Ranitidine: Difference between revisions

In September 2019, the probable [[carcinogen]] [[N-Nitrosodimethylamine|''N''-nitrosodimethylamine]] (NDMA) was discovered in ranitidine products from a number of manufacturers, resulting in recalls.<ref name="HealthCanada">{{cite web | date=13 September 2019 | title=Health Canada assessing NDMA in ranitidine | url=https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70989a-eng.php | url-status=live | archive-url=https://web.archive.org/web/20190926211206/https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70989a-eng.php | archive-date=26 September 2019 | access-date=26 September 2019 | website=[[Health Canada]]}}</ref><ref name="FDA2019NDMA">{{cite web | date=13 September 2019 | title=Statement alerting patients and health care professionals of NDMA found in samples of ranitidine | url=https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine | url-status=live | archive-url=https://web.archive.org/web/20190926210751/https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine | archive-date=26 September 2019 | access-date=26 September 2019 | website=U.S. [[Food and Drug Administration]] (FDA)}} {{PD-notice}}</ref><ref name="EMA1">{{cite press release | title=EMA to provide guidance on avoiding nitrosamines in human medicines | website=European Medicines Agency | date=13 September 2019 | url=https://www.ema.europa.eu/en/news/ema-provide-guidance-avoiding-nitrosamines-human-medicines | access-date=19 September 2019 | archive-date=31 December 2019 | archive-url=https://web.archive.org/web/20191231050132/https://www.ema.europa.eu/en/news/ema-provide-guidance-avoiding-nitrosamines-human-medicines | url-status=live}}</ref><ref name="FDA NDMA ranitidine">{{cite web | date=28 October 2019 | title=FDA updates and press announcements on NDMA in Zantac (ranitidine) | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine | url-status=live | archive-url=https://web.archive.org/web/20191029011848/https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine | archive-date=29 October 2019 | access-date=28 October 2019 | website=U.S. [[Food and Drug Administration]] (FDA) | quote=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.<br />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.}} {{PD-notice}}</ref> In April 2020, ranitidine was withdrawn from the United States market and suspended in the European Union and Australia due to these concerns.<ref name="FDA Q&A">{{cite web | date=11 October 2019 | title=Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac) | url=https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac | url-status=live | archive-url=https://web.archive.org/web/20191024040431/https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac | archive-date=24 October 2019 | access-date=23 October 2019 | website=U.S. [[Food and Drug Administration]] (FDA)}} {{PD-notice}}</ref><ref name="FDA removal PR">{{cite press release | title=FDA Requests Removal of All Ranitidine Products (Zantac) from the Market | website=U.S. [[Food and Drug Administration]] (FDA) | date=1 April 2020 | url=https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market | access-date=1 April 2020 | archive-date=28 March 2021 | archive-url=https://web.archive.org/web/20210328103217/https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market | url-status=live }} {{PD-notice}}</ref><ref name="EU suspension PR">{{cite press release | title=Suspension of ranitidine medicines in the EU | website=European Medicines Agency | date=30 April 2020 | url=https://www.ema.europa.eu/en/news/suspension-ranitidine-medicines-eu | access-date=2 June 2020 | archive-date=5 January 2021 | archive-url=https://web.archive.org/web/20210105083734/https://www.ema.europa.eu/en/news/suspension-ranitidine-medicines-eu | url-status=live }}</ref><ref name="CHMP withdrawl" /><ref>{{cite web | title=Ranitidine | website=Therapeutic Goods Administration (TGA) | date=2 April 2020 | url=https://www.tga.gov.au/node/882059 | access-date=19 July 2020 | archive-date=29 August 2021 | archive-url=https://web.archive.org/web/20210829025912/https://www.tga.gov.au/alert/ranitidine-0 | url-status=live }}</ref><ref name="2021NIH">{{cite journal | vauthors = Wagner JA, Dinh JC, Lightdale JR, Gold BD, Colombo JM | title = Is this the end for ranitidine? NDMA presence continues to confound | journal = Clinical and Translational Science | volume = 14 | issue = 4 | pages = 1197–1200 | date = July 2021 | pmid = 33934515 | pmc = 8301580 | doi = 10.1111/cts.12995 }}</ref>

 

 

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