Data analysis of adverse events of clobazam among children based on foreign pharmacovigilance safety spontaneous reporting system

doi:10.19803/j.1672-8629.20230226

Abstract

Abstract: Objective To analyze the occurrence of adverse drug reactions/events (ADR/ADE) in real world clinical use of clobazam among children aged 0 to 17, and to provide data for clinical use of clobazam in pediatrics. Methods The data on reports of ADR/ADE of clobazam in the population aged 0 to 17 was retrieved from the WHO global database (VigiBase) of reported potential side effects of medicinal products (from inception to November 16, 2022), FDA Adverse Event Reporting System (FAERS) database (from January 1, 2004 to November 17, 2022) and from European Union Drug Regulating Authorities Pharmacovigilance (Eudra Vigilance) database (from inception to November 13, 2022). Descriptive analysis and proportional reporting ratio (PRR) data mining algorithms were used to detect ADR/ADE signals. Results A total of 31 990 ADR/ADE reports were retrieved for clobazam, including 3 885 from Eudra Vigilance, 19 066 from FAERS, and 9 039 from VigiBase. All the three databases showed that clobazam-related reports accounted for a relatively higher proportion (13.08% ~ 14.54%) of those relating to children aged 3 to 11, and clobazam was involved in more ADR/ADE reports related to the nervous system disorders and psychiatric disorders. In the Eudra Vigilance database, the incidence of nervous system disorders, psychiatric and gastrointestinal disorders and skin & subcutaneous tissue diseases was higher in older children, while respiratory & thoracic and mediastinal disorders were more common in younger children. FAERS data mining showed that the PRR value of ADR/ADE signals of infant relaxation syndrome among children aged 0 to 2 was as high as 718.58, which was worthy of attention. Besides, the PRR values of aggressiveness and cognitive impairment were higher in children ages 3 to 11, so were the PRR values of appetite decline and aggressiveness in children ages 12 to 17. Conclusion In clinical use of clobazam in pediatrics, attention should be paid to the ADR/ADE related to the nervous system, psychiatry, skin & subcutaneous tissue and the respiratory system. Clobazam may have an effect on newborns, so it should be used with caution in children under 2 years old, and in pregnant and lactating women.

Key words: clobazam, children, adverse drug reaction/event, nervous system disorders, psychiatric disorders, data analysis

CLC Number:

R971
R994.11

PENG Jing, TUO Yali, LI Qiaoling, ZHOU Rong, LI Xinlin, PENG Hui. Data analysis of adverse events of clobazam among children based on foreign pharmacovigilance safety spontaneous reporting system[J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1264-1268.

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