| アブストラクト | BACKGROUND: Epileptic seizures are a serious neurological event that can be triggered by various medications, posing significant threats to patient safety and treatment compliance. With the increasing use of neurotoxic drugs such as antidepressants, antipsychotics, anti-infectives, and anticancer agents, drug-related epileptic seizures (DRES) have become an emerging concern in clinical pharmacovigilance. Despite growing awareness, limited real-world data exists on the age-specific risk patterns and onset timing of DRES. OBJECTIVE: This study aimed to investigate the incidence trends, high-risk drugs, age-specific differences, and time-to-onset profiles of drug-related epileptic seizures using the FDA Adverse Event Reporting System (FAERS) from 2004 to 2024. METHODS: A retrospective pharmacovigilance analysis was conducted using standardized MedDRA terms and RxNorm drug names. Disproportionality analysis via Reporting Odds Ratio (ROR) was applied to detect significant seizure-related safety signals. Subgroup analyses by age and time-to-onset distributions were performed, including Weibull survival modeling. RESULTS: A total of 29,389 seizure-related adverse events were identified, with a marked increase in reports after 2011. The 15-44 age group accounted for the highest proportion (34.2 %). Bupropion (ROR: 5.62; 95 % CI: 5.21-6.07), Tramadol (ROR: 4.48; 95 % CI: 4.12-4.88), and Interferon beta-1a (ROR: 4.16; 95 % CI: 3.81-4.54) demonstrated consistently elevated seizure risk across all age groups. Age-specific signals included Methotrexate in children (0-14 years; ROR: 12.45; 95 % CI: 8.97-17.28) and Tranexamic Acid in the elderly (>60 years; ROR: 9.32; 95 % CI: 6.81-12.75). Eleven drugs not labeled for seizure risk in FDA documents, such as Meropenem and Indapamide, emerged as novel safety signals. Time-to-onset analysis showed that most drug-related seizure events occurred within 30 days of initiation, and Weibull modeling confirmed an early-failure time pattern across all age groups. CONCLUSION: This study provides real-world evidence on the epidemiological characteristics, age-related drug risk heterogeneity, and early-onset patterns of DRES. It highlights the need for individualized pharmacovigilance and regulatory updates to address under-recognized neurotoxic risks, particularly in vulnerable age groups. These findings contribute critical insights into safer prescribing practices and improved post-marketing surveillance. |
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