Tampa, Fla., May 2, 2007 - On April 26, 2007, the American Association of Kidney Patients (AAKP) joined with the Renal Physicians Association (RPA), the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) to express concerns regarding the recent Food and Drug Administration’s (FDA) black box warning on erythropoiesis stimulating agents (ESAs). The FDA warning cited several popular drugs used to treat anemia, and their ability/likelihood to increase the risk of death and other serious health problems in patients with kidney disease. AAKP strongly believes the management of anemia should be determined by the patient’s needs and the decision-making shared with the physician.
Brenda Dyson, Immediate Past President of AAKP and a kidney patient, provided the only patient perspective to the FDA representing AAKP’s stand concerning the use of ESAs. Ms. Dyson told her personal story describing her life on dialysis before the use of ESAs, and working full time with a hemoglobin level of seven or eight. She articulated that patients have already begun to refuse ESAs, especially those individuals who began dialysis after the arrival of such drugs; patients who have no reference of the severe anemia associated with chronic kidney disease (CKD).
“AAKP is very concerned about the safety and efficiency of ESAs, and applauds the FDA for reviewing this matter. Decisions with respect to appropriate target hemoglobin levels and ESA dosing should be individualized for each patient based on discussions with their physicians,” stated Ms. Dyson.
For more information on AAKP’s comments regarding ESA use, contact AAKP at (800) 749-AAKP.
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