Press Announcements > FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents

The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.


ESAs are synthetic versions of a human protein known as erythropoietin, which stimulates primitive cells in the bone marrow to produce red blood cells, the main oxygen-carrying cells in the blood. Blood hemoglobin is a laboratory measure of the number of red blood cells in the blood. Anemia is an abnormally low hemoglobin value.

ESAs are approved to treat some forms of anemia resulting from CKD, chemotherapy and certain other conditions. Drugs in the ESA class are epoetin alfa, marketed as Epogen and Procrit, and darbepoetin alfa, marketed as Aranesp.

The modified recommendations are being added to the Boxed Warning and other sections of the package insert in response to clinical trials showing an increased risk of cardiovascular events, such as heart attack and stroke, when ESAs are dosed to achieve a normal or nearly normal blood hemoglobin level. In addition, ESAs have not been shown to improve quality of life, fatigue, or patient well-being.

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Press Announcements > FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents