Greenwich Hospital, Greenwich, Connecticut, USA
Curr Opin Anaesthesiol. 2010 Jun;23(3):423-7. doi: 10.1097/aco.0b013e328338c9f7.
To evaluate the United States Food and Drug Administration use of the black-box warning system to promote drug safety and to examine the droperidol black-box warning as a case study.
Scientific studies report that there is no basis to issue a black-box warning for perioperative administration of droperidol for postoperative nausea and vomiting on the basis of the potential of adverse cardiac events (prolongation of the QT interval and/or development of torsades de pointes).
Rather than relying on well conducted clinical investigations, the Food and Drug Administration subjectively issued a black-box warning to droperidol, which effectively removed droperidol from clinical practice for the indication of postoperative nausea and vomiting. Newer data suggest that the incidence of prolongation of the QT interval and the occurrence of torsades de pointes is similar to more expensive alternative medications used to treat postoperative nausea and vomiting.
评估美国食品和药物管理局（FDA）使用黑框警告系统以促进药物安全，并将氟哌利多黑框警告作为一个案例研究。
科学研究报告称，在潜在的不良心脏事件（QT 间期延长和/或尖端扭转型室性心动过速的发生）的基础上，为预防术后恶心和呕吐而给予氟哌利多的围手术期使用并无依据，因此不应发出黑框警告。
FDA 并未依据精心设计的临床研究，而是主观地对氟哌利多发出黑框警告，这有效地将氟哌利多从治疗术后恶心和呕吐的适应证中撤出。新的数据表明，QT 间期延长的发生率和尖端扭转型室性心动过速的发生与用于治疗术后恶心和呕吐的更昂贵的替代药物相似。
