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
  

 

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.