This investigator-initiated study was supported by a grant from Protherics Inc., manufacturer of FabAV, to the Denver Health Hospital Authority. No author or other employee of the Denver Health Hospital Authority received direct or indirect compensation as a result of this grant or study. Industry representatives did not participate in the design, execution, or writing of the study, nor did they control the decision to publish the results.
Progressive Clinical Practice
Incidence of Immediate Hypersensitivity Reaction and Serum Sickness Following Administration of Crotalidae Polyvalent Immune Fab Antivenom: A Meta-analysis
Version of Record online: 9 FEB 2012
© 2012 by the Society for Academic Emergency Medicine
Academic Emergency Medicine
Volume 19, Issue 2, pages 121–131, February 2012
How to Cite
Schaeffer, T. H., Khatri, V., Reifler, L. M. and Lavonas, E. J. (2012), Incidence of Immediate Hypersensitivity Reaction and Serum Sickness Following Administration of Crotalidae Polyvalent Immune Fab Antivenom: A Meta-analysis. Academic Emergency Medicine, 19: 121–131. doi: 10.1111/j.1553-2712.2011.01276.x
The authors have no potential conflicts of interest to disclose.
Supervising Editor: Shahriar Zehtabchi, MD.
- Issue online: 9 FEB 2012
- Version of Record online: 9 FEB 2012
- Received April 7, 2011; revisions received July 11 and August 19, 2011; accepted August 20, 2011.
Vol. 19, Issue 3, 368, Version of Record online: 21 MAR 2012
ACADEMIC EMERGENCY MEDICINE 2012; 19:121–131 © 2012 by the Society for Academic Emergency Medicine
Objectives: Crotalidae polyvalent immune Fab (ovine) (FabAV) is commonly used in the treatment of symptomatic North American crotaline snake envenomation. When approved by the U.S. Food and Drug Administration in 2000, the incidences of immediate hypersensitivity reactions and serum sickness were reported as 0.14 and 0.18, respectively. The objective of this meta-analysis was to evaluate the incidence of immediate hypersensitivity reactions and serum sickness reported in studies of patients treated with FabAV therapy after North American crotaline envenomation.
Methods: The authors searched PubMed, Ovid MEDLINE, and EMBASE from January 1, 1997, to September 20, 2010, for English-language medical literature and cross-referenced bibliographies of reviewed articles. The published abstracts of the major toxicology conferences were also searched. All prospective and retrospective cohort studies with patients receiving FabAV therapy for North American crotaline envenomations were eligible for data abstraction. Two content experts reviewed full-text articles and extracted relevant study design and outcome data. Proportions of immediate hypersensitivity and serum sickness for each study were analyzed in a random-effects model to produce an overall estimate of immediate hypersensitivity and serum sickness incidence associated with FabAV administration.
Results: The literature search revealed 11 unique studies of patients who received FabAV that contained information on immediate hypersensitivity reactions and serum sickness. The meta-analysis produced a combined estimate of the incidence of immediate hypersensitivity of 0.08 (95% confidence interval [CI] = 0.05 to 0.11) and a combined estimate of the incidence of serum sickness of 0.13 (95% CI = 0.07 to 0.21).
Conclusions: In this systematic literature review and meta-analysis, the combined estimates of the incidence of immediate hypersensitivity reactions and serum sickness from FabAV in the treatment of symptomatic North American crotaline envenomations appear to be lower than previously reported, at 0.08 and 0.13, respectively.