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FDA Looks Into Low Levels of Concerning Impurity in Zantac

No recall for now, FDA says
By Bob Cronin,  Newser Staff
Posted Sep 13, 2019 4:02 PM CDT
The Food and Drug Administration campus in Silver Spring, Maryland. The agency is considering whether to recall heartburn medications.   (AP Photo/Andrew Harnik, File)

(Newser) – The FDA is evaluating the risk to people who take Zantac and its generic versions after a probable carcinogen was found in the heartburn medication. N-nitrosodimethylamine, also known as NDMA, is the nitrosamine impurity detected in low levels, CNN reports. The agency has been investigating such impurities in blood pressure and heart failure medicines, and has issued recalls in the past. There's no recall for now in this case, though. Tests indicate the amount of NDMA in ranitidine, the generic name for the heartburn and acid-reducing drugs, might only slightly exceed the amounts found in foods such as meats and dairy products, per USA Today.

European agencies said at the same time that they're investigating, as well. The FDA had been alerted by Valisure, a US online pharmacy. Valisure, which tests the medications it sells, has asked the FDA to recall Zantac and the generics that have NDMA in them, per Bloomberg. Zantac is made by Sanofi. Valisure called the levels excessive, which the FDA disagrees with. "We don’t think this poses an immediate hazard to human health," an FDA spokesperson said, "so we’ll have an ongoing process to determine whether recalls are needed." (Read more Food and Drug Administration stories.)

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