Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA adverse event reporting system.
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
/ statistics & numerical data
Aged
Aged, 80 and over
Anti-Bacterial Agents
/ administration & dosage
Child
Child, Preschool
Female
Humans
Infant
Male
Middle Aged
Moxifloxacin
/ administration & dosage
Pharmacoepidemiology
Pharmacovigilance
Quinolones
/ administration & dosage
Retinal Detachment
/ chemically induced
Risk
Sensitivity and Specificity
United States
United States Food and Drug Administration
Young Adult
Drug safety
FAERS
FDA adverse event reporting system
pharmacovigilance
quinolones
retinal detachment
Journal
Expert opinion on drug safety
ISSN: 1744-764X
Titre abrégé: Expert Opin Drug Saf
Pays: England
ID NLM: 101163027
Informations de publication
Date de publication:
Feb 2022
Feb 2022
Historique:
pubmed:
14
10
2021
medline:
19
2
2022
entrez:
13
10
2021
Statut:
ppublish
Résumé
Quinolones comprise a class of antibiotics that are globally preferred for treating a wide range of bacterial infections due to their potency, broad coverage, favorable pharmacologic profile, and mostly mild to moderate adverse reactions. Spontaneous reports on adverse drug events (ADE) and data from some pharmacoepidemiologic studies have raised concerns regarding quinolones and risk of retinal detachment (RD). This study examined ADE reports submitted to FDA adverse event reporting system (FAERS) for evidence on quinolone-associated RD risk. We identified all RD reports in FAERS between 2010-2019. We compared ADE signals between quinolones and selected medications that were previously associated with RD, and with reference medications not known to cause RD. For signal detection, we used two techniques: the proportional reporting ratio (PRR) and multi-item gamma Poisson shrinker (MGPS), which are known for their higher sensitivity and specificity for ADE signal detection, respectively. Moxifloxacin showed a positive and significant PRR signal for RD [PRR: 2.54 (1.60, 4.04)], and a marginally significant EBGM signal [EBGM: 2.21 (1.41, 3.02)]. Moxifloxacin is the only quinolone showing a positive disproportionality signal for RD. Further epidemiologic research is needed to clarify the association between moxifloxacin and RD risk.
Sections du résumé
BACKGROUND
BACKGROUND
Quinolones comprise a class of antibiotics that are globally preferred for treating a wide range of bacterial infections due to their potency, broad coverage, favorable pharmacologic profile, and mostly mild to moderate adverse reactions. Spontaneous reports on adverse drug events (ADE) and data from some pharmacoepidemiologic studies have raised concerns regarding quinolones and risk of retinal detachment (RD). This study examined ADE reports submitted to FDA adverse event reporting system (FAERS) for evidence on quinolone-associated RD risk.
RESEARCH DESIGN AND METHODS
METHODS
We identified all RD reports in FAERS between 2010-2019. We compared ADE signals between quinolones and selected medications that were previously associated with RD, and with reference medications not known to cause RD. For signal detection, we used two techniques: the proportional reporting ratio (PRR) and multi-item gamma Poisson shrinker (MGPS), which are known for their higher sensitivity and specificity for ADE signal detection, respectively.
RESULTS
RESULTS
Moxifloxacin showed a positive and significant PRR signal for RD [PRR: 2.54 (1.60, 4.04)], and a marginally significant EBGM signal [EBGM: 2.21 (1.41, 3.02)].
CONCLUSION
CONCLUSIONS
Moxifloxacin is the only quinolone showing a positive disproportionality signal for RD. Further epidemiologic research is needed to clarify the association between moxifloxacin and RD risk.
Identifiants
pubmed: 34641748
doi: 10.1080/14740338.2022.1993187
doi:
Substances chimiques
Anti-Bacterial Agents
0
Quinolones
0
Moxifloxacin
U188XYD42P
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM