Institute for Medical Biometry, Informatics and Epidemiology, University Hospital of Bonn, Bonn, Germany.
Federal Institute for Drugs and Medical Devices (BfArM), Research Division, North Rhine-Westphalia, Bonn, Germany.
BMC Pharmacol Toxicol. 2023 Mar 31;24(1):22. doi: 10.1186/s40360-023-00664-z.
Since the warnings by the United States (US) and European regulatory authorities in 2004 and 2005 it had been discussed whether there is some link between selective serotonin reuptake inhibitors (SSRIs) and suicidality in the pediatric population. The aim of our study was to describe trends and patterns in spontaneous reporting data referring to suicidality in children, adolescents and young adults treated with SSRI after the warnings.
Descriptive analyses of reports for 0-24 year olds referring to suicide/suicidal ideations, self-harms and overdoses with SSRIs reported as suspected submitted to the US (FAERS) and the European (EudraVigilance) adverse drug reaction databases until 2019 were performed. The causal relationship was assessed in accordance with the WHO criteria for the European reports. For Germany, prescription data for SSRIs were provided and reporting rates (number of reports/number of prescriptions) were calculated for the reports with possible causal relationship (so called "confirmed reports").
Since 2004, the number of reports referring to suicide/suicidal ideations, self-harm and overdoses increased steadily in the US and EU. However, only a slight increase was seen for the confirmed EU reports. After 2008, the proportion of reports informing about suicidal ideations increased, while the proportion of fatal suicide attempts decreased. Reporting rates were higher for females and adolescents (12-18 years).
Our results demonstrate the importance of further monitoring suicidality in 0-24 year olds treated with SSRI in order to recognize suicidality early avoiding fatal suicide attempts. The higher reporting rates for females and adolescents should be further investigated.
自 2004 年和 2005 年美国和欧洲监管机构发出警告以来，人们一直在讨论选择性 5-羟色胺再摄取抑制剂（SSRIs）与儿科人群自杀之间是否存在某种联系。我们的研究目的是描述在发出警告后，接受 SSRIs 治疗的儿童、青少年和年轻成年人中与自杀相关的自发报告数据的趋势和模式。
对美国（FAERS）和欧洲（EudraVigilance）药物不良反应数据库中报告的 0-24 岁儿童、青少年和年轻成年人使用 SSRIs 后报告的自杀/自杀意念、自残和过量的报告进行描述性分析。根据世界卫生组织（WHO）对欧洲报告的因果关系评估标准评估因果关系。对于德国，提供了 SSRIs 的处方数据，并计算了可能存在因果关系的报告（所谓的“确认报告”）的报告率（报告数量/处方数量）。
自 2004 年以来，美国和欧盟报告自杀/自杀意念、自残和过量的报告数量稳步增加。然而，在确认的欧盟报告中，只看到了轻微的增加。自 2008 年以来，报告自杀意念的报告比例增加，而致命自杀企图的比例下降。女性和青少年（12-18 岁）的报告率较高。
我们的结果表明，需要进一步监测接受 SSRIs 治疗的 0-24 岁儿童和青少年的自杀情况，以便及早识别自杀倾向，避免致命自杀企图。应进一步调查女性和青少年报告率较高的原因。
