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National Patient Advocate Foundation (NPAF) Statement Regarding New FDA Label on Erythropoietin Stimulating Agents (ESAs)
Date:11/9/2007

ic proof based on the findings of six studies conducted in which ESA dosing levels were higher than the current label dosing indications. We commend that tough decision by FDA. Until better evidence on these treatments can be developed, we believe that patients and physicians are best served by adhering to the label restrictions FDA has now put in place on ESAs.

In the meantime, we encourage patients to visit http://www.npaf.org to view the FDA Public Health Announcement, FDA Questions and Answers and the full text of the new FDA labels for the Epogen and Aranesp and to contact our specialized case managers via 1-800-532-5274 to learn more.


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