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Neuropsychological adverse drug reactions of Remdesivir: analysis using VigiBase, the WHO global database of individual case safety reports

Authors
 S Lee  ;  J W Yang  ;  S Y Jung  ;  M S Kim  ;  D K Yon  ;  S W Lee  ;  H-C Kang  ;  E Dragioti  ;  K Tizaoui  ;  L Jacob  ;  A Koyanagi  ;  J-E Salem  ;  K Kostev  ;  A Lascu  ;  J I Shin  ;  J H Kim  ;  L Smith 
Citation
 EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, Vol.25(23) : 7390-7397, 2021-12 
Journal Title
EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES
ISSN
 1128-3602 
Issue Date
2021-12
MeSH
Adenosine Monophosphate / adverse effects ; Adenosine Monophosphate / analogs & derivatives* ; Adverse Drug Reaction Reporting Systems ; Alanine / adverse effects ; Alanine / analogs & derivatives* ; Bayes Theorem ; Cohort Studies ; Databases, Factual ; Humans ; Nervous System Diseases / chemically induced ; Nervous System Diseases / epidemiology* ; Pharmacovigilance ; Psychological Distress ; Stress, Psychological / chemically induced ; Stress, Psychological / epidemiology* ; World Health Organization
Abstract
Objective: Although remdesivir (GS-5734) has recently demonstrated clinical benefits against the pandemic outbreak of coronavirus disease 2019 (COVID-19), neuropsychological adverse reactions (ADRs) remain to be examined in real-world settings. Therefore, we aimed to identify and characterize the neuropsychological ADRs associated with remdesivir use.

Materials and methods: We obtained data for this international pharmacovigilance cohort study from individual case safety reports (ICSRs) in a World Health Organization database (VigiBase) from the first report on remdesivir on February 17, 2020, until August 30, 2020 (n=1,403,532). ADRs reported to be relevant to remdesivir were compared with the full database by using a Bayesian neural network method to calculate the information component (IC).

Results: A total of 2,107 reported cases of neuropsychological ADRs suspected to be associated with remdesivir were identified from among all ICSRs in the database during the observation period. Although 108 neuropsychological ADRs (64 neurologic events and 44 psychologic events) were reported in association with the medication, no statistically significant pharmacovigilance signal could be detected; the IC025 value was negative for all of the neuropsychological dysfunctions (anxiety [n=13, 0.62%], seizures [n=12, 0.57%], lethargy [n=6, 0.28%], agitation [n=5, 0.25%], cerebral infarction [n=3, 0.14%], ischemic stroke [n=3, 0.14%], and hemiparesis [n=3, 0.14%]).

Conclusions: Our study demonstrates that remdesivir, a novel drug applied to the treatment of COVID-19, does not have a significant association with adverse neurologic or psychiatric reactions in the real-world setting.
Files in This Item:
T202125316.pdf Download
DOI
10.26355/eurrev_202112_27435
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Hoon Chul(강훈철) ORCID logo https://orcid.org/0000-0002-3659-8847
Kim, Ji Hong(김지홍) ORCID logo https://orcid.org/0000-0001-5352-5423
Shin, Jae Il(신재일) ORCID logo https://orcid.org/0000-0003-2326-1820
Jung, Se Yong(정세용) ORCID logo https://orcid.org/0000-0003-1337-563X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/187792
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