We read with interest the recent systematic review by Schaub et al.1 about the use of low-dose droperidol for the prevention of postoperative nausea in adults. We agree with their findings regarding the efficacy of low doses of droperidol as prophylaxis against nausea.
In their introduction, the authors state: ‘In 2007, despite the FDA warning, an international consensus panel still recommended intravenous droperidol 0.625 and 1.25 mg as a first-line antiemetic, alone or in combination with other antiemetic drugs, for the prevention of postoperative nausea and vomiting (PONV)’, referencing the consensus guidelines by the Society of Ambulatory Anesthesia (SAMBA).2
In response to concerns about cardiac dysrhythmias resulting from QT prolongation, the Food and Drugs Administration (FDA) added the so-called ‘black-box’ warning to the package insert for droperidol in 2001, stating: ‘…Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with droperidol. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, droperidol should NOT be administered. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2–3 h after completing treatment to monitor for arrhythmias…’.
Following this ‘black-box’ warning, use of droperidol in North America declined significantly.3 Even though the FDA indicated that it had not received data to support or dispute the speculation that lower, unapproved doses (i.e. doses below 2.5 mg) might be sufficiently cardiotoxic so as to merit an equal level of concern,4 the study by White et al.5 showed that up to 5% of patients receiving such lower, unapproved doses of droperidol (0.625 and 1.25 mg), had indeed significant prolongation of their QT interval. After critically evaluating the current medical literature, the expert panel of the SAMBA recommended in 2007 that ‘…if it were not for the black-box warning, droperidol would have been the panel's overwhelming first choice for PONV prophylaxis…’.2
We thank Dr Schaub et al.1 for the work; however, we would like to clarify that the expert panel of the SAMBA does not consider intravenous droperidol 0.625 and 1.25 mg as a first-line antiemetic, alone or in combination with other antiemetic drugs, for the prevention of postoperative nausea and vomiting.
Assistance with letter: none declared.
Financial support and sponsorship: none declared.
Conflicts of interest: none declared.
1. Schaub I, Lysakowski C, Elia N, Tramèr MR. Low-dose droperidol (≤1mg or ≤15mg/kg−1
) for the prevention of postoperative nausea and vomiting in adults: quantitative systematic review of randomised controlled trials. Eur J Anaesthesiol
2. Gan TJ, Meyer TA, Apfel CC, et al. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg
3. Nuttall GA, Eckerman KM, Jacob KA, et al. Does low-dose droperidol administration increase the risk of drug-induced QT prolongation and torsade de pointes in the general surgical population? Anesthesiology
4. Rappaport BA. FDA response to droperidol black box warning editorials. Anesth Analg
5. White PF, Song D, Abrao J, et al. Effect of low-dose droperidol on the QT interval during and after general anesthesia: a placebo-controlled study. Anesthesiology