Sodium ferric gluconate complex in sucrose: Safer intravenous iron therapythan iron dextrans

Use of recombinant human erythropoietin in patients with end-stage renal di sease has highlighted iron deficiency as the major cause of resistant anemi a. The current mainstay of intravenous (IV) iron replacement therapy, iron dextran, has been shown in prior studies to have a risk of serious life-thr eatening anaphylaxis of just under I per 100 patients exposed. The current study assessed the safety profile of an alternative IV iron, sodium ferric gluconate complex in sucrose (Ferrlecit), as compared with iron dextrans, S odium ferric gluconate complex in sucrose, a unique chemical preparation, h as been in use since 1959, principally in Europe, at a rate of approximatel y 2.7 million IV doses per year (1992 to 1996) in Germany and Italy alone. For iron dextran, usage in the United States was comparable-principally ren al hemodialysis-and estimated from market sources at 3.0 million doses per year (1995), From 1976 to 1996, there were 74 allergic adverse events repor ted for sodium ferric gluconate complex in sucrose to the World Health Orga nization (WHO), German Health Bureau, and the manufacturer (all combined). For the years 1992 to 1996, sodium ferric gluconate complex in sucrose had an allergy event reporting rate of 3.3 allergy episodes per million doses p er year compared with a similar rate of 8.7 reported allergy events per mil lion doses per year for iron dextran in the United States in 1995, Case fat alities for sodium ferric gluconate complex in sucrose and iron dextran wit hin these reports were then compared. For sodium ferric gluconate complex i n sucrose, there were no reports of deaths over the entire period (1976 to 1996), However, for iron dextrans, there were 31 fatalities among 196 aller gy/anaphylaxis cases reported in the United States between 1976 and 1996, y ielding a case-fatality rate of 15.8%, These data show that sodium ferric g luconate complex in sucrose, when compared with iron dextrans in comparably sized patient usage populations with similar total rates of reporting of a llergic events, has a significantly lower reported mortality rate (P < 0.00 1). Thus, the data justify usage of sodium ferric gluconate complex in sucr ose as the safer iron replacement therapeutic agent. (C) 1999 by the Nation al Kidney Foundation, Inc.