FDA Recommend More Conservative Dosing of ESAs

The FDA is calling for more conservative dosing of erythropoiesis-stimulating agents (ESAs) when used to treat anemia in CKD patients due to the increased risks of cardiovascular events such as stroke, thrombosis, and death.

Clinical trials have demonstrated an increased risk of such events when ESAs are dosed to achieve a normal or nearly normal blood hemoglobin level (10 to 12 g/dL) in patients with CKD.

In addition, the drugs have not been shown to improve quality of life, fatigue, or patient well-being, according to the FDA.

The recommendations, which will be added to the boxed warning and other sections of the package inserts of epoetin alfa and darbepoetin alfa, now advise practitioners to individual ESA dosing for each patient and use the lowest dose of ESA sufficient to decrease the need for transfusion.

From the August 01, 2011 Issue of Renal and Urology News