Question - What is the basis for the recent recalls issued by the FDA regarding products containing angiotensin receptor blockers (ARBs)?
Answer- The cited article notes “Two probable carcinogens had been identified in active pharmaceutical ingredients used by some manufacturers of valsartan, irbesartan, and losartan. The impurities arose during manufacture of the ingredients in two factories located in China and India. The same day, the Wall Street Journal reported that as many as 2 million patients had probably been exposed to the impurities, N-methyl-d-aspartate (NDMA) and N-nitroso-N-diethylamine (NDEA). Most recently, a third impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), has been identified in an ARB product, resulting in a new recall.” (Byrd JB et al. Hypertension hot potato-Anatomy of the angiotensin-receptor blocker recalls. 2019 NEJM https://www.nejm.org/doi/full/10.1056/NEJMp1901657?query=featured_home)