Adverse event issue management: What have we learnt from pure red cell aplasia (PRCA)?

Abstract

After 1998, the number of reported cases of pure red cell aplasia (PRCA) increased dramatically among patients with chronic renal failure treated with exogenous erythropoietin, although the incidence of this condition has now abated. Antibody-positive PRCA has been most commonly associated with use of the Eprex® brand of epoetin-α. ESA (erythropoiesis-stimulating agent)-associated PRCA remains rare, and suspected cases should undergo a thorough diagnostic work-up before laboratory testing for anti-ESA antibody-positive status. This article provides an overview of the recent history and growing understanding of ESA-associated PRCA together with current approaches to the management of this rare side effect of an otherwise valuable therapy. © 2005 Oxford University Press.