FDA Recommends Against Using Certain Test on Ranitidine, Says it May Generate NDMA in Sample
October 02 2019 - 4:26PM
Dow Jones News
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
October 02, 2019 16:11 ET (20:11 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Kroger (NYSE:KR)
Historical Stock Chart
From Aug 2024 to Sep 2024
Kroger (NYSE:KR)
Historical Stock Chart
From Sep 2023 to Sep 2024