The FDA has notified healthcare professionals nationwide of a newly published clinical study showing that patients treated with an erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL are at a significantly increased risk for serious and life threatening cardiovascular complications, as compared to use of the ESA to target a hemoglobin concentration of 11.3 g/dL.

The "Correction of Hemoglobin and Outcomes in Renal Insufficiency" study, published Nov. 16, 2006 in the New England Journal of Medicine, reports the adverse cardiovascular complications as a composite of the occurrence of one of the following events: death, myocardial infarction, hospitalization for congestive heart failure or stroke.

The study findings underscore the importance of following the currently approved prescribing information for Procrit, Epogen and Aranesp, including the dosing recommendation that the target hemoglobin not exceed 12 g/dL.