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FDA adds more warnings to ESAs

June 25, 2011 1:58 AM UTC

FDA modified the black box warning and recommended more conservative dosing for erythropoiesis-stimulating agents (ESAs) used to treat anemia in chronic kidney disease (CKD) patients. The labels now warn that CKD patients in controlled trials experienced greater risks of death, serious adverse cardiovascular reactions and stroke when administered ESAs to target a hemoglobin level greater than 11 g/dL and that no trial has identified a target level, ESA dose or dosing strategy that does not increase the risks.

Previously, the labels recommended the use of ESAs to achieve and maintain a target range of 10-12 g/dL. The updated labels now specify dosing recommendations for dialysis and non-dialysis CKD patients and when dosing should be reduced or interrupted. For dialysis patients, FDA recommends starting ESAs when the hemoglobin level is less than 10 g/dL and reducing or interrupting the dose when levels are greater than 11 g/dL. For non-dialysis patients, initiation is recommended when the level is less than 10 g/dL in cases where the rate of hemoglobin decline indicates the likelihood of a red blood cell transfusion. Dose reduction or interruption is recommended when levels are greater than 10 g/dL. FDA also recommends that prescribers individualize dosing and use the lowest dose of an ESA that is sufficient to reduce the need for transfusion. ...