Follow Up to the January 3, 2008 Communication About an Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp)

This information reflects FDA’s current analysis of available data concerning these drugs. FDA intends to update this document when additional information or analyses become available.

On April 22, 2008, FDA notified the manufacturer of Epogen/Procrit and Aranesp of its decision to require additional safety-related changes to the labeling for these products.

Amgen submitted labeling supplements for Epogen/Procrit and Aranesp on May 22, 2008, following the March 13, 2008 Oncologic Advisory Committee’s recommendations to make additional safety-related changes to the labeling for these products. Amgen and FDA have agreed on many of these changes, including to replace the existing Patient Package Insert with a Medication Guide and to modify certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of package insert.

These changes are intended to clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should not be initiated. While agreement was reached on the general concepts, Amgen and FDA have not reached agreement on specific wording on two points, including a warning statement that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and statements regarding when to initiate and to discontinue ESA dosing. Labeling discussions concluded on July 15 and FDA issued a letter ordering the additional changes on July 30, 2008.

FDA’s action to require these safety labeling changes follows the completion of the review of information received in November 2007 and December 2007 and are in keeping with the recommendations made at the March 13, 2008 Oncologic Drugs Advisory Committee meeting. Amgen has been ordered to make the additional changes under new authorities provided in the FDA Amendments Act of 2007 and has 5 days to appeal or 15 days to submit a supplement containing the labeling changes.

FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Epogen, Procrit and Aranesp to the FDA MedWatch reporting program, as described below.

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

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)
• Approval History for Aranesp from Drugs@FDA

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
• Approval History for Epogen and Procrit from Drugs@FDA

Historical Information

Report Adverse Events to MedWatch  

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Date created: November 16, 2006, updated August 1, 2008

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