Acceptable ARB Nitrosamine Impurity Levels

FDA has published interim acceptable levels of nitrosamine impurities in angiotensin II receptor blockers (ARBs) for manufacturers to use to ensure that finished drug products are safe for patients. An agency notice says FDA evaluated safety data for N-nitrosodiemthylamine (NDMA) and N-nitrosodiethylamine (NDEA) to determine an interim acceptable intake level for the impurities in the ARB class of drugs.

“Drug products that contain NDMA or NDEA above the limits in the table below pose an unacceptable risk to patients,” the notice says. “The agency will use the interim limits to recommend manufacturers conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in finished drug product.”

The agency says it is aware of NDMA and NDEA in certain valsartan-, irbesartan-, and losartan-containing products, and those products and some active pharmaceutical ingredients used to manufacture then have been recalled from the U.S. market.