Drugs
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Information on Erythropoiesis-Stimulating Agents (ESA) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
Erythropoiesis-Stimulating Agents (ESAs) are approved for the treatment of anemia (low red blood cells) resulting from chronic kidney failure, chemotherapy, certain treatments for Human Immunodeficiency Virus (HIV), and also to reduce the number of blood transfusions during and after certain major surgeries. ESAs work by stimulating the bone marrow to produce red blood cells.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
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Related Information
FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease
6/24/2011FDA Drug Safety Podcast for Healthcare Professionals: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease
6/27/2011- Enforcement Discretion Letter Regarding Aranesp Medication Guide (PDF - 33KB)
6/2/2011 - Enforcement Discretion Letter Regarding Epogen/Procrit Medication Guide (PDF - 33KB)
6/2/2011 - Aranesp Risk Evaluation and Mitigation Strategy (REMS) (PDF - 10.4MB)
- Epogen/Procrit Risk Evaluation and Mitigation Strategy (REMS) (PDF - 10.5MB)
FDA Announces New Safety Plan for Agents Used to Treat Chemotherapy-Related Anemia
2/16/2010FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp
2/16/2010Historical Information on Erythropoiesis Stimulating Agents (ESA) (marketed as Procrit, Epogen, and Aranesp) Questions and Answers on Medication Guides for Erythropoiesis-Stimulating Agents (ESAs) - 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) 10/1/2008
Early Communication about an Ongoing Safety Review of Epoetin Alfa
9/26/2008
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Labeling and Regulatory History from Drugs@FDA
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