Drug-induced Neuropsychiatric Adverse Events Using Post-Marketing Surveillance.
Adverse events
Japanese Adverse Drug Event Report (JADER) database
reporting odds ratio
spontaneous reporting system
Journal
Current reviews in clinical and experimental pharmacology
ISSN: 2772-4336
Titre abrégé: Curr Rev Clin Exp Pharmacol
Pays: Netherlands
ID NLM: 9918227368306676
Informations de publication
Date de publication:
2022
2022
Historique:
received:
13
07
2020
revised:
24
11
2020
accepted:
06
01
2021
pubmed:
17
2
2021
medline:
5
4
2022
entrez:
16
2
2021
Statut:
ppublish
Résumé
Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs, including neuraminidase inhibitors (NIs). However, the information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify the drugs associated with abnormal behavior using a spontaneous reporting system database. We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed, and the reporting odds ratio at 95% confidence interval were calculated. A total of 1,144 reports of abnormal behavior were identified. The signals were detected through the association of 4 neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with the abnormal behaviour. These signals were stronger for oseltamivir than other neuraminidase inhibitors. The signals were also detected for acetaminophen and montelukast. Our results should be able to raise physicians' awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.
Sections du résumé
BACKGROUND
Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs, including neuraminidase inhibitors (NIs). However, the information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify the drugs associated with abnormal behavior using a spontaneous reporting system database.
METHODS
We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed, and the reporting odds ratio at 95% confidence interval were calculated.
RESULTS
A total of 1,144 reports of abnormal behavior were identified. The signals were detected through the association of 4 neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with the abnormal behaviour. These signals were stronger for oseltamivir than other neuraminidase inhibitors. The signals were also detected for acetaminophen and montelukast.
CONCLUSION
Our results should be able to raise physicians' awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.
Identifiants
pubmed: 33588740
pii: CCP-EPUB-114195
doi: 10.2174/1574884716666210215104540
pmc: PMC10495609
doi:
Substances chimiques
Oseltamivir
20O93L6F9H
Zanamivir
L6O3XI777I
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
144-148Informations de copyright
Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.
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