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, Walgreens and Kroger 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.
https://www.marketscreener.com/news/FDA-Recommends-Against-Using-Certain-Test-on-Ranitidine-Says-it-May-Generate-NDMA-in-Sample–29327990/
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