Abstract
BackgroundIn March, 2007, a black box warning was issued by the Food and Drug Administration (FDA) to use the lowest possible erythropoiesis-stimulating agents (ESA) doses for treatment of anemia associated with renal disease. The goal is to determine if a change in ESA use was observed following the warning among US dialysis patients.MethodsESA therapy was examined from September 2004 through August 2009 (thirty months before and after the FDA black box warning) among adult Medicare hemodialysis patients. An interrupted time series model assessed the impact of the warnings.ResultsThe FDA black box warning did not appear to influence ESA prescribing among the overall dialysis population. However, significant declines in ESA therapy after the FDA warnings were observed for selected populations. Patients with a hematocrit ≥36% had a declining month-to-month trend before (−164 units/week, p = <0.0001) and after the warnings (−80 units/week, p = .001), and a large drop in ESA level immediately after the black box (−4,744 units/week, p = <.0001). Not-for-profit facilities had a declining month-to-month trend before the warnings (−90 units/week, p = .009) and a large drop in ESA dose immediately afterwards (−2,487 units/week, p = 0.015). In contrast, for-profit facilities did not have a significant change in ESA prescribing.ConclusionsESA therapy had been both profitable for providers and controversial regarding benefits for nearly two decades. The extent to which a FDA black box warning highlighting important safety concerns influenced use of ESA therapy among nephrologists and dialysis providers was unknown. Our study found no evidence of changes in ESA prescribing for the overall dialysis population resulting from a FDA black box warning.
Highlights
In March, 2007, a black box warning was issued by the Food and Drug Administration (FDA) to use the lowest possible erythropoiesis-stimulating agents (ESA) doses for treatment of anemia associated with renal disease
In 1987, investigators reported successful use of erythropoietin stimulating agents (ESA known as rHuEPO, epoetin or EPO, trade name EPOGEN®) in treating the anemia by elevating the hematocrit level of end-stage renal disease (ESRD) patients and reducing transfusions
United States Renal Data System (USRDS) data system is a national resource that includes demographic and clinical data on ~97% of all US ESRD patients and their institutional providers of dialysis treatment. (The USRDS website, http://www. usrds.org, “Researcher’s Guide to the USRDS Database” describes the variables, data source, collection methods, and validation studies.) The hematocrit reading taken prior to the first administration of ESA therapy during the billing period was submitted for payment with the total dose of ESA administered over the exposure period
Summary
In March, 2007, a black box warning was issued by the Food and Drug Administration (FDA) to use the lowest possible erythropoiesis-stimulating agents (ESA) doses for treatment of anemia associated with renal disease. The goal is to determine if a change in ESA use was observed following the warning among US dialysis patients. In 1987, investigators reported successful use of erythropoietin stimulating agents (ESA known as rHuEPO, epoetin or EPO, trade name EPOGEN®) in treating the anemia by elevating the hematocrit level of ESRD patients and reducing transfusions. On March 9, 2007, FDA issued a black box public health warning to physicians to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. According to the FDA, “physicians and patients should carefully weigh the risks of ESAs against transfusion risks.” The goal of this study was to examine if providers changed their prescribing of ESA therapy as a result of the FDA warnings
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