Message to the FDA on ESAs: REMS Is Not Enough, More Studies Are Needed

[摘要] Since March 24, 2010, the Food and Drug Administration (FDA) has been requiring a “Risk Evaluation and Mitigation Strategy” (REMS) for all patients who are treated with erythropoiesis-stimulating agents (ESAs) (1). Although regulatory authorities elsewhere in the world have not as yet taken this approach, experience suggests that these agencies often take their cues from the FDA.

[学科分类] 泌尿医学

[关键词] Bone marrow necrosis;Sickle cell disease;Hyperhemolysis syndrome