FDA Recommends Against Using Certain Test on Ranitidine, Says it May Generate NDMA in Sample

   By Stephen Nakrosis 
 

The U.S. Food and Drug Administration on Wednesday said a method of testing the drug ranitidine for impurities is not suitable to detect the presence of NDMA, a possible carcinogenic, because the testing method may generate NDMA.

According to the agency, a testing method employing high temperatures "generated very high levels of NDMA from ranitidine products because of the test procedure." That method was used by a third-party laboratory, whose work was observed by the FDA.

The FDA said a liquid chromatography-high resolution mass spectrometry, or LC-HRMS, method should be used to test for the presence of NDMA. "FDA's LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory."

The agency said it is continuing tests of ranitidine products from a number of manufacturers, and is asking ranitidine manufacturers to send samples of their products to the agency for testing by FDA scientists.

Ranitidine is used to treat heartburn and other gastrointestinal disorders.

The FDA last month said it detected low levels of NDMA, a probable carcinogenic, in the heartburn treatment Zantac. Ranitidine is an active ingredient in Zantac.

Since then, a number of retailers, including Walmart Inc. (WMT), Walgreens (WBA) and Kroger Co. (KR) have removed treatments containing ranitidine from their shelves.

In a release last month, the FDA notified professionals and patients about the voluntary recall, but said not all ranitidine medicines are being recalled, and added it wasn't recommending individuals stop taking all ranitidine medicines.

--Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

October 02, 2019 16:11 ET (20:11 GMT)

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