Advisory Issued on Erythropoietin and CKD Patients

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In response to a study published in the New England Journal of Medicine (2006;355: 2085-2098) and covered extensively in the lay media, the FDA has issued a public health advisory on the use of erythropoiesis-stimulating agents (ESAs), also known as recombinant human erythropoietin, for treating patients with CKD anemia.

 

The Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study evaluated the potential benefit and harm from treatment with epoetin alfa (Procrit) in CKD patients who are not on dialysis (see article on page 19).

 

The unexpected results showed that patients who were treated with Procrit to raise their blood hemoglobin concentration higher than the maximum recommended level of 12 g/dL (listed on all ESA labeling) experienced higher rates of death, MI, and hospitalizations for heart failure and stroke. Procrit, like the other ESAs (Epogen and Aranesp), raises hemoglobin levels by increasing the number of red blood cells, and is used to treat anemia.

 

FDA advises that hemoglobin levels be maintained at 10-12 g/dL and that frequent tests to monitor hemoglobin are an essential part of an ongoing ESA treatment plan.

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