More recently, the US Food and Drug Administration (FDA) applied a ”black box” warning to all antidepressant drugs labelling, but fell short of restricting the use of any individual drug. This was done after an FDA commissioned re-analysis of safety data from all trials of the newer antidepressants demonstrated increased risk of suicidality (definitive suicidal behaviour/ ideation) and increased risk of treatment-emergent hostility or agitation in those treated with the active drug compared to placebo.
前不久，美国食品药物管理局(FDA)在所有的抗抑郁类药品标签上添加“黑框”警告，但却无法限制于个人使用此类药品。在此之前，FDA授权对一些新抗抑郁类药品试验的安全数据进行再分析，结果发现这些药品与安慰剂相比，能造成更高的自杀性（确定的自杀行为/倾向）风险和更强烈的紧急治疗敌对情绪或兴奋感。