Pure Red-Cell Aplasia and Epoetin Therapy

In 2002, the Journal published a report of 13 cases of pure red-cell aplasia in patients with renal failure who were receiving erythropoietin (epoetin). From 1998 through 2003, 175 cases were associated with the use of Eprex (epoetin alfa), 11 with the use of Neorecormon (epoetin beta), and 5 with the use of Epogen (epoetin alfa). After the promulgation of new regulatory mandates, the incidence of pure red-cell aplasia associated with epoetin therapy was reduced by more than 80 percent. From 1998 through 2003, 175 cases were associated with the use of Eprex (epoetin alfa). After new regulatory mandates, the incidence of red-cell aplasia was reduced by more than 80 percent. Antibody-mediated pure red-cell aplasia is a rare syndrome of anemia associated with a low reticulocyte count, an absence of erythroblasts in the bone marrow, resistance to recombinant human erythropoietin (epoetin) therapy, and neutralizing antibodies against erythropoietin. 1 Between 1988 and 1998, this syndrome was reported in three patients who had been treated with epoetin. 2 – 4 By contrast, between 1998 and 2000, 13 patients with chronic kidney disease in France were found to have pure red-cell aplasia with neutralizing antierythropoietin antibodies after receiving epoetin administered subcutaneously 1 ; 12 patients had received the Eprex formulation of epoetin alfa and 1 Neorecormon (a formulation . . .