Department of Pediatrics, Division of Pediatric Gastroentrology; UMass Memorial Children's Medical Center
Health Policy | Pharmacy Administration, Policy and Regulation
N-nitrosodimethylamine (NDMA), a probable human carcinogen, was discovered decades ago, although elevated levels in several widely used drugs were detected only recently. Several medications that are now known to contain NDMA have remained available, whereas ranitidine has been completely withdrawn from the market. In the following paper, we discuss the overview of events that led to the withdrawal of ranitidine and compare evidence and subsequent regulatory response of other medications also containing NDMA.
N-nitrosodimethylamine, NDMA, ranitidine
Rights and Permissions
Copyright © 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
DOI of Published Version
Wagner JA, Dinh JC, Lightdale JR, Gold BD, Colombo JM. Is this the end for ranitidine? NDMA presence continues to confound. Clin Transl Sci. 2021 Jul;14(4):1197-1200. doi: 10.1111/cts.12995. Epub 2021 May 2. PMID: 33934515; PMCID: PMC8301580. Link to article on publisher's site
Clinical and translational science
Wagner JA, Dinh JC, Lightdale JR, Gold BD, Colombo JM. (2021). Is this the end for ranitidine? NDMA presence continues to confound. Open Access Publications by UMass Chan Authors. https://doi.org/10.1111/cts.12995. Retrieved from https://escholarship.umassmed.edu/oapubs/4721
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License