A real-world pharmacovigilance study of severe cutaneous adverse reactions associated with antiepileptic drug combination therapy: data mining of FDA adverse event reporting system

Chunyan Wei; Jingyi Zhang; Wanhong Yin; Aidou Jiang; Yin Liu; Bin Wu

doi:10.1080/14740338.2023.2147506

A real-world pharmacovigilance study of severe cutaneous adverse reactions associated with antiepileptic drug combination therapy: data mining of FDA adverse event reporting system

Expert Opin Drug Saf. 2023 Jan-Jun;22(6):509-515. doi: 10.1080/14740338.2023.2147506. Epub 2022 Nov 15.

Authors

Chunyan Wei^{1

2}, Jingyi Zhang¹, Wanhong Yin³, Aidou Jiang¹, Yin Liu¹, Bin Wu¹

Affiliations

¹ Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
² West China School of Pharmacy, Sichuan University, Chengdu, Sichuan, China.
³ Department of Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

PMID: 36373417
DOI: 10.1080/14740338.2023.2147506

Abstract

Background: The aim of this study was to evaluate the association between antiepileptic drug combination regimens and severe cutaneous adverse reactions (SCAR).

Research design and methods: We gathered cases indication with epilepsy based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2004 to 2021. Disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and the information component (IC).

Results: Out of 128,262 reports were collected from the FAERS database, 104,278 cases were in the antiepileptic drugs group, and 23,984 cases were in the other primary suspected drugs group. A total of 20 combination regimens were associated with increased association of SCAR, top five of them were topiramate-phenytoin (ROR 57.62, 95% CI 30.93-107.34), lamotrigine-valproic acid (ROR 52.93, 95% CI 47.09-59.49), diazepam-phenobarbital (ROR 39.61, 95% CI 20.01-78.38), zonisamide-valproic acid (ROR 36.57, 95% CI 19.16-69.80), lamotrigine-diazepam (ROR 35.22, 95% CI 15.70-79.00).

Conclusion: The antiepileptic agent combinations may increase the incidence of SCAR and should be carefully evaluated in clinical practice. It is recommended to choose the combination regimens which have lower SCAR reporting rate for patients.

Keywords: FAERS; Severe cutaneous adverse reactions; antiepileptic drug; combination therapy.