Policy & Public Affairs
Press Release
TO: ASN Members
FROM: William Henrich, M.D.
DATE: March 28, 2007
RE: FDA Black Box (Public Health) Warning on Erythropoiesis-Stimulating Agents (ESAs)
The Food and Drug Administration (FDA) issued a public health advisory outlining new safety information, including a revised product labeling about erythropoiesis-stimulating agents (ESAs) widely used for treatment of anemia. The drugs affected by the advisory are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). Amgen and Ortho Biotech LP have agreed with the FDA to modify the product label that includes updated warnings, a new-boxed warning and modifications to the dosing instructions.
In response to the FDA warning, Center for Medicare & Medicaid Services (CMS) issued a press release on March 14, 2007 , announcing that it is reviewing all Medicare policies relating to the administration of ESAs. As you are aware, in 2006, CMS implemented a revised Epogen Monitoring Policy for in-center hemodialysis patients which established a mandatory 25 percent reduction in the EPO dose if a patient's hemoglobin exceeds 13 or a payment reduction equal to the amount payable had the 25 percent dose reduction occurred. The CMS announcement specifically states that CMS "is currently reviewing its Erythropoietin (EPO) monitoring policy for patients with ESRD, and who are dialyzed in renal facilities".
The FDA's warning was prompted by a recently completed clinical trial that described increased risks in patients with chronic kidney disease when ESAs were given to target higher than currently recommended hemoglobin concentrations, and additional trials in cancer patients. The FDA notes “the agency (FDA) is in the process of re-evaluating of the safety of Aranesp, Epogen and Procrit on the basis of the results of recent clinical studies.” The basis for the warning was several trials in multiple conditions with different outcome measures.
Since their introduction in 1989, ESA's have dramatically improved the quality of life of patients and fundamentally changed care for dialysis patients. The use of ESAs in dialysis patients has greatly lowered the blood transfusion rate, thereby preventing all sensitization and allowing more patients to receive a kidney transplant. The ASN understands that nephrologists and patients may have questions and concerns about starting or continuing use of Epogen (or other ESAs) after they hear or read about the FDA public health warning. We firmly believe that medical treatment decisions relating to a patient's care should remain with the treating physician and be based on scientific evidence, sound clinical judgment and communication with patients and their family members.
Below, please find links to the aforementioned FDA and CMS press releases and related information. The ASN will continue to monitor developments at the FDA and CMS and issue updates to its membership as soon as new information becomes available.
FDA Warning Press Release
CMS Press Release
FDA Press Release on EPO Safety Information
Additional information on Erythropoiesis Stimulating Agents: