Skip to content
America's Blood Centers
  • About
    • Team
    • Board of Directors
    • Committees
    • ABC Strategic Plan
    • ADRP
    • Partners
    • Foundation
  • Advocacy
    • Value Framework
    • 2021 Advocacy Agenda
    • Comments & Letters
    • Resources
  • Events
    • Sponsors
      • Sponsorship Opportunities
    • Awards
  • News
    • January is National Blood Donor Month
    • ABC Publications
    • ABC Coronavirus Resources
  • Membership
    • Join Us
    • Member Resources
    • Membership Directory
    • Get Involved
    • Careers
  • For Donors
    • Convalescent Plasma Donation
    • Blood Donation FAQs
    • Blood Donation 101
    • Blood Donation Types and Collection Procedures
    • Journey of Blood
    • America’s Blood Supply
    • Find a Blood Center
    • Why Donate
  • Contact
FacebookTwitterYoutubeFlickr
  • Member Login
America's Blood Centers
  • About
    • Team
    • Board of Directors
    • Committees
    • ABC Strategic Plan
    • ADRP
    • Partners
    • Foundation
  • Advocacy
    • Value Framework
    • 2021 Advocacy Agenda
    • Comments & Letters
    • Resources
  • Events
    • Sponsors
      • Sponsorship Opportunities
    • Awards
  • News
    • January is National Blood Donor Month
    • ABC Publications
    • ABC Coronavirus Resources
  • Membership
    • Join Us
    • Member Resources
    • Membership Directory
    • Get Involved
    • Careers
  • For Donors
    • Convalescent Plasma Donation
    • Blood Donation FAQs
    • Blood Donation 101
    • Blood Donation Types and Collection Procedures
    • Journey of Blood
    • America’s Blood Supply
    • Find a Blood Center
    • Why Donate
  • Contact
February 6, 2018

Joint Comments on Request for Removal of Hydroxyethyl Starch from the U.S. Market

By America's Blood Centers

The complaint from Public Citizen referenced in this docket requests removal of hydroxyethyl starch (HES) from the U.S. market. America’s Blood Centers, the American Red Cross, AABB and the American Society for Apheresis oppose this. These solutions met the extant regulatory requirements for approval when originally submitted, but the extensive literature on their lack of efficacy for resuscitation indications, and their association with adverse clinical outcomes resulted in “black box” warnings in the prescribing information. This makes the agency’s continuing review of their use in those indications appropriate. However, the broad case made for removal of the product from the market ignores, and in fact does not even recognize, other uses for HES, where available data do not suggest problems like those seen associated with resuscitation (see accompanying references).

Read the Statement
Posted in Statements
Share this

Recent Posts

  • Joint Statement on the Widespread Snow and Ice Disrupting Nation’s Blood Supply
  • Joint Comments Submitted – Most Favored Nation (MFN) Model (CMS-5528-IFC)
  • Blood Community Encourages Individuals to Donate Blood, Convalescent Plasma During National Blood Donor Month and Beyond
  • ADRP has been awarded a grant from Terumo Blood and Cell Technologies
  • Joint Letter to FDA Regarding COVID-19 Convalescent Plasma (CCP) Emergency Use Authorization (EUA) Implementation

Categories

  • Advocacy News
  • Letters
  • Letters and Comments
  • News
  • Press Releases
  • Statements

Subscribe for Updates

Sign up to receive updates from America’s Blood Centers.

* indicates required

America's Blood Centers
1717 K Street NW, Suite 900
Washington, DC 20006

Tel: 202-393-5725

Fax: 202-899-2621

  • About
    • Team
    • Board of Directors
    • Committees
    • ABC Strategic Plan
    • ADRP
    • Partners
    • Foundation
  • Advocacy
    • Value Framework
    • 2021 Advocacy Agenda
    • Comments & Letters
    • Resources
  • Events
    • Sponsors
      • Sponsorship Opportunities
    • Awards
  • News
    • January is National Blood Donor Month
    • ABC Publications
    • ABC Coronavirus Resources
  • Membership
    • Join Us
    • Member Resources
    • Membership Directory
    • Get Involved
    • Careers
  • For Donors
    • Convalescent Plasma Donation
    • Blood Donation FAQs
    • Blood Donation 101
    • Blood Donation Types and Collection Procedures
    • Journey of Blood
    • America’s Blood Supply
    • Find a Blood Center
    • Why Donate
  • Contact
  • Sitemap
  • Privacy Policy
  • Terms of Use
Become a Member
Member Login

Copyright © 2021 © America’s Blood Centers. All Rights Reserved.

Website by Yoko Co

Scroll To Top