In September 2019, the probable carcinogenN-nitrosodimethylamine (NDMA) was discovered in ranitidine products from a number of manufacturers, resulting in recalls.[14][15][16][17] In April 2020, ranitidine was withdrawn from the United States market and suspended in the European Union and Australia due to these concerns.[18][19][20][11][21][22]
In 2022, these concerns were confirmed in a Taiwanese nationwide population study finding "significant trends of increased liver cancer risk with an increasing dose of ranitidine" (up to 22% higher than control) and increased gastric, pancreatic, lung[b] and overall[c] cancer risk.[23]
Ranitidine was discovered in England in 1976, and came into commercial use in 1981.[26] It is on the World Health Organization's List of Essential Medicines.[27][28][29] It has been withdrawn at regulator request from most markets, including the United States;[12] according to the UK NHS, it has been discontinued globally.[30]
^"FDA updates and press announcements on NDMA in Zantac (ranitidine)". U.S. Food and Drug Administration (FDA). 28 October 2019. Archived from the original on 29 October 2019. Retrieved 28 October 2019. FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. The FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA. FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine. 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. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples. This article incorporates text from this source, which is in the public domain.
^World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
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