The use of droperidol before and after the food and drug administration black box warning: a survey of the members of the society of ambulatory anesthesia

J Clin Anesth 2008;20:35-39

Habib AS, Gan TJ

 

 

Abstract

Purpose            The purpose of this study was to survey the members of the Society of Ambulatory Anesthesia (SAMBA) about their practice in the management of postoperative nausea and vomiting (PONV) before and after the FDA black box warning on droperidol usage.

Background            Droperidol is one of the most effective and cost-efficient antiemetics for PONV. In December 2001, the FDA issued a “black box” warning on droperidol because of concerns of serious cardiac arrhythmias secondary to QT prolongation. The warning was based on 273 cases reported over a 4-year period, of which 127 cases resulted in serious adverse outcomes. Adverse cardiac events occurred in a total of 10 cases when the dose of droperidol used was 0.625 to 1.25 mg.

Methodology            After IRB approval, a survey was posted on the SAMBA web site from June 2005, until October 2005. The survey was designed to elicit information about the management of PONV and, in particular, the use of droperidol, before and after the FDA black box warning. The participants were also asked about reasons for not using droperidol in their current practice and whether they believed that the black box warning was justified. Logistic regression analysis was used to assess the association between choice of antiemetics made by the responder and responder’s type of practice, as well as years of experience.

Result            A total of 295 providers completed the survey (25% of SAMBA members). Some 215 of 292 respondents (74%) indicated that droperidol was available in the formulary in their hospital. However, 44 of 292 (15%) indicated that droperidol was not available in their hospital. For prophylaxis, the choice of other antiemetics and combinations not involving droperidol as a first-line agent for PONV prophylaxis was significantly less after the black box warning compared with before the warning. For the treatment of PONV, the choice of droperidol as a first-line agent for the treatment of established PONV was significantly less after the warning, whereas the choice of 5-HT3 receptor antagonists, dexamethasone, and promethazine was significantly higher. For the management of PONV, 42% of providers stated that they no longer used droperidol. Finally, 92% of 284 respondents did not believe that the black box warning on droperidol was justified and 60% indicated that they would use droperidol as their first-line agent for PONV prophylaxis if this warning were to be removed.

Conclusion            The choice of droperidol as a first-line agent for the management of PONV significantly declined after the FDA black box warning. Despite that, 92% of respondents did not believe that the black box warning was justified. There was a 10-fold decrease in droperidol use in the United States after the FDA black box warning. The survey also showed that, at the same time, choice of the more expensive 5-HT3 receptor antagonists significantly increased.

 

Comment

This study surveyed members of an anesthesia community on the use of droperidol after the FDA black box warning. The survey reflected a significant decrease in droperidol use among this community of anesthesia providers after the FDA black box warning of 2001. Ninety-two percent of respondents did not believe that the warning was justified.

 

Joseph F. Burkard, DNSc, CRNA