FDA Strengthens ESA Safety Information

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The FDA issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs).

The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). FDA and the manufacturers of these products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions.

The new boxed warning advises physicians to monitor hemoglobin and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Physicians and patients should carefully weigh the risks of ESAs against transfusion risks.

Recently, studies describe an increased risk of death, blood clots, strokes, and MI in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery.

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