Nephrol Dial Transplant (2004) 19: 1571-1575
Nephrol Dial Transplant Vol. 19 No. 6 © ERA-EDTA 2004; all rights reserved
Original Article
On the relative safety of parenteral iron formulations
1Division of Nephrology, Department of Medicine, University of California San Francisco, San Francisco, CA, USA, 2Oxford Kidney Unit, Churchill Hospital, Oxford, UK, 3Nebo a/s, Holbaek, Denmark and 4Department of Renal Medicine, Skaraborgs Hospital, Skövde, Sweden
Correspondence and offprint requests to: Glenn M. Chertow, MD, MPH, Department of Medicine Research, University of California San Francisco, UCSF Laurel Heights Suite 430, 3333 California Street, San Francisco, CA 94118-1211, USA. Email: chertowg{at}medicine.ucsf.edu
Background. Intravenous iron is usually required to optimize the correction of anaemia in persons with advanced chronic kidney disease and end-stage renal disease. Randomized clinical trials may have insufficient power to detect differences in the safety profiles of specific formulations.
Methods. We obtained data from the US Food and Drug Administration on reported adverse drug events (ADEs) related to the provision of three formulations of intravenous iron during 1998–2000. We estimated the relative risks [odds ratios (OR)] of ADEs associated with the use of higher molecular weight iron dextran and sodium ferric gluconate complex compared with lower molecular weight iron dextran using 2 x 2 tables.
Results. The total number of reported parenteral iron-related ADEs was 1981 among 
21 060 000 doses administered, yielding a rate of 9.4 x 10–5, or 94 per million. Total major ADEs were significantly increased among recipients of higher molecular weight iron dextran (OR 5.5, 95% CI 4.9–6.0) and sodium ferric gluconate complex (OR 6.2, 95% CI 5.4–7.2) compared with recipients of lower molecular weight iron dextran. We observed significantly higher rates of life-threatening ADEs, including death, anaphylactoid reaction, cardiac arrest and respiratory depression among users of higher molecular weight compared with lower molecular weight iron dextran. There was insufficient power to detect differences in life-threatening ADEs when comparing lower molecular weight iron dextran with sodium ferric gluconate complex.
Conclusions. Parenteral iron-related ADEs are rare. Using observational data, overall and most specific ADE rates were significantly higher among recipients of higher molecular weight iron dextran and sodium ferric gluconate complex than among recipients of lower molecular weight iron dextran. These data may help to guide clinical practice, as head-to-head clinical trials comparing different formulations of intravenous iron have not been conducted.
Keywords: adverse drug events; iron dextran; parenteral iron; sodium ferric gluconate complex
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