Neuropsychological Adverse Drug Reactions to Remdesivir: Results from the WHO International Pharmacovigilance Database

Lee, Sangbo, Yang, Jae Won, Jung, Se Yong, Kim, Min Seo, Yon, Dong Keon, Lee, Seung Won, Kang, Hoon-Chul, Dragioti, Elena, Tizaoui, Kalthoum, Jacob, Louis, Koyanagi, Ai, Salem, Joe-Elie, Kostev, Karel, Lascu, Ana, Shin, Jae Il, Kim, Ji Hong and Smith, Lee (2021) Neuropsychological Adverse Drug Reactions to Remdesivir: Results from the WHO International Pharmacovigilance Database. European Review for Medical and Pharmacological Sciences, 25 (23). pp. 7390-7397. ISSN 2284-0729

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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.

Item Type:	Journal Article
Keywords:	Remdesivir, Pharmacovigilance, VigiBase, Neuropsychological toxicities, Adverse drug reactions
Faculty:	Faculty of Science & Engineering
SWORD Depositor:	Symplectic User
Depositing User:	Symplectic User
Date Deposited:	13 Sep 2021 11:40
Last Modified:	17 Jan 2022 15:22
URI:	https://arro.anglia.ac.uk/id/eprint/706916

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