How safe are erythropoiesis-stimulating agents?

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Will the FDA take ESAs off the market? That is unlikely. Nephrologists need these drugs to avoid the need for transfusion in dialysis patients (see the accompanying article by Drs. Demirjian and Nurko on the use of ESAs in patients with chronic kidney disease on page 353 of this issue of the Journal). Some of the very first signals of harm with raising the hemoglobin too high came from the nephrology field.

Hematologists should still have the option of using ESAs in some settings, particularly in patients with low-risk myelodysplasia who are becoming more and more anemic and in those who have comorbid conditions in which lower hemoglobin levels are unsafe, particularly if they have coronary artery disease. They also should still be able to use ESAs for selected patients who develop severe chemotherapy-induced anemia and who become so weakened from their anemic state that their life and quality of life are threatened. If ESAs are taken away from the formulary of hematologists and oncologists, these specialists will rely on transfusions to treat their anemic patients, whether the anemia be due to myelodysplasia or to chemotherapy. Some say that the blood supply is so safe that we should not have the same worries about using blood transfusions as we did in the late 1980s. However, we all have seen patients who adamantly do not want transfusions.

Certainly, more events will transpire in the next year with the ESAs. There will probably be more data on erythropoietin receptors on the surface of tumor cells and what happens when pharmacologic doses of erythropoietin interact with these receptors. Patient-specific meta-analyses will probably shed more light on individual patients’ risk of thromboembolic disease and early death from the use of these agents.

The ESA story is far from over.

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