FDA Wants All Zantac Products Pulled; Probable Carcinogen Levels Increase During Storage
On Sept. 13, 2019, the FDA warned that some ranitidine medicines, including Zantac, contain low levels of NDMA, a probable human carcinogen.
On April 1, 2020, the U.S. Food and Drug Administration (FDA) asked that all ranitidine medicines, including the medicine commonly known as Zantac, be taken off the market.
The FDA made the request because these common heartburn medicines contain a compound called N-nitrosodimethylamine (NDMA), a probable carcinogen (substance that can cause cancer). The latest research results show that levels of NDMA in ranitidine medicines increase over time and when stored at higher-than-room temperature. This means that people taking the medicine may be exposed to unacceptable levels of NDMA.
The FDA also is recommending that people taking ranitidine medicines stop taking the medicines and ask their doctors about other medicines to treat their symptoms.
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.
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.
Why the FDA wants ranitidine medicines off the market
According to the FDA, unacceptable levels of NDMA were not found in all the ranitidine medicines tested.
“However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
FDA testing found that NDMA levels increase over time in ranitidine medicines, even when the medicines are stored in normal conditions. The testing also found that levels of NDMA increased dramatically in samples stored at higher temperatures, including temperatures the medicines may be exposed to during shipping. The testing also showed that the older a ranitidine medicine is, the higher the level of NDMA.
What this means for you
If you’re taking Zantac or another ranitidine medicine to control heartburn or treat stomach ulcers, the FDA advises that you stop taking the medicine immediately and dispose of it properly.
In light of the COVID-19 pandemic, the FDA recommends that you don’t take the medicine to a drug take-back location. Instead, read the disposal instructions in the medicine’s package insert or follow the FDA’s recommendations on safe disposal.
There are other medicines approved for the same or similar uses as ranitidine medicines that do not have NDMA risks, including Pepcid (chemical name: amotidine), Tagamet (chemical name: cimetidine), Nexium (chemical name: esomeprazole), Prevacid (chemical name: lansoprazole) and Prilosec (chemical name: omeprazole).
So it makes sense to ask your doctor about switching to a different medicine if you would like to continue to treat your symptoms.
Editor’s Note: This article was updated on April 1, 2020, with new safety information from the FDA.
Written by: Jamie DePolo, senior editor
Reviewed by: Brian Wojciechowski, M.D., medical adviser
— Last updated on February 22, 2022, 9:58 PM
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