Jackson Cherry W, Sheehan Amy Heck, Reddan Jennifer G
Harrison School of Pharmacy, Auburn University, Auburn, AL 36849-8353, USA.
Am J Health Syst Pharm. 2007 Jun 1;64(11):1174-86. doi: 10.2146/ajhp060505.
Data collected from the Food and Drug Administration (FDA) under the Freedom of Information Act are presented to help clinicians understand the data prompting the black-box warning for droperidol and to make educated decisions regarding the use of droperidol and alternative agents.
A written request was submitted to FDA to provide a report of any and all reports of cardiovascular adverse events related to droperidol that were part of the decision to add a black-box warning to the label of droperidol. The report listed 277 cases of adverse effects associated with droperidol since its introduction to the market in 1970. Many of the reports were duplicates, leaving a total of 65 individual cases. Of these cases, only 2 described adverse effects possibly caused by droperidol in dosages commonly used in the United States. In addition to these reports, the results of two European studies prompted FDA to make the decision for the black-box warning. Both studies used droperidol doses 50-100 times higher than those used in the United States.
Studies show that there is a dose-dependent increase in the rate of adverse cardiovascular events when droperidol is used either alone or in combination with other medications that cause Q-T interval prolongation. At this time, there does not appear to be significant evidence to suggest that serotonin type 3-receptor (5-HT(3)) antagonists are safer than droperidol with regard to Q-T interval prolongation. More studies are needed to determine the safety and efficacy of droperidol when used in doses of 0.625-1.25 mg compared with the 5-HT(3) antagonists.
提交根据《信息自由法案》从美国食品药品监督管理局（FDA）收集的数据，以帮助临床医生理解促使对氟哌利多发出黑框警告的数据，并就是否使用氟哌利多及替代药物做出明智决策。
向FDA提交了书面请求，要求提供任何和所有与氟哌利多相关的心血管不良事件报告，这些报告是决定在氟哌利多标签上添加黑框警告的一部分。该报告列出了自1970年氟哌利多上市以来277例与之相关的不良反应病例。许多报告存在重复，最终共有65例独立病例。在这些病例中，仅有2例描述了可能由美国常用剂量的氟哌利多引起的不良反应。除这些报告外，两项欧洲研究的结果促使FDA做出了发出黑框警告的决定。这两项研究使用的氟哌利多剂量比美国使用的剂量高50 - 100倍。
研究表明，单独使用氟哌利多或与其他导致Q-T间期延长的药物联合使用时，心血管不良事件发生率会随剂量增加而上升。目前，似乎没有充分证据表明5-羟色胺3型受体（5-HT(3)）拮抗剂在Q-T间期延长方面比氟哌利多更安全。与5-HT(3)拮抗剂相比，需要更多研究来确定0.625 - 1.25毫克剂量的氟哌利多的安全性和有效性。
