Hypertension Hot Potato - Anatomy of the Angiotensin-Receptor Blocker Recalls

Angiotensin-receptor blockers (ARBs) are one of four drug classes recommended for the initial treatment of hypertension. These medications are commonly used not only for hypertension — a condition present in 45.6% of U.S. adults — but also for heart failure and chronic kidney disease. On January 25, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Director of the FDA Center for Drug Evaluation and Research Janet Woodcock released a statement updating the public on large-scale voluntary recalls of various products containing ARBs. 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. These recalls are of growing concern to patients, clinicians, and organizations delivering primary care or complex, multidisciplinary health care, and they highlight several issues related to the readiness of our health systems to respond to drug recalls, trust between patients and providers, uncertain drug-dose equivalences, and the regulation of drug manufacturing in the global marketplace…

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