Eye Disorders Associated with newer Antiepileptic drugs: A real-world disproportionality analysis of FDA Adverse Reporting System events

Abstract

, Abstract Background Newer antiepileptic drugs (AEDs), such as Levetiracetam (LEV), Lacosamide(LCM), Topiramate(TPM), Gabapentin(GBP), Oxcarbazepine(OXA), Lamotrigine(LTG) and Zonisamide(ZNS), are prescribed frequently for epilepsy by physicians. Simultaneously, they are known to be associated with a series of eye disorders. But very few studies have systemically compared eye disorders of newer AEDs in a large sample of patients diagnosed with epilepsy. Objective The aim of this study is to evaluate the association between eye disorders and several newer antiepileptic drugs (AEDs), including LEV, LTG, TPM, GBP, OXA, LCM, ZNS, as well as to look for differences in the frequency of AEs across individual AEDs, by data-mining a self-reporting database, the FDA Adverse Event Report System (FAERS). Methods The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis was used to detect the risk signals from the data in the US Food and Drug Administration (FDA) adverse event reporting system database (FAERS). The reporting odds ratio (ROR), the proportional reporting ratio (PRR) and