title: On the relative safety of parenteral iron formulations.
abstract: 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 approximately 21,060,000 doses administered, yielding a rate of 9.4 x 10(-5), or approximately 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.
authors.affiliation: Division of Nephrology, Department of Medicine, University of California San Francisco, 94118-1211, USA. chertowg@medicine.ucsf.edu
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.forename: Phillip D
authors.initials: PD
authors.lastname: Mason
authors.forename: Odd
authors.initials: O
authors.lastname: Vaage-Nilsen
authors.forename: Jarl
authors.initials: J
authors.lastname: Ahlmén
mesh_terms: D005290:Ferric Compounds / Q000009:adverse effects*; D006801:Humans; D007505:Iron-Dextran Complex / Q000009:adverse effects*; D007676:Kidney Failure, Chronic / Q000628:therapy; D016017:Odds Ratio; D006435:Renal Dialysis
chemical_list: D005290:Ferric Compounds; D007505:Iron-Dextran Complex; C035552:ferric gluconate