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

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BACKGROUND Cutaneous toxicity is one of the most noteworthy adverse reactions of antiepileptic drugs. The aim of this study was to evaluate the association between antiepileptic drug combination regimens and… Click to show full abstract

BACKGROUND Cutaneous toxicity is one of the most noteworthy adverse reactions of antiepileptic drugs. 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 128262 reports were collected from the FAERS database, 104278 cases were in the antiepileptic drugs group, and 23984 cases were in the other primary suspected drugs group. The two groups had similar demographic characteristics. 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: ror; adverse reactions; combination; reporting; drug; antiepileptic drug

Journal Title: Expert opinion on drug safety
Year Published: 2022

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