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:9/21/2017)... ... September 21, 2017 , ... Preora Diagnostics Inc. ... screening tests, has received two prestigious recognitions that acknowledge the promise of its ... Preora has been named a Top 100 Finalist for the 16th annual ...
(Date:9/21/2017)... ... September 21, 2017 , ... FlipBelt, the fitness brand ... to detail to the athletic wear market with the launch of their FlipBelt Crops. ... have their essentials securely at their fingertips while at the gym, on the trail, ...
(Date:9/21/2017)... ... September 21, 2017 , ... ... Month, Lewis and Clark College Emeritus Professor of Education Gregory A. Smith examines ... of Asleep at the Switch: Schoolhouse Commercialism, Privacy, and the Failure of ...
(Date:9/20/2017)... ... September 20, 2017 , ... ... Coating System for clients that rely on safety and cleanliness. This unique flooring ... , Silver has been used for centuries for its antimicrobial properties. Unlike antibiotics, ...
(Date:9/20/2017)... ... ... Doctors on Liens has added the medical group Bones and Spine Surgery, ... personal injury lien basis. Founded by Dr. Wayne Cheng, MD and Dr. Gordon Yee, ... orthopedic injuries to patients in the Inland Empire. , Bones and Spines Surgery Inc ...
Breaking Medicine News(10 mins):
(Date:9/6/2017)... WILMINGTON, Del. , Sept. 6, 2017 NeuroRx, ... for Acute Suicidal Ideation and Behavior (ASIB), has been granted ... for its sequential therapy of NRX-100 (ketamine HCl) followed by ... patients in a pivotal trial of this sequential therapy targeting ... bipolar depression. 1 ...
(Date:9/5/2017)... Pa. , Sept. 5, 2017  Xyntek Inc. has announced another milestone ... a new Midwest office to meet the growing demands of customer engagements regionally.  ... Xyntek's new Midwest office is located at 318 ... ... of customer engagements regionally. ...
(Date:9/5/2017)... Sept. 5, 2017 Oramed Pharmaceuticals Inc. (NASDAQ: ... clinical-stage pharmaceutical company focused on the development of oral ... concluded its meeting with the U.S. Food and Drug ... formulation. At the ... pathway for submission of ORMD-0801, would be a Biologics ...
Breaking Medicine Technology: