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A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)
Version 1
: Received: 12 June 2024 / Approved: 12 June 2024 / Online: 12 June 2024 (23:52:54 CEST)
How to cite:
Kim, D.; Lee, S. A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS). Preprints2024, 2024060844. https://doi.org/10.20944/preprints202406.0844.v1
Kim, D.; Lee, S. A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS). Preprints 2024, 2024060844. https://doi.org/10.20944/preprints202406.0844.v1
Kim, D.; Lee, S. A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS). Preprints2024, 2024060844. https://doi.org/10.20944/preprints202406.0844.v1
APA Style
Kim, D., & Lee, S. (2024). A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS). Preprints. https://doi.org/10.20944/preprints202406.0844.v1
Chicago/Turabian Style
Kim, D. and Sukhyang Lee. 2024 "A Real-World Safety Profile in Neurological, Skin, and Sexual disorders of Antiepileptic Drugs Using Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS)" Preprints. https://doi.org/10.20944/preprints202406.0844.v1
Abstract
This study aims to examine the safety profile of antiepileptic drugs (AEDs) using real-world data, with a focus on neurological, skin, and sexual/reproductive disorders. Data were collected from AED-caused reports in the Korea Adverse Event Reporting System Database (KAERS-DB) from 2012 to 2022. Totally, 46,963 adverse drug reaction (ADR)-drug pairs were analyzed. At the system organ class level, the most frequently reported classes for sodium channel blockers (SCBs) were skin (37.9%), neurological (16.7%), and psychiatric disorders (9.7%). However, for non-SCBs, these were neurological (31.2%), gastrointestinal (22.0%), and psychiatric disorders (18.2%). The most common ADRs induced by SCBs were rash (17.8%), pruritus (8.2%), and dizziness (6.7%). In contrast, non-SCBs induced dizziness (23.7%), somnolence (13.0%), and nausea (6.3%). Among the most commonly reported ADRs, rash, pruritus, and urticaria occurred on average two days later with SCBs compared to non-SCBs. Sexual/reproductive disorders were reported at a frequency of 0.23%. SCBs were reported as the cause more frequently than non-SCBs (59.8% vs. 40.2%, Fisher’s exact test, p<0.0001). Based on real-world data, we identified the safety profiles of AEDs. AED-induced ADRs exhibited different patterns depending on the mechanism. Therefore, it is important to establish different pharmacovigilance strategies to ensure proper monitoring.
Medicine and Pharmacology, Pharmacology and Toxicology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
