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

Communication about an Ongoing Safety Review [1/3/2008]: This communication provides you with the findings from two additional clinical studies (PREPARE and GOG-191 studies) showing an increase in mortality and shorter time to tumor progression in patients with cancer receiving an ESA. More information

FDA Alert [11/8/2007]: FDA is issuing this alert to update healthcare professionals about revisions to the product labeling for the erythropoiesis-stimulating agents (ESAs) [Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)]. These revisions are intended to clarify the evidence for safety and effectiveness and provide more explicit directions and recommendations to prescribers on their use. More information

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Healthcare Professional Information

• Communication about an Ongoing Safety Review (1/3/2008)
• Information for Healthcare Professionals
• Prescribing Information
  • Epogen Labeling
    • Patient Information from Labeling
  • Procrit Labeling
    • Patient Information from Labeling
  • Aranesp Labeling
    • Patient Information from Labeling

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)
• Approval History for Epogen and Procrit from Drugs@FDA
• Approval History for Aranesp from Drugs@FDA

Historical Information

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Date created: November 16, 2006, updated January 3, 2008

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