Erythropoietic-Stimulating Agents (ESAs): New Safety Warning

References 

1. Information on erythropoeisis-stimulating agents (marketed as Aranesp, Epogen and Procrit). Food and Drug Administration, Department of Health and Human Services. Created November 16, 2006 and updated March 9, 2007. Available at: www.fda.gov/cder/drug/infopage/RHE/default.htm. Accessed April 16, 2007.
2. Danish Head and Neck Cancer Group (DAHANCA). DAHANCA 10 Trial Interim analysis and study termination. Available at: http://conman,au.dk/dahanca/. Accessed April 16, 2007.
3. Oncology Drugs Advisory Committee of the Food and Drug Administration. ESA Safety Briefing Information. 2004;May 4, Available at: www.fda.gov/ohrms/dockets/ac/04/briefing/4037b2.htm. Accessed April 16, 2007
4. Erythropoiesis stimulating agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa). 2007;January 27, Available at: www.fda.gov/medwatch/safety/2007/safety07.htm#ESA. Accessed April 16, 2007
5. Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355:2085–2098
   • CrossRef
6. Drüeke TB, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006;355:2071–2084
   • CrossRef
7. Aranesp^© (darbepoetin alfa) product information. Thousand Oaks, CA: Amgen Manufacturing; 2007;March, Available at: www.aranesp.com/professional/ckd/pi/pi.jsp#boxed_warnings. Accessed April 16, 2007
8. Procrit^© (epoetin alfa) product information. Raritan, NJ: Ortho Biotech Products; 2007;March, Available at: www.orthobiotech.com/common/prescribing_information/PROCRIT/PDF/ProcritBooklet.pdf. Accessed April 16, 2007
9. Dharmarajan TS, Pais W, Norkus EP. Does anemia matter? (Anemia, morbidity, and mortality in older adults: need for greater recognition). Geriatrics. 2005;60:22–27
   • MEDLINE
10. Nissenson AR, Goodnough LT, Dubois RW. Anemia: not just an innocent bystander?. Arch Intern Med. 2003;163:1400–1404
    • MEDLINE
    • CrossRef
11. Uralic JM, Eisenstaedt RS, Ferrucci L, et al. Prevalence of anemia in persons 65 years of age or older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004;104:2263–2268
    • MEDLINE
    • CrossRef
12. Spivak JL. Anemia in the elderly: time for new blood in old vessels?. Arch Intern Med. 2005;165:2187–2189
    • MEDLINE
    • CrossRef
13. Tsakiris D. Morbidity and mortality reduction associated with the use of erythropoietin. Nephron. 2000;85(suppl 1):2–8
    • CrossRef
14. Procrit^© (epoetin alfa) product information. Raritan, NJ: Ortho Biotech Products; 2005;November
15. National Kidney Foundation. K/DOQI Clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease, National Kidney Foundation. 2006;May, Available at: www.kidney.org/professionals/KDOQI/guidelines_anemia/cpr21.htm. Accessed April 16, 2007
16. US Food and Drug Administration, Department of Health and Human Services. FDA Public Health Advisory, Epoetin alfa (marketed as Epogen, Procrit) and Darbepoetin alfa (marketed as Aranesp). 2006;November 16, Available at: www.fda.gov/cder/drug/advisory/RHE.htm. Accessed April 16, 2007
17. CMS Manual System. State Operations Manual: Appendix P. Survey Protocol for Long Term Care Facilities—Part I. Department of Health and Human Services, Centers for Medicare & Medicaid Services. Available at: www.cms.hhs.gov/transmittals/downloads/R22SOMA.pdf. Accessed April 16, 2007.
18. McHenry MC, McSpadden CS. Changes in the State Operations Manual: implications for consultant pharmacy practice. Consult Pharm. 2006;21:948–961
    • MEDLINE