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FDA Changes Erythropoiesis-Stimulating Agent Dosing

Agency provides new recommendations due to increased risk of cardiovascular events

FRIDAY, June 24 (HealthDay News) -- The U.S. Food and Drug Administration has recommended more conservative dosing guidelines for the use of erythropoiesis-stimulating agents (ESAs) in the treatment of anemia associated with chronic kidney disease, as these drugs are tied to an increased risk of cardiovascular events.

ESAs are synthetic versions of the human protein erythropoietin, which stimulates red blood cell production in bone marrow. The drugs are indicated for the treatment of various forms of anemia associated with chronic kidney disease, chemotherapy, and other conditions. Drugs that belong to the ESA class include epoetin alfa (Epogen and Procrit) and darbepoetin alfa (Aranesp).

The FDA is currently recommending more conservative dosing guidelines and adding modified recommendations to the Boxed Warning and other sections of the package insert based on clinical trials data that revealed an increased risk of cardiovascular events, including heart attack and stroke, when dosed to achieve a normal or nearly normal blood hemoglobin level. In addition, these drugs have not been shown to improve quality of life, fatigue, or patient well-being. The new ESA package labeling will no longer have a recommended target range (10 to 12 grams/deciliter) at which to achieve and maintain hemoglobin levels and will recommend individualized dosing and use of the lowest possible dose of ESA sufficient to reduce the need for transfusion.

"Health care practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risks," John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement. "The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions."

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