한국 내 항우울제 사용 시 안전성 확보를 위한 다국가 허가사항 비교 연구 = Comparative Analysis of International Regulatory Approvals for Ensuring the Safety of Antidepressants in Korea

다국어 초록 (Multilingual Abstract)

This study aims to compare the regulatory approvals and prescribing information of antidepressants in South Korea, the United States (U.S.), the United Kingdom, and Japan. A comparative analysis was conducted based on the most recent prescribing information from the regulatory agencies of the four countries as of June 30, 2024. Twenty antidepressants approved in South Korea were classified into selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants (TCA), and other antidepressants.
While overall consistency was observed in prescribing information among the four countries, notable differences existed in drug approvals and safety warnings.
Japan had the highest number of unapproved antidepressants, whereas South Korea had marketing authorization for 19 of the 20 studied agents. The U.S. Food and Drug Administration’s (FDA) Black Box Warning on suicide risk in young adults was incorporated into prescribing information across all four countries. However, certain safety warnings, such as hyperhidrosis associated with escitalopram and prolongation of the QT interval in the electrocardiogram risk for specific TCA, were absent from South Korea’s prescribing information. Despite broad similarities in antidepressant prescribing information, regulatory discrepancies contribute to country-specific variations. Given the increasing use of antidepressants among high-risk populations, including older adults and adolescents, further investigation is warranted to assess potential safety concerns and refine prescribing guidelines.
Continuous updates and harmonization efforts are essential to enhance patient safety and ensure evidence-based clinical decision-making.