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Research Letter
January 7, 2020

Changes in Utilization of Generic Angiotensin Receptor Blockers Following Product Recalls in the United States

Author Affiliations
  • 1Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts
JAMA. 2020;323(1):87-89. doi:10.1001/jama.2019.17521

Angiotensin receptor blockers (ARBs) are one of the most common prescription drug classes, used by 5.8% of adults in the United States in 2011-2012 for treatment of hypertension, heart failure, and diabetic nephropathy.1 Discovery of potentially carcinogenic nitrosamine impurities (N-nitrosodimethylamine, N-nitroso-N-diethylamine, and N-nitroso-N-methyl-4-aminobutyric acid ) in generic ARBs resulted in recalls of multiple lots of valsartan, losartan, and irbesartan from different manufacturers. As of August 8, 2019, the US Food and Drug Administration (FDA) reported recalls of 139 valsartan, 57 losartan, and 16 irbesartan national drug codes (NDCs).2 National drug codes are unique product identifiers that have 3 segments that encode the labeler (eg, manufacturer or repackager), the specific drug, and the packaging information (eg, bottle size). Manufacturers typically produce many lots of the same NDC. Although the FDA noted that the potential cancer risk posed by exposure to ARB products with nitrosamine impurities is very small and advised patients to continue taking their current medications until consulting their physician,3 recalls have led to concern and confusion among patients, physicians, and pharmacists.4 We assessed prescription dispensing patterns for ARBs to evaluate whether recalls shifted the utilization of ARBs, individually and as a class. Furthermore, we evaluated dispensing patterns for recalled NDCs to estimate the size of the patient population with potential exposure to impurities.

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