Erythropoiesis Stimulating Agents

Erythropoiesis is the process by which red blood cells are developed within the red bone marrow. In some instances this bodily process does not function properly. Illnesses such as cancer, kidney disease and HIV can cause anemia, a disorder which causes erythropoiesis to slow down, thereby decreasing the number of red blood cells that are produced. Some of the symptoms of anemia include loss of energy, pale skin, shortness of breath and fatigue.

Certain medications, known as erythropoiesis stimulating agents, can assist in counteracting the effects of anemia by stimulating the production of red blood cells in the body. Erythropoiesis stimulating agents, also known as ESAs, are essentially an artificial version of the protein produced by the kidney (known as erythropoietin), which is responsible for the process of erythropoiesis. People with anemia have a reduced level of this protein. When taken properly, ESAs elevate the level of red blood cells in the body, thereby reducing the need for blood transfusions.

ESAs have been approved by the FDA and have been used by doctors for almost two decades. Physicians consider certain risks before deciding whether to use the drugs. Some studies have shown that the use of erythropoiesis stimulating agents can decrease the overall survival level of people with certain forms of cancer, as well as create higher incidence of thromboembolic events. These increased risks are seen in patients who are taking doses of ESAs in an effort to maintain target hemoglobin levels of 12 g/dL or higher. Because of this, the FDA has mandated that a "Black Box" warning be included on all ESA safety labels, disclosing the risks associated and advising that only the lowest dose necessary be administered for the reduction of blood transfusions.

Currently there are two FDA approved brands of ESAs, both manufactured by the pharmaceutical company Amgen. The first one, Epoetin alfa, is marketed under two different labels; Procrit® and Epogen®. Although identical in makeup, they are distributed by two different manufacturers. Epoetin alfa has been approved by the FDA for use since 1989. The second approved brand is Darbepoetin alfa, marketed under the label Aranesp®, which was approved by the FDA in 2001. In addition, there are two other brands, Eprex® / Erypo® and Neo- Recormon®, which are currently not approved for use in the United States.

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