroesophageal reflux disease, or GERD. Some brand names of ranitidine are Zantac and Tritec.

About NDMA

NDMA can get into drinking water when dimethylhydrazine, a component of rocket fuel, breaks down. NDMA also is a byproduct of some industrial processes, and it is an ingredient found in certain pesticides. The World Health Organization classifies NDMA as a probable human carcinogen, which means that the compound may cause cancer in people if it is present at high enough levels.

In 2018, the FDA warned about NDMA in certain blood pressure medicines, called angiotensin II receptor blockers, which led to the recall of a number of the medicines containing valsartan, losartan, or irbesartan.

About the warning

According to the FDA, the levels of NDMA found in the ranitidine medicines were very low, apparently lower than the levels of NDMA found in the blood pressure medicines that were recalled.

“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.”

According to the statement, “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 health care professional about other treatment options. People taking [over-the-counter] ranitidine could consider using other [over-the-counter] medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

So while the FDA isn’t saying you should stop taking a ranitidine medicine, it is saying that you may want to consider a different medicine to treat heartburn, ulcers, or other problems related to stomach acid. Some other medicines include Axid (chemical name: nizatidine), Pepcid (chemical name: famotidine), and Tagamet (chemical name: cimetidine).

What this means for you

If you’re taking Zantac or another ranitidine medicine to control heartburn or treat stomach ulcers, it makes sense to ask your doctor about the FDA warning and whether you should switch to a different medicine.

It’s good to know that the levels of NDMA in ranitidine medicines are very low. According to the FDA, it’s unlikely that this level of NDMA would increase your risk of developing cancer.

The FDA said it will release updates as more information becomes available.

Written by: Jamie DePolo, senior editor

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