N-nitrosodimethylamine (NDMA) Contamination of Ranitidine Products: A Review of Recent Findings

Fahad S. Aldawsari^*, Yahya M. Alshehry, Thamer S. Alghamdi

Saudi Food and Drug Authority (SFDA), 12843-7116 Riyadh, Saudi Arabia

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.

Keywords: NDMA, Ranitidine, US FDA, Drug contamination, LC-MS

https://doi.org/10.38212/2224-6614.1133

(https://www.jfda-online.com/journal/vol29/iss1/3)