GAITHERSBURG, MD. -- The majority of two Food and Drug Administration advisory panels voted at a Sept. 11 meeting against the agency's proposal to set a hemoglobin target of about 11 g/dL in chronic renal failure patients being treated with erythropoiesis-stimulating agents.
At a joint meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panelists voted 14 to 5 against changing the labels of erythropoiesis-stimulating agents (ESAs) to state that hemoglobin levels should not exceed about 11 g/dL when treating patients with chronic renal failure who are on dialysis. They also voted 14 to 5 against ...