Evidence map›Paper›PMID 34263072›Full record

ArticleJGH open : an open access journal of gastroenterology and hepatology2021

Systemic quinolones and risk of acute liver failure I: Analysis of data from the US FDA adverse event reporting system.

Mohamed Kadry Taher, Abdallah Alami, Christopher A Gravel, Derek Tsui, Lise M Bjerre, Franco Momoli, Donald R Mattison, Daniel Krewski

Open access · goldAbstract read
In one paragraph

Article in JGH open : an open access journal of gastroenterology and hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Safety of fluoroquinolones.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2024
    Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Mohamed Kadry TaherMcLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine University of Ottawa Ottawa ON Canada.ORCID https://orcid.org/0000-0002-5754-7512
Abdallah AlamiRisk Sciences International Ottawa ON Canada.
Christopher A GravelMcLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine University of Ottawa Ottawa ON Canada.ORCID https://orcid.org/0000-0002-7780-3392
Derek TsuiRisk Sciences International Ottawa ON Canada.
Lise M BjerreSchool of Epidemiology and Public Health University of Ottawa Ottawa ON Canada.
Franco MomoliSchool of Epidemiology and Public Health University of Ottawa Ottawa ON Canada.
Donald R MattisonMcLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine University of Ottawa Ottawa ON Canada.
Daniel KrewskiMcLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine University of Ottawa Ottawa ON Canada.
University of Ottawa · CANutrition International · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimQuinolones 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.

methodsAHF 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.

resultsOnly 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.

conclusionFurther pharmacovigilance studies are required to confirm the association between ciprofloxacin and AHF seen in the present analysis.

Indexed as

acute hepatic failureacute liver failureFDA Adverse Event Reporting Systemhepatotoxicityquinolones

Identifiers

PMID34263072
PMCPMC8264239
OpenAlexW3170989721

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.