TY - JOUR
T1 - Analysis of fomepizole safety based on a 16-year post-marketing experience in France
AU - Rasamison, Riana
AU - Besson, Hélène
AU - Berleur, Marie Pierre
AU - Schicchi, Azzurra
AU - Mégarbane, Bruno
N1 - Funding Information:
The authors would like to thank Mrs. Alison Good (Scotland, UK) for her helpful review of the manuscript.
Publisher Copyright:
© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/7/2
Y1 - 2020/7/2
N2 - Introduction: Fomepizole has been recommended as first-line antidote to treat ethylene glycol and methanol poisoning. Despite more than 30 years of utilization, the safety of fomepizole when used clinically has not been well documented. Based on the long-standing clinical experience with fomepizole in France, we investigated its safety profile in patients treated for suspected toxic alcohol poisoning. Methods: We designed a 16-year post-marketing study to evaluate the indications for fomepizole prescriptions and to investigate its safety. Data were retrospectively collected using a standardized questionnaire sent each month by post to each French hospital that ordered fomepizole during the month before. The response rate to our survey was 59%. Results: Five hundred and thirty-six patients [188 females/348 males; age, 46 years [34–55] (median [25th–75th percentiles])] were treated with fomepizole [cumulative dose, 18.6 mg/kg [15.5–26.3] (1,268 mg [900-2,100])]. Ethylene glycol/methanol poisoning was confirmed in 275 patients (51%) while a nontoxic exposure was diagnosed in 147 patients (27%). Toxic alcohol poisoning was misdiagnosed in the remaining 114 patients (21%), before the assessment of an alternative poisoning or non-poisoning diagnosis. Fifty adverse reactions were attributed to fomepizole in 36 patients (7%) including general reactions (N = 22), local reactions (N = 22) and laboratory test impairments (N = 6). All were considered mild and transient. None required stopping fomepizole. The most frequent adverse effects were injection site pain/burning (N = 13), nausea/vomiting (N = 8), vessel puncture site inflammation (N = 7), drowsiness/confusion (N = 5) and serum aminotransferase elevation (N = 3). None of the fatalities (N = 37, 7%) or persistent symptoms on discharge (N = 9; 2%) was related to fomepizole. Conclusion: Our longitudinal cohort study supports the safety of fomepizole administered to treat presumed EG and methanol poisoning.
AB - Introduction: Fomepizole has been recommended as first-line antidote to treat ethylene glycol and methanol poisoning. Despite more than 30 years of utilization, the safety of fomepizole when used clinically has not been well documented. Based on the long-standing clinical experience with fomepizole in France, we investigated its safety profile in patients treated for suspected toxic alcohol poisoning. Methods: We designed a 16-year post-marketing study to evaluate the indications for fomepizole prescriptions and to investigate its safety. Data were retrospectively collected using a standardized questionnaire sent each month by post to each French hospital that ordered fomepizole during the month before. The response rate to our survey was 59%. Results: Five hundred and thirty-six patients [188 females/348 males; age, 46 years [34–55] (median [25th–75th percentiles])] were treated with fomepizole [cumulative dose, 18.6 mg/kg [15.5–26.3] (1,268 mg [900-2,100])]. Ethylene glycol/methanol poisoning was confirmed in 275 patients (51%) while a nontoxic exposure was diagnosed in 147 patients (27%). Toxic alcohol poisoning was misdiagnosed in the remaining 114 patients (21%), before the assessment of an alternative poisoning or non-poisoning diagnosis. Fifty adverse reactions were attributed to fomepizole in 36 patients (7%) including general reactions (N = 22), local reactions (N = 22) and laboratory test impairments (N = 6). All were considered mild and transient. None required stopping fomepizole. The most frequent adverse effects were injection site pain/burning (N = 13), nausea/vomiting (N = 8), vessel puncture site inflammation (N = 7), drowsiness/confusion (N = 5) and serum aminotransferase elevation (N = 3). None of the fatalities (N = 37, 7%) or persistent symptoms on discharge (N = 9; 2%) was related to fomepizole. Conclusion: Our longitudinal cohort study supports the safety of fomepizole administered to treat presumed EG and methanol poisoning.
KW - antidote
KW - Fomepizole
KW - poisoning
KW - safety
KW - toxic alcohol
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U2 - 10.1080/15563650.2019.1676899
DO - 10.1080/15563650.2019.1676899
M3 - Article
C2 - 31608703
AN - SCOPUS:85074333915
SN - 1556-3650
VL - 58
SP - 742
EP - 747
JO - Clinical Toxicology
JF - Clinical Toxicology
IS - 7
ER -