Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients

Current Medical Research and Opinion

Volumn 29, Issue 2, 2013, Pages 141-147

  Lee, Eun Sil ^a   Park, Bo Ra ^a   Kim, Jeong Sig ^a   Choi, Gyu Yeon ^a   Lee, Jeong Jae ^a   Lee, Im Soon ^a  

^a Soonchunhyang University   (South Korea)

Author keywords

Adverse drug reaction; Anemia, iron deficiency; Gynecology; Iron sucrose; Similar

Indexed keywords

FEREX; IRON SACCHARATE; UNCLASSIFIED DRUG; VENOFERRUM;

ADULT; ADVERSE OUTCOME; ARTICLE; CESAREAN SECTION; CLINICAL PRACTICE; CONTROLLED STUDY; CYSTECTOMY; DELIVERY; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; HYSTERECTOMY; INJECTION SITE REACTION; IRON DEFICIENCY ANEMIA; MAJOR CLINICAL STUDY; MYOMECTOMY; NAUSEA; PHLEBITIS; PHYSICAL CHEMISTRY; PUERPERIUM; SHELF LIFE;

ADMINISTRATION, INTRAVENOUS; ADULT; ANEMIA, IRON-DEFICIENCY; CONFIDENCE INTERVALS; FEMALE; FERRIC COMPOUNDS; GLUCARIC ACID; HEMATINICS; HUMANS; MEDICAL AUDIT; MIDDLE AGED; OBSTETRIC SURGICAL PROCEDURES; POSTPARTUM PERIOD; PREGNANCY; PREGNANCY COMPLICATIONS, HEMATOLOGIC; REPUBLIC OF KOREA; RETROSPECTIVE STUDIES;

EID: 84872225362     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2012.760444     Document Type: Article

References (33)

1. Beglinger C, Breymann C. Traitement de la carence en fer. Swiss Med Forum. 2010;10
2. Breymann C. Iron supplementation during pregnancy. Fetal Maternal Med Review. 2002;13:1-29
3. Milman N. Prepartum anemia: prevention and treatment. Ann Hematol 2008;87:949-59
4. Bruner AB, Joffe A, Duggan AK, et al. Randomized study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls. Lancet 1996;348:992-6
5. Hercberg S, Galan P, Preziosi P, et al. Consequence of iron deficiency in pregnant women: Current issue. Clin Drug Invest 2000;19(Suppl 1):1-7
6. Mozaheb Z, Khayami M, Sayadpoor D. Iron balance in regular blood donors. Transfus Med Hemother 2011;38:190-4
7. Madore F, White CT, Foley RN, et al. Clinical practice guidelines for assessment and management of iron deficiency. Kidney Int 2008;74(Suppl 110):S7-11
8. Gasche C, Evstatiev R, Haas T, et al. Diagnosis and treatment of iron deficiency and anaemia in inflammatory bowel diseases. Consensus of the Austrian IBD Working Party. Z Gastroenterol 2011;49:627-32
9. Rizzo JD, Somerfield MR, Hagerty KL, et al. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology Clinical Practice Guideline Update. J Clin Oncol 2008;26:132-49
10. Cancer-and chemotherapy-induced anemia. In: NCCN Clinical Practice Guidelines in Oncology (NCCN GuidelinesTM). 2010 July
11. Breymann C, Bian XM, Blanco-Capitol R, et al. Expert recommendations for the diagnosis and treatment of iron-deficiency anemia during pregnancy and the postpartum period in the Asia-Pacific region. J Perinat Med 2011;39:113-21
12. Westad S, Backe B, Salvesen KA, et al. A 12-week randomised study comparing intravenous iron sucrose versus oral ferrous sulphate for treatment of postpartum anemia. Acta Obstet Gynecol Scand 2008;87:916-23
13. Armand-Ugó n R, Cheong T, Matapandewu G, et al. Anaemia Working Group Espana. Efficacy of intravenous iron for treating postpartum anemia in lowresource African countries: a pilot study in Malawi. J Womens Health 2011;20:123-7
14. 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;37:119-24
15. Bailie GR, Verhoef JJ. Differences in the reporting rates of serious allergic adverse events from intravenous iron by country and population. Clin Adv Hematol Oncol 2012;10:101-8
16. Schellekens H, Klinger E, Mü hlebach S, et al. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol 2011;59:176-83
17. Toblli JE, Cao G, Oliveri L, et al. Differences between original intravenous iron sucrose and iron sucrose similar preparation. Arzneimittelforschung 2009;59:176-90
18. Toblli JE, Cao G, Oliveri L, et al. Comparison of oxidative stress and inflammation induced by different intravenous iron sucrose similar preparations in a rat model. Inflamm Allergy Drug Targets 2012;11:66-78
19. Kang MK, Band SY, Kim JY, et al. Intravenous iron in the treatment of postoperative anemia following obstetric and gynecologic surgery. Korean J Obstet Gynecol 2006;4919:64-9
20. Locatelli F. Section III. Treatment of renal anaemia. Nephrol Dial Transplant. 2004;19:1116-31
21. Reed I, Charytan C, Yee I. The safety of intravenous iron sucrose use in the elderly patient. Consult Pharm 2007;22:230-8
22. Geisser P, Baer, M, Schaub, E. Structure/histotoxicity relationship of parenteral iron preparations. Arzeimittelforschung 1992;42:1439-52
23. United States Pharmacopeial Convention: Iron Sucrose Injection, official monograph in: The United States Pharmacopeia. United States Pharmacopeial Convention: Tockville, MD, US 2008;31:2449-51
24. Danielson, B.G. Structure, chemistry, and pharmacokinetics of intravenous iron agents. J. Am Soc Nephro 2004;15(Suppl 2):S93-8
25. Rottembourg J, Kadri A, Leonard E, et al. Do two intravenous iron sucrose preparations have the same efficacy? Nephrol Dial Transplant 2011;26:3262-7
26. Stein J, Dihnass A, Chow KU. Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator. Cur Med Res Opin 2012;28:1-3
27. Venofer PI 2003, Vifor (International) Inc
28. Macdougall IC. Strategies for iron supplementation: oral versus intravenous. Kidney Int Suppl 1999;69:S61-6
29. McCord IM. Human disease, free radicals, and the oxidant/antioxidant balance. Clin Biochem 1993;26:351-7
30. Zanen AL, Adriaansen HI, van Bommel EFH, et al. Oversaturation of transferring after intravenous ferric gluconate (Ferrlecit-) in haemodialysis patients. Nephrol Dial Transplant 1996;11:820-4
31. Fishbane S. Safety in iron management. Am J Kidney Dis 2003;41:18-26
32. Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications. Mar 2011. EMA/CHMP/SWP/100094/2011. Accessed on 7 Oct 2012: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2011/04/WC500105048.pdf
33. Draft Guidance on Iron Sucrose. Mar 2012. Accessed on 7 Oct 2012: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM297630.pdf.