Abstract
Recently the manufacturers of darbepoetin alfa (Aranesp), epoetin alfa (Epogen, Procrit) in collaboration with the Food and Drug Administration (FDA) released updated product information that includes a black box warning regarding the safety of erythropoietic-stimulating agents (ESAs). A higher chance of serious and life-threatening side effects or death with the use of ESAs was noted in 4 recent surgical studies and 2 studies in persons with chronic kidney disease when targeting hemoglobin values 12 g/dL. As a result, Amgen and Ortho Biotech cooperated with the FDA to examine safety signals from these studies and arrive at the following black box warning.
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