New Guidance on Acceptable NDMA and NDEA Levels in ARBs

December 20, 2018 – The U.S. FDA has issued new guidance on the acceptable level of nitrosamine impurities in angiotensin II receptor blockers (ARBs). A number of companies issued recalls in 2018 related to the presence of nitrosamine compounds in their ARB products, which have included valsartan, losartan, and irbesartan.

In each of the 2018 recalls of ARBs due to nitrosamine compounds, the affected drug products were found to contain N-Nitrosodimethylamine (NDMA) and/or N-Nitrosodiethylamine (NDEA). FDA investigations determined that these impurities were most likely a result of the manufacturing process. A full list of the recalled products to date can be found at: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf

NDMA and NDEA are considered probable human carcinogens, or cancer-causing agents, but are not believed to present a significant risk when exposure remains limited. The FDA’s new interim limits on these compounds are designed to safeguard patient health. The full list of new interim limits, as well as other updates on ARB recalls and safety, can be found at: https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm