FDA notified healthcare professionals 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 FDA released the statement above after the New England Journal of Medicine published results of a research study about Procrit, an erythropoiesis-stimulating agent (ESA) also known as recombinant human erythropoietin. The study found a higher chance of the combination of death, heart attack, hospitalizations for heart failure and stroke in patients with chronic kidney disease who are not on dialysis and were treated with Procrit to raise their hemoglobin levels higher than what the labeling for the product recommends. Procrit, like the other ESAs Epogen, and Aranesp, increases blood hemoglobin levels, the oxygen carrying component of blood, by increasing the number of red blood cells in the body. These products are used to treat anemia in certain patients.
Click here for more information