Concerns over ongoing recalls of angiotensin II receptor blockers (ARBs) are forcing physicians and patients to choose between optimal treatments and rattling confidence in the safety of the generic drug supply itself.
"I see hypertension on a regular basis and on any given clinic day, four to five patients have either stopped their medicines or have considered stopping their medicines and a separate detailed conversation has to be put in place to try to convince them to continue," Keith Ferdinand, MD, Tulane University Heart and Vascular Institute, New Orleans, told theheart.org | Medscape Cardiology.
ARBs are recommended for the treatment of hypertension, heart failure, and chronic kidney disease, with more than 61 million prescriptions written for valsartan, losartan, and irbesartin in the United States in 2016, according to the federal ClinCalc DrugStats database.
Ongoing US Food and Drug Administration (FDA) recalls — all in generic ARB-containing products — began last July when the probable carcinogen N-nitrosodimethylamine (NDMA) was detected in the valsartan active pharmaceutical ingredient (API) supplied by Zhejiang Huahai Pharmaceuticals (ZHP), Linhai, China.
Within months, the rolling recalls had extended to irbesartan- and losartan-containing products. A second probable carcinogen, N-nitrosodiethylamine (NDEA), was identified last fall and a third, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), only last month.
