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

WASHINGTON, Nov. 9 /PRNewswire-USNewswire/ -- The non-profit National Patient Advocate Foundation (NPAF), representing the voice of millions of patients assisted nationally in more than a decade through our direct-patient-services affiliate Patient Advocate Foundation (PAF), continues to routinely receive inquiries from patients wanting to know more about the use of Erythropoietin Stimulating Agents (ESA). These patients, with life-threatening, debilitating and chronic conditions, continue to seek information about best-available treatment and payment options from PAF - and we share their concerns and frustrations about the lack of information available on the safe use of ESAs.

We commend the FDA and ESA sponsors for their diligence, especially in recent months, to garner the information that patients and their physicians need to make the best informed decisions about the use of these important therapies.

NPAF believes that both the sponsors and the FDA have the responsibility to demonstrate to the American public that ESA drugs are safe and effective when administered within the recommended guidelines. Despite known and long-term safety concerns about these drugs, so far the evidence needed to clear up the questions of safety remains lacking. Further scientific studies are currently underway, but may take from months to years to complete. NPAF intends to promote the necessary clinical trials, and will participate in a workshop at the National Cancer Institute next month to further define the additional studies needed for ESA drugs.

Due to the urgent need for updated information reaching the public on ESAs, NPAF strongly encourages the FDA and sponsors to create a Medication Guide on ESAs, as discussed recently by Dr. Richard Padzur, director of the FDA Division of Oncology Drug Products.

In summary, FDA has taken the unusual position of raising serious concerns about ESA drugs despite what seems to be a lack of definitive scientific 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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SOURCE National Patient Advocate Foundation
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