Navigation Links
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.


'/>"/>
SOURCE National Patient Advocate Foundation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. International study strengthens case for daily calcium pill
2. Yakima Health Care Leader Tapped for Leadership Post at National Association
3. Virginia Tech Report Has National Importance
4. Donate Life America Dispels Myths About Organ & Tissue Donation Among Hispanics During National Hispanic Heritage Month
5. Us TOO Launches National SEA Blue Campaign for Prostate Cancer Awareness Month
6. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
7. National Association of Subrogation Professionals (NASP), the Largest Insurance Subrogation Association in the World - Announced Today that Leslie Wiernik has Joined the Organization as Director of Education
8. 4-Star Gen. Barry McCaffrey, Former U.S. Drug Czar, to Address National Drug Crisis, Keynote Grand Opening of New Allenwood, PA National Model Detox Center
9. Australian-led international study shows blood pressure drugs cut death rate in type 2 diabetes
10. LCA Hails International Investigators Studying Lung Cancer
11. National Patient Safety Foundation Partners with Vocera Communications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... ... February 12, 2016 , ... ... initiative—the Siemens Foundation-PATH Ingenuity Fellowships—to develop the advanced skills needed to introduce ... from U.S. universities who will draw from Siemens’ deep knowledge of product ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... ... 29, 2016 — 1:30 p.m. – 3:00 p.m. EST, http://www.fdanews.com/fixeddosecombination ... the life cycle of pharmaceutical products, garnering increased attention from all stakeholders in ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... Coco Libre, ... participation in Red Carpet Events LA GRAMMY’s Style Lounge Event. Coco Libre will offer ... to stay hydrated before the big event. The invitation-only gifting suite, held this year ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... (WaaS), today announced the integration of Clarity Intelligence Platform (CIP) into Cielo®, a ... offer real-time business intelligence (BI) to their small and medium business (SMB) clients. ...
(Date:2/12/2016)... ... ... AssureVest Insurance Group, a locally owned insurance firm with offices serving Washington ... earmarked to purchase computers and software for Mrs. Harrison’s 2nd and 3rd grade special ... low-income area and has more than 60 2nd and 3rd graders with learning disabilities. ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... 12 februari 2016 AAIPharma Services ... leverancier van productie en ontwikkeling op maat ... vandaag een uitbreiding aan van steriele vul- ... in Charleston, SC . ... meerdere recente investeringen. http://photos.prnewswire.com/prnh/20150806/256637LOGO ...
(Date:2/12/2016)... BUDAPEST , Ungarn, February 12, 2016 ... ein Medizintechnikunternehmen, das sich auf den ungedeckten ... gab heute positive Ergebnisse seines klinischen Forschungsprogramms ... und Asthma-Patienten beschäftigt, ergab Verbesserungen ihrer respiratorischen ... Indiso ltd , ein Medizintechnikunternehmen, das ...
(Date:2/11/2016)... - Cardiac Marker Diagnostic ... and Cancer Therapy. - European Point of Care ... - Key Diagnostic Testing Markets. - Molecular ... Genetic Testing. - Molecular Diagnostics in Infectious Disease ... Diagnostic Products World Markets. - Point of Care ...
Breaking Medicine Technology: