Stephen B. Soumerai (
Ross Koppel, University of Pennsylvania, Philadelphia, Pennsylvania; and University at Buffalo, State University of New York, Buffalo, New York.
Health Aff (Millwood). 2024 Oct;43(10):1360-1369. doi: 10.1377/hlthaff.2023.00263.
Since 2003, the Food and Drug Administration (FDA) has warned that antidepressants may be associated with suicidal thoughts and behaviors among youth. An FDA advisory in 2003 and a black-box warning in 2005 focused on children and adolescents younger than age eighteen. The FDA expanded the black-box warning in 2007 to include young adults. Both warnings were intended to increase physician monitoring of suicidal thoughts and behaviors. Our systematic review identified thirty-four studies of depression and suicide-related outcomes after these warnings; eleven of these studies met research design criteria established to reduce biases. The eleven studies examined monitoring for suicidal thoughts and behaviors, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use, and psychotropic drug poisonings (a proxy for suicide attempts) and suicide deaths. We assessed possible spillover to adults not targeted by the warnings. The one study that measured intended physician monitoring of suicidal thoughts and behaviors did not find evidence of an increase. Multiple studies found significant unintended reductions in mental health care after the warnings. After these reductions, there were marked increases in psychotropic drug poisonings and suicide deaths. These findings support reevaluation of risks and benefits of the FDA's black-box antidepressant warnings.
自 2003 年以来，美国食品和药物管理局（FDA）一直警告称，抗抑郁药可能与青少年的自杀念头和行为有关。2003 年的 FDA 咨询意见和 2005 年的黑框警告主要针对 18 岁以下的儿童和青少年。2007 年，FDA 将黑框警告扩大到包括年轻成年人。这两个警告都是为了增加医生对自杀念头和行为的监测。我们的系统评价确定了在这些警告之后与抑郁和自杀相关的结果的 34 项研究；其中 11 项研究符合旨在减少偏倚的研究设计标准。这 11 项研究检查了自杀念头和行为的监测、抑郁症的医生就诊、抑郁症的诊断、心理治疗就诊、抗抑郁药物治疗和使用以及精神药物中毒（自杀企图的替代指标）和自杀死亡情况。我们评估了对未被警告针对的成年人可能产生的溢出效应。唯一一项测量了医生有意监测自杀念头和行为的研究并没有发现增加的证据。多项研究发现，在这些警告之后，心理健康护理出现了显著减少。减少之后，精神药物中毒和自杀死亡的人数显著增加。这些发现支持重新评估 FDA 黑框抗抑郁药警告的风险和益处。
