A VigiBase Descriptive Study of Fluoroquinolone-Associated Peripheral Nervous System Disorders.
VigiBase
fluoroquinolones
peripheral neuropathy
safety concerns
Journal
Pharmaceuticals (Basel, Switzerland)
ISSN: 1424-8247
Titre abrégé: Pharmaceuticals (Basel)
Pays: Switzerland
ID NLM: 101238453
Informations de publication
Date de publication:
26 Jan 2022
26 Jan 2022
Historique:
received:
30
12
2021
revised:
21
01
2022
accepted:
21
01
2022
entrez:
26
2
2022
pubmed:
27
2
2022
medline:
27
2
2022
Statut:
epublish
Résumé
Recent drug safety concerns described fluoroquinolone (FQ)-induced peripheral nervous system reactions. The objective of this study was to characterize such reports from VigiBase. The analysis included FQ-induced peripheral nervous system disorder adverse drug reaction (ADR) reports (up to July 2019). We looked into the disproportionality data in terms of proportional reporting ratio (PRR) and information component (IC) values, and descriptive analysis was performed for FQ-ADRs positive associations (ADRs, suspected FQs, potential risk factors, such as associated therapy and underlying disease). Disproportionality analysis revealed 4374 reports (3531 serious) with peripheral nervous system ADRs associated with at least three FQs (neuropathy peripheral, 5492; neuralgia, 481; polyneuropathy, 220; sensory loss, 99; peripheral sensorimotor neuropathy, 39). Among these, both time-to-onset and duration of reaction were mostly between 1-7 days and ≥30 days. Most of the ADRs were not recovered/resolved at the time of reporting. The results augment the existing data on FQ safety concerns, specifically their potential effect on the nervous system.
Sections du résumé
BACKGROUND
BACKGROUND
Recent drug safety concerns described fluoroquinolone (FQ)-induced peripheral nervous system reactions. The objective of this study was to characterize such reports from VigiBase.
METHODS
METHODS
The analysis included FQ-induced peripheral nervous system disorder adverse drug reaction (ADR) reports (up to July 2019). We looked into the disproportionality data in terms of proportional reporting ratio (PRR) and information component (IC) values, and descriptive analysis was performed for FQ-ADRs positive associations (ADRs, suspected FQs, potential risk factors, such as associated therapy and underlying disease).
RESULTS
RESULTS
Disproportionality analysis revealed 4374 reports (3531 serious) with peripheral nervous system ADRs associated with at least three FQs (neuropathy peripheral, 5492; neuralgia, 481; polyneuropathy, 220; sensory loss, 99; peripheral sensorimotor neuropathy, 39). Among these, both time-to-onset and duration of reaction were mostly between 1-7 days and ≥30 days. Most of the ADRs were not recovered/resolved at the time of reporting.
CONCLUSION
CONCLUSIONS
The results augment the existing data on FQ safety concerns, specifically their potential effect on the nervous system.
Identifiants
pubmed: 35215256
pii: ph15020143
doi: 10.3390/ph15020143
pmc: PMC8876022
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Iuliu Hațieganu University of Medicine and Pharmacy
ID : PCD 1529/32/18.01.19
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