Pro: The Food and Drug Administration Black box warning on droperidol is not justified.

摘要

Droperidol is a cost-effective antiemetic that has been used extensively in anesthetic practice. IV doses of 0.625-1.25 mg have been recommended as first-line therapy for the prophylaxis of postoperative nausea and vomiting (PONV).1'2 However, in December 2001, the United States Food and Drug Administration (FDA) issued a new black box warning due to the potential for serious proarrhythmic effects, and even death, after the administration of droperidol. The FDA noted that cases of QT prolongation and/or torsades de pointes (TdP) were reported, even when doses less than the 2,5 mg labeled dose of droperidol were used. The warning was based on 273 cases reported over a 4-yr period. A possible cardiac event occurred in 74 cases. There were 89 deaths reported, but the dose of droperidol was 2 5 mg or less in only two deaths. The majority of deaths involved droperidol doses that ranged from 25 to 250 mg Five patients receiving droperidol 2,5 mg or less experienced either ventricular tachycardia or TdP.3 Furthermore, of all the cases reported, cardiac adverse events or death occurred in 10 patients when the recommended 0.625-1.25 mg antiemetic doses of droperidol were used. Careful review of those cases did not reveal evidence of a cause-and-effect relationship.