NDT Advance Access originally published online on April 19, 2005
Nephrology Dialysis Transplantation 2005 20(7):1438-1442; doi:10.1093/ndt/gfh811
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Benchmarking iron dextran sensitivity: reactions requiring resuscitative medication in incident and prevalent patients
1 Division of Nephrology and Hypertension, University of Miami School of Medicine, Miami, FL and 2 Department of Medicine, University of Arizona College of Medicine, Tucson, AZ, USA
Correspondence and offprint requests to: David B. Van Wyck, MD, Kidney Health Institute, LLC, 6720 North Nanini Drive, Tucson, AZ 85704-6128, USA. Email: dvanwyck{at}sprynet.com
Background. Reliable information on the incidence of severe reactions to iron dextran is limited. Administration of agents of resuscitation in acute anaphylaxis may serve as a marker to quantify life-threatening adverse drug reactions.
Methods. To determine the incidence of the most serious reactions to intravenous (i.v.) iron dextran, we searched the Gambro Healthcare US medical database for evidence of same-day administration of both i.v. iron dextran and parenteral adrenaline, corticosteroids or antihistamines. We confirmed each case as an iron dextran sensitivity reaction by direct inquiry. We also determined the total reported number of suspected adverse iron dextran reactions.
Results. During the 16 month study period, we determined that 1 066 099 doses of i.v. iron dextran were given to 48 509 patients, including 20 213 patients who had not previously received iron dextran (iron dextran naïve). We identified seven patients who experienced reactions requiring resuscitative agents, all in response to a test dose (five patients) or first therapeutic dose (two patients), and therefore all in the iron-naïve (incident) group. Thus, we found the incidence of iron dextran reactions requiring resuscitative agents to be 0.035% (7 out of 20 213). No reaction was fatal. In a combined group of incident and prevalent patients, we found 337 total reports of suspected adverse reactions to iron dextran, without regard to severity of reaction, yielding an overall per patient adverse drug event (ADE) rate of 0.69% (337 out of 48 509) and per exposure rate of 0.03% (337 out of 1 066 099).
Conclusions. The incidence of reactions to iron dextran requiring resuscitative medications, per exposure or per patient, is 
0.035%. Reactions of this severity occur after either the test dose or first dose of iron dextran.
Keywords: adverse reactions; anaemia; anaphylaxis; chronic renal failure; iron dextran; iron deficiency
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