FDA asks manufacturers to pull Zantac products amid cancer concerns

FDA asks manufacturers to pull Zantac products amid cancer concerns
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The Food and Drug Administration (FDA) on Wednesday said it is requesting the withdrawal of all prescription and over-the-counter ranitidine, a medication sold under the brand name Zantac for treatment of ulcers and acid reflux, over concerns about an impurity that may increase over time above room temperature.

The impurity, N-Nitrosodimethylamine (NDMA), is listed as a probable human carcinogen if ingested in "unacceptable" amounts, although people commonly consume it in lower levels in food and water.

“We didn't observe unacceptable levels of NDMA in many of the samples that we 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," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

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"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,” she added.

The agency is sending all ranitidine manufacturers letters requesting they withdraw the products from the market, according to the FDA, and also advising consumers to stop taking the products in tablet and liquid form.

The agency noted that other products cleared for similar usage include famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

“In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home,” the agency noted.