Schetz Daria, Sein Anand Jacek, Sein Anand Łukasz, Kocić Ivan
Department of Pharmacology, Faculty of Medicine, Medical University of Gdańsk, 80-210 Gdańsk, Poland.
Pomeranian Centre of Toxicology, 80-104 Gdańsk, Poland.
Pharmaceuticals (Basel). 2024 Dec 19;17(12):1714. doi: 10.3390/ph17121714.
Antidepressants such as SSRIs and SNRIs are widely prescribed; however, significant concerns exist regarding psychiatric adverse drug reactions (ADRs), particularly suicidal ideation, suicide attempts, and completed suicides. This study analyzes pharmacovigilance (PhV) data from the EudraVigilance database to assess the frequency of psychiatric ADRs, including suicide-related events, associated with six commonly used antidepressants. Another aim of the study is to evaluate the utility of pharmacovigilance data in providing insights into real-world risks associated with medications, highlighting the importance of improving the ADR reporting system and ensuring the completeness and reliability of ADR reports. Data from December 2001 to September 2024 were analyzed for duloxetine, citalopram, escitalopram, fluoxetine, venlafaxine, and sertraline. Reports were categorized by age, gender, and source, focusing on psychiatric ADRs and suicide-related events, including completed suicides and suicide attempts. Psychiatric ADRs accounted for a substantial portion of total reported ADRs for the studied antidepressants, ranging from 33.9% to 38.2%. Venlafaxine had the highest count of psychiatric ADRs (13,134 cases), with duloxetine showing the highest relative percentage (38.2%). Completed suicides were most frequent with venlafaxine (1635 cases), while the highest percentage relative to total ADRs was observed for fluoxetine and citalopram (6%). ADRs occurred more frequently in women, particularly for duloxetine (67%) and sertraline (61.3%), and suicide attempts were prevalent in patients aged 18-64, with notable incidence in the 0-17 age group. This study highlights the significant patterns, risks, and underreporting of psychiatric ADRs associated with commonly prescribed antidepressants. Using EudraVigilance data and a worst-case scenario approach, it reveals the extent of suicide-related ADRs, age and gender disparities, and the impact of incomplete reporting on risk assessment.
选择性5-羟色胺再摄取抑制剂（SSRIs）和5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRIs）等抗抑郁药被广泛使用；然而，人们对精神科药物不良反应（ADR），尤其是自杀观念、自杀未遂和自杀身亡深感担忧。本研究分析了欧洲药物警戒数据库（EudraVigilance）中的药物警戒（PhV）数据，以评估与六种常用抗抑郁药相关的精神科ADR（包括与自杀相关的事件）的发生频率。该研究的另一个目的是评估药物警戒数据在洞察药物相关的实际风险方面的效用，强调改进ADR报告系统以及确保ADR报告的完整性和可靠性的重要性。对度洛西汀、西酞普兰、艾司西酞普兰、氟西汀、文拉法辛和舍曲林2001年12月至2024年9月的数据进行了分析。报告按年龄、性别和来源分类，重点关注精神科ADR和与自杀相关的事件，包括自杀身亡和自杀未遂。精神科ADR在所研究的抗抑郁药报告的ADR总数中占很大比例，范围从33.9%到38.2%。文拉法辛的精神科ADR数量最多（13,134例），度洛西汀的相对百分比最高（38.2%）。自杀身亡在文拉法辛使用者中最为常见（1635例），而相对于ADR总数而言，氟西汀和西酞普兰的百分比最高（6%）。ADR在女性中更频繁发生，尤其是度洛西汀（67%）和舍曲林（61.3%），自杀未遂在18-64岁患者中很普遍，在0-17岁年龄组中发生率也较高。本研究突出了与常用抗抑郁药相关的精神科ADR的显著模式、风险及报告不足的情况。通过使用欧洲药物警戒数据库数据和最坏情况分析方法，该研究揭示了与自杀相关的ADR的程度、年龄和性别差异，以及报告不完整对风险评估的影响。
