NDT Advance Access originally published online on March 29, 2005
Nephrology Dialysis Transplantation 2005 20(6):1279; doi:10.1093/ndt/gfh552
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Do we need to change our administration practice with regard to sodium ferric gluconate complex in glucose?
Sir,We read with considerable interest the original article by Chertow et al. [1] on the relative safety of parenteral iron formulations. They found that adverse drug effects were similar amongst recipients of high molecular weight iron dextran and sodium ferric gluconate complex in sucrose (SFGC), and significantly increased compared with recipients of low molecular weight dextran. In fact, there was even one death with the use of SFGC. This is a matter of concern to nephrologists as it has been accepted over the last couple of years that SFGC is similar to placebo in the incidence of serious anaphylactoid reactions [2]. Based on the study by Michael et al. [3], the product monograph of SFGC in the USA and India states that a test dose is not required before administration of the drug. Recently a large study has shown that SFGC could even be safely administered to 98% of patients sensitive to iron dextran [4].
As discussed by the authors, the present study has important limitations. It is retrospective, and there is no detailed clinical information. Adverse drug event reporting has been voluntary, depending on the discretion of the treating physician. Even so, the findings are worrying to the practising clinician. Although the authors have refrained from making any recommendation, we wonder whether any interim changes in the practice guidelines need to be initiated until a large prospective study is published.
Conflict of interest statement. None declared.
Department of Nephrology All India Institute of Medical Sciences New Delhi-111029 India Email: dmbhowmik{at}rediffmail.com
References
- Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. On the relative safety of parenteral iron formulations. Nephrol Dial Transplant 2004; 19: 1571–1575
[Abstract/Free Full Text] - Fishbane S. Safety in iron management. Am J Kidney Dis 2003; 41 [Suppl 5]: S18–S26
- 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[CrossRef][Web of Science][Medline]
- Coyne DW, Adkinson NF, 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[CrossRef][Web of Science][Medline]
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