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FDA seeks to remove all Zantac heartburn drugs from market

The Food and Drug Administration (FDA) is requesting that all prescription and over-the-counter versions of the heartburn drug ranitidine, known by the brand name Zantac, be immediately withdrawn from the market due to the presence of the probable human carcinogen NDMA.

“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” the FDA said in a news release.

During the summer of 2019, independent pharmacy Valisure informed the FDA of testing that revealed NDMA in some ranitidine products. NDMA is a considered a probable cancer-causing impurity. It is found in low levels in the environment and is commonly ingested in the diet. Low levels are not considered a cancer risk to humans. FDA conducted tests on ranitidine last fall and found low levels of NDMA in products it tested. But at that time the agency said that it did not have enough scientific evidence to recommend that consumers stop using it.

However, new testing from the FDA and evaluation prompted by information gathered by third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and increase significantly in samples stored at higher temperatures, including temperatures the product may have been exposed to during distribution and handling by consumers. The older the ranitidine was, the longer the length of time since it was manufactured, and the greater the level of NDMA. “These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” the FDA said.

Previous studies have found that it is also possible that medicines containing ranitidine can cause NDMA to form in the body after ingestion.

The FDA also tested and did not find NDMA in other classes of heartburn medications, such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole).

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