Use of parenteral iron products and serious anaphylactic-type reactions

American Journal of Hematology

Volumn 85, Issue 9, 2010, Pages 650-654

  Wysowski, Diane K ^a   Swartz, Lynette ^a   Borders Hemphill, B Vicky ^a   Goulding, Margie R ^a   Dormitzer, Catherine ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANEMIC AGENT; FERRIC ION;

ANAPHYLAXIS; CHEMICALLY INDUCED; DRUG HYPERSENSITIVITY; EPIDEMIOLOGY; FOOD AND DRUG ADMINISTRATION; HUMAN; MORTALITY; RETROSPECTIVE STUDY; RISK FACTOR; UNITED STATES;

ANAPHYLAXIS; DRUG HYPERSENSITIVITY; FERRIC COMPOUNDS; HEMATINICS; HUMANS; RETROSPECTIVE STUDIES; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77956481295     PISSN: 03618609     EISSN: 10968652     Source Type: Journal    
DOI: 10.1002/ajh.21794     Document Type: Article

References (31)

1. Danielson BG. Structure, chemistry, and pharmacokinetics of intravenous iron agents. J Am Soc Nephrol 2004;15:S93-S98.
2. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. On the relative safety of parenteral iron formulations. Nephrol Dial Transplant 2004;19:1571-1575.
3. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant 2006;21:378-382.
4. Rodgers GM, Auerbach M, Cella D, et al. High-molecular weight iron dextran: A wolf in sheep's clothing? J Am Soc Nephrol 2008;19:833-834.
5. IMS Health, National Sales Perspective.™ Combined data from retail and non-retail, 2002-2007. IMS Health, Plymouth Meeting, Pa. Data extracted 3/29/07 and 7/7/08.
6. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002. Arch Intern Med 2005;165:1363-1369.
7. Public use data tape documentation. Multiple cause of death for ICD-9 and ICD-10 data. Hyattsville, MD: U.S. Department of Health and Human Services, Public Health Service, National Center for Health Statistics.
8. Manual of the International Statistical Classification of Diseases, Injuries, and Causes of Death, 9th revision. Geneva, Switzerland: World Health Organization, 1977.
9. International Statistical Classification of Diseases and Related Health Problems, 10th revision. Geneva, Switzerland:World Health Organization, 1992.
10. Wysowski DK, Nourjah P. Analyzing prescription drugs as causes of death on death certificates (letter). Public Health Rep 2004;119:520.
11. Jhung MA, Budnitz DS, Mendelsohn AB, et al. Evaluation and overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES). Med Care 2007;45:S96-S102.
12. Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Drug Abuse Warning Network, 2003: Interim National Estimates of Drug-Related Emergency Department Visits. DAWN Series D-26. DHHS Publication No. (SMA) 04-3972. Rockville, MD, 2004.
13. Facts and Comparisons Online 2010 by Wolters Kluwer Health, Inc. Accessed 3-11-10.
14. McCarthy JT, Regnier CE, Loebertmann CL. Adverse events in chronic hemodialysis patients receiving intravenous iron dextran - A comparison of two products. Am J Nephrol 2000;20:456-462.
15. Fletes R, Lazarus JM, Gage J, Chertow GM. Suspected iron dextran-related adverse drug events in hemodialysis patients. Am J Kidney Dis 2001;37:743-749.
16. Walters BAJ, Van Wyck DB. Benchmarking iron dextran sensitivity: Reactions requiring resuscitative medication in incident and prevalent patients. Nephrol Dial Transplant 2005;20:1438-1442.
17. Fishbane S, Ungureanu V-D, Maesaka JK, et al. The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis 1996;28:529-534. (Pubitemid 26337591)
18. Laman CA, Silverstein SB, Rodgers GM. Parenteral iron therapy: A single institution's experience over a 5-year period. J Natl Comprehensive Cancer Network 2005;3:791-795.
19. Coyne DW, Adkinson NF Jr, Nissenson AR, et al. Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Kidney Int 2003;63:217-224.
20. Ganguli A, Kohli HS, Jha V, et al. The comparative safety of various intravenous iron preparations. Renal Failure 2008;30:629-638.
21. Faich G, Strobos J. Sodium ferric gluconate complex in sucrose: Safer intravenous iron therapy than iron dextran. Am J Kidney Dis 1999;33:464-470.
22. Bailie GR, Clark JA, Lane CE, Lane PL. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant 2005;20:1443-1449.
23. Michael B, Coyne DW, Fishbane S, et al. Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Kidney Int 2002;61:1830-1839.
24. Michael B. The safety of sodium ferric gluconate complex in haemodialysis patients has been extensively evaluated. Nephrol Dial Transplant 2005;20:1770.
25. Kosch M, Bahner U, Bettger H, et al. A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer) vs. iron gluconate (Ferrlecit) in hemodialysis patients treated with rHuEpo. Nephrol Dial Transplant 2001;16:1239-1244.
26. Charytan C, Levin N, Al-Saloum M, et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis 2001;37:300-307.
27. Nissenson AR, Lindsay RM, Swan S, et al. Sodium ferric gluconate complex in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis 1999;33:471-482.
28. Silverstein SB, Rodgers GM. Parenteral iron therapy options. Am J Hematol 2004;76:74-78.
29. Mamula P, Piccoli DA, Peck SN, et al. Total dose intravenous infusion of iron dextran for iron-deficiency anemia in children with inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2002;34:286-290.
30. Auerbach M, Pappadakis J, Bahrain H, et al. Rapid (sixty minutes) infusion of one gram of low molecular iron dextran: Safety and efficacy profile. Blood (ASH annual meeting Abstracts) 2009;114:abstract 4054.
31. Bishu K, Agarwal R. Acute injury with intravenous iron and concerns regarding long-term safety. Clin J Am Soc Nephrol 2006;1:S19-S23.