The U.S. Food and Drug Administration (FDA) announced its request for the removal of Zantac products from drugstore shelves.
In a press release, the FDA called for the withdrawal of “all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.” This decision is part of the current investigation of a contaminant known as N-Nitrosodimethylamine in ranitidine medications, commonly known as Zantac, which are often used to treat heartburn.
N-Nitrosodimethylamine, or NDMA, is a chemical that, when exposed to light, can emit toxic fumes of nitrogen oxides when heated to decomposition, according to the U.S. National Library of Medicine. It is primarily used to develop tumors in laboratory animal specimens, and can occur naturally. It is sometimes found in cured meat products. While low levels are safe to consume, it is “reasonably anticipated” to be a carcinogen at higher levels, per the National Library of Medicine.
The FDA found traces of NDMA in some samples of Zantac above the acceptable daily intake limit, with the amount increasing as more time passes since the drug was manufactured and when stored under high temperatures.
The same tests also identified risks of toxic chemical exposure when taking Zantac even when the drug is stored under normal temperatures.
Such results have pushed the FDA to request the removal of all ranitidine drugs from the market. Consumers are advised to stop taking any ranitidine tablets or liquids and to dispose of them properly and not buy more.
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“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. 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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research in the press release.
As a result of the FDA’s action, new sales of Zantac won’t be allowed.
Patients taking prescription ranitidine medicines should consult their health care providers about alternative treatment options, as some FDA-approved drugs can be used as substitutes. Researchers have currently not found NDMA in other drugs like famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
“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.”
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