Differences in the reporting rates of serious allergic adverse events from intravenous iron by country and population

Clinical Advances in Hematology and Oncology

Volumn 10, Issue 2, 2012, Pages 101-108

  Bailie, George R ^a   Verhoef, Jan Jaap ^b  

^a ALBANY COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

^b UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Allergic adverse events; Anaphylaxis; Intravenous iron; Iron dextran; Iron sucrose; Sodium ferric gluconate

Indexed keywords

FERRIC GLUCONATE; FERRIC HYDROXIDE SUCROSE; IRON DEXTRAN;

ALLERGIC REACTION; ANAPHYLAXIS; AUSTRIA; CONTROLLED STUDY; CZECH REPUBLIC; DRUG RESPONSE; GEOGRAPHIC DISTRIBUTION; HUMAN; IRELAND; ITALY; POLAND; POPULATION RESEARCH; PREVALENCE; REVIEW; SWITZERLAND; TURKEY (REPUBLIC); UNITED STATES;

ANAPHYLAXIS; DRUG HYPERSENSITIVITY; EUROPE; HUMANS; INFUSIONS, INTRAVENOUS; IRON COMPOUNDS; NORTH AMERICA;

EID: 84857083778     PISSN: 15430790     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (23)

1. Van Wyck DB, Roppolo M, Martinez CO, et al. A randomized controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysisdependent CKD. Kidney Int. 2005;68:2846-2856.
2. Bager P, Dahlerup JF. The health care cost of intravenous iron treatment in IBD patients depends on the economic evaluation perspective. J Crohns Colitis. 2010;4:427-430.
3. Krafft A, Breymann C. Iron sucrose with and without recombinant erythropoietin for the treatment of severe postpartum anemia: a prospective, randomized, open-label study. J Obstet Gynaecol Res. 2011;37:119-124.
4. Khalafallah A, Dennis A, Bates J, et al. A prospective, randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency of pregnancy. J Intern Med. 2010;268:286-295.
5. Van Wyck DB, Mangione A, Morrison J, et al. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009;49:2719-2728.
6. Nomura RM, Dias MC, Igai AM, et al. Anemia during pregnancy after silastic ring Roux-en-Y gastric bypass: influence of time to conception. Obes Surg. 2011;21:479-484.
7. Anker SD, Comin Colet J, Filippatos G, et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009;361:2436-2448.
8. Bastit A, Vandebroek A, Altintas S, et al. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alfa administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J Clin Oncol. 2008;26:1611-1618.
9. Dangsuwan P, Manchana T. Blood transfusion reduction with intravenous iron in gynecologic cancer patients receiving chemotherapy. Gynecol Oncol. 2010;116:522-525.
10. Pizzi LT, Bunz TJ, Coyne DW, et al. Ferric gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation. Kidney Int. 2008;74:1588-1595.
11. Mircescu G, Garneata L, Capusa C, Ursea N. Intravenous iron supplementation for the treatment of anaemia in pre-dialyzed chronic renal failure patients. Nephrol Dial Transplant. 2006;21:120-124.
12. Serrano-Trenas J, Uqalde P, Cabello LM, et al. Role of perioperative intravenous iron therapy in elderly hip fracture patients: a single-center randomized controlled trial. Transfusion. 2011;51:97-104.
13. Knight TG, Ryan K, Schaefer P, et al. Clinical and economic outcomes in Medicare beneficiaries with stage 3 or stage 4 chronic kidney disease and anemia: the role of intravenous iron therapy. J Manag Care Pharm. 2010;16:605-615.
14. Bailie GR, Clark JA, Lane CE, Lane PL. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant. 2005;20:1443-1449.
15. 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.
16. Wysowski DK, Swartz L, Borders-Hemphill BV, et al. Use of parenteral iron products and serious anaphylactic-type reactions. Am J Hematol. 2010;85:650-654.
17. Bailie GR, Horl WH, Verhoef JJ. Differences in spontaneously reported hypersensitivity and serious adverse events for intravenous iron preparations: comparison of Europe and North America. Arzneimittelforsch. 2011;61:267-275.
18. Toblli GE, Cao G, Oliveri L, Angerosa M. Differences between original intravenous iron sucrose and iron sucrose similar preparations. Arzneimittelforsch. 2009;59:176-190.
19. Toblli GE, Cao G, Oliveri L, Angerosa M. Differences between the original iron sucrose complex Venofer and the iron sucrose similar Generis and potential implications. Port J Nephrol Hypert. 2009;23:53-63.
20. Weber JCP. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. In: Rainslord KD, Velo EP, eds. Advances in Inflammation Research. New York, NY: Raven Press; 1984:1-7.
21. Weiss-Smith S, Deshpande G, Chung S, et al. The FDA drug safety surveillance program: adverse event reporting trends. Arch Intern Med. 2011;171:591-593.
22. Horwitz RI, Feinstein AR. The problem of protopathic bias in case-control studies. Am J Med. 1980;68:255-258.
23. Bailie GR. Comparison of serious adverse events from intravenous iron products in the United States. Am J Health-Syst Pharm. 2011. In press.