Historical Information on Erythropoiesis Stimulating Agents (ESA)
(marketed as Procrit, Epogen, and Aranesp)

Healthcare Professional Information

Follow Up to the January 3, 2008 Communication About an Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) (10/1/2008)

Aranesp Information

• Complete Response and Safety Labeling Change Order
  • Signed version
  • Unsigned version
• Package Insert (labeling)
• Medication Guide
• Patient Instructions
  • Single dose vial
  • Single-Dose Prefilled Syringe (SingleJect)

Epogen and Procrit Information

• Complete Response and Safety Labeling Change Order
  • Signed version
  • Unsigned version
• Package Insert (labeling)
  • Epogen
  • Procrit
• Medication Guide
  • Epogen
  • Procrit
• Patient Instructions
  • Epogen
  • Procrit

• Communication about an Ongoing Safety Review (1/3/2008)
• Information for Healthcare Professionals

Other Information

• Public Health Advisory (11/8/2007)
• Questions and Answer for Erythropoiesis-stimulating Agents (ESAs) Labeling Changes (11/8/2007)
• FDA News: FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs)

June 26, 2007

• Statement of John K. Jenkins, M.D., regarding erythropoiesis-stimulating agents (ESA) before the Committee on Ways and Means Subcommittee on Health, U.S. House of Representatives

March 9, 2007

• FDA News: FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs)
• Questions and Answers
• Information for Healthcare Professionals
• Public Health Advisory

November 16, 2006

• Information for Healthcare Professionals
• Public Health Advisory
  

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Date created: January 3, 2008, updated December 2, 2008

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