Systemic quinolones and risk of acute liver failure I: Analysis of data from the US FDA adverse event reporting system.
FDA Adverse Event Reporting System
acute hepatic failure
acute liver failure
hepatotoxicity
quinolones
Journal
JGH open : an open access journal of gastroenterology and hepatology
ISSN: 2397-9070
Titre abrégé: JGH Open
Pays: Australia
ID NLM: 101730833
Informations de publication
Date de publication:
Jul 2021
Jul 2021
Historique:
received:
22
01
2021
revised:
18
03
2021
accepted:
18
05
2021
entrez:
15
7
2021
pubmed:
16
7
2021
medline:
16
7
2021
Statut:
epublish
Résumé
Quinolones are a potent and globally popular group of antibiotics that are used to treat a wide range of infections. Some case reports have raised concern about their possible association with acute hepatic failure (AHF). Data from the US FDA Adverse Event Reporting System were evaluated for signals of AHF in association with systemically administered quinolone antibiotics. AHF reports between 1969 and 2019q2, with a focus on 2010-2019q2, were analyzed. Specifically, AHF reports linked to non-quinolone antibiotics of known hepatotoxicity were compared to reports with non-quinolone, non-hepatotoxic (reference) antibiotics; and AHF reports with quinolones were also compared to reports with the same group of reference antibiotics. Two disproportionality signal detection techniques (proportional reporting ratio, PRR, and empirical Bayes geometric mean, EBGM) were used to assess the AHF signal for both analyses. Only ciprofloxacin showed a marginal and significant AHF signal (PRR: 1.85 [1.21, 2.81]; EBGM: 1.54 [1.06, 1.81]); moxifloxacin, levofloxacin, and ofloxacin showed weak and nonsignificant signals. Further pharmacovigilance studies are required to confirm the association between ciprofloxacin and AHF seen in the present analysis.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
Quinolones are a potent and globally popular group of antibiotics that are used to treat a wide range of infections. Some case reports have raised concern about their possible association with acute hepatic failure (AHF). Data from the US FDA Adverse Event Reporting System were evaluated for signals of AHF in association with systemically administered quinolone antibiotics.
METHODS
METHODS
AHF reports between 1969 and 2019q2, with a focus on 2010-2019q2, were analyzed. Specifically, AHF reports linked to non-quinolone antibiotics of known hepatotoxicity were compared to reports with non-quinolone, non-hepatotoxic (reference) antibiotics; and AHF reports with quinolones were also compared to reports with the same group of reference antibiotics. Two disproportionality signal detection techniques (proportional reporting ratio, PRR, and empirical Bayes geometric mean, EBGM) were used to assess the AHF signal for both analyses.
RESULTS
RESULTS
Only ciprofloxacin showed a marginal and significant AHF signal (PRR: 1.85 [1.21, 2.81]; EBGM: 1.54 [1.06, 1.81]); moxifloxacin, levofloxacin, and ofloxacin showed weak and nonsignificant signals.
CONCLUSION
CONCLUSIONS
Further pharmacovigilance studies are required to confirm the association between ciprofloxacin and AHF seen in the present analysis.
Identifiants
pubmed: 34263072
doi: 10.1002/jgh3.12585
pii: JGH312585
pmc: PMC8264239
doi:
Types de publication
Journal Article
Langues
eng
Pagination
778-784Informations de copyright
© 2021 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
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