12:00 AM
Nov 12, 2007
 |  BioCentury  |  Regulation

ESA label changes

ESA label changes

Label changes
Renal failure
Added in boxed warning: "Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL."
Added in warnings section: "Patients with chronic renal failure...

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