Ranitidine is a medication that has been used to alleviate heartburn and other disorders for over 40 years. Following reports of N-nitrosodimethylamine (NDMA) contamination in ranitidine products, there have been many recalls and registration suspensions. Here, we revise the literature information confirming ranitidine association with NDMA. Then, we highlight the documented mechanisms for NDMA release from ranitidine. In addition, the stability issue for this medicine is discussed. After that, we review and discuss the results of the United States Food and Drug Administration and the Australian Therapeutic Goods Administration laboratory testing of ranitidine products and the detected NDMA levels. Finally, the case of NDMA generation in Angiotensin II Receptor Blockers (ARBs) and ranitidine were compared in an attempt to address the circumstances leading to the current contamination.
Aldawsari, Fahad S.; Alshehri, Yahya M.; and Alghamdi, Thamer S.
"N-nitrosodimethylamine (NDMA) Contamination of Ranitidine Products: A review of recent findings,"
Journal of Food and Drug Analysis: Vol. 29
, Article 3.
Available at: https://doi.org/10.38212/2224-6614.1133
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Medicinal and Pharmaceutical Chemistry Commons, Other Chemicals and Drugs Commons, Other Pharmacology, Toxicology and Environmental Health Commons, Other Pharmacy and Pharmaceutical Sciences Commons, Pharmaceutical Preparations Commons