Eye disorders associated with newer antiepileptic drugs: A real-world disproportionality analysis of FDA adverse event reporting system

Background: Newer antiepileptic drugs such as levetiracetam, lacosamide, topiramate, gabapentin, oxcarbazepine, lamotrigine, and zonisamide are prescribed by physicians for the treatment of epilepsy. These drugs are also associated with a series of eye disorders. However, very few studies have systemically compared eye disorders associated with newer AEDs in a large sample of patients diagnosed with epilepsy. Objective: This study aimed to evaluate the association between eye disorders and several newer AEDs, and also to examine the differences in the frequency of adverse events across individual AEDs through data mining of the self-reporting US Food and Drug Administration Adverse Event Report System (FAERS) database. Methods: The definition relied upon system organ class and preferred terms according to the Medical Dictionary for Regulatory Activities. Disproportionality analysis was used to detect the risk signals from the FAERS database. The proportional reporting ratio, and chi 2 (chi-square) values were calculated to assess the association between AEs and AED use. Results: FAERS reports for 158,095 cases from January 1 of 2015 to September 30 of 2020 were included. AEDs were associated with a series of eye-related AEs that were defined by 106 preferred terms and could be classified into 10 aspects. Conclusion: There is variation in the types and severity of eye-related AEs across individual AEDs. Typically, topiramate and lamotrigine are more likely to cause serious eye-related AEs. In contrast, lacosamide rarely results in any severe eye-related AEs, and only diplopia and metamorphopsia are significant. levetiracetam tends to produce ocular neuromuscular disorder-related AEs. Macula-related AEs are associated with gabapentin. zonisamide appears to be closely associated with choroidal effusion and angle-closure glaucoma. oxcarbazepine is primarily associated with several cornea-related AEs.