Droperidol (Controversies)

Controversy: whether or not droperidol should be used as an antiemetic agent

Data In Favor of Black Box Warning:

FDA black box warning

Review of Documented Cases: Habib et. al.

The FDA warning is based on 10 reported cases from 1997-2002 [Habib et. al. Anesth Analg 96: 1377, 2003] – these 10 cases were all with 1.25 mg or less.

Data in Favor of Droperidol Use:

Review of Documented Cases: Habib et. al.

In none of the 10 cases with 1.25 mg or less could a definitive cause-effect relationship be described, and in five of them there were substantial confounding factors. Assuming that droperidol sales averaged 11 MM ampules per year, and that these events were truly related to droperidol, the authors estimated that the incidence of associated events was 1:150,000 [Habib et. al. Anesth Analg 96: 1377, 2003]

Charbit et. al.

A small study compared QT prolongation with droperidol alone, ondansetron alone, and both combined. Both droperidol and ondansetron significantly prolonged QT interval as expected (droperidol>ondansetron), but when combined did not prolong QT significantly more than droperidol alone [Charbit et. al. Anesthesiology 109: 206, 2008]

Chu et. al.

400 total patients (randomized, prospective, controlled) studied haloperidol plus dexamethasone on PONV versus placebo and droperidol alone in vaginal hysterectomy patients. Haloperidol plus dexamethasone produced the greatest reduction in PONV when compared to placebo, either drug alone, or droperidol alone. There was no difference in QT prolongation in the haloperidol plus dexamethasone vs. droperidol alone [Chu CC et al. Anesth Analg 106: 1402, 2008.

Nuttal et. al.

Lastly, a retrospective study in Anesthesiology studied whether or not droperidol (low dose) administration increased the incidence of torsades during a 3 year period before and after the FDA placed the black box warning on the drug. They determined that there was no change in the incidence of torsades with the use of low dose droperidol versus none used. The incidence of torsades in droperidol exposure was found to be 1:16791, and the one incident may not have actually been due to droperidol [Nuttal et. al. Anesthesiology 107: 531, 2007]