Evidence-based Review of the Black-box Warning for Droperidol

Cherry W. Jackson; Amy Heck Sheehan; Jennifer G. Reddan

Disclosures

Am J Health Syst Pharm. 2007;64(11):1174-1186. 

In This Article

Summary

Droperidol was a first-line, highly effective agent for the treatment of PONV for over 30 years. It has the most postmarketing surveillance data of any of the currently used antiemetic agents. Yet, despite its history of safety and efficacy at doses of 0.625-1.25 mg, FDA mandated that a black-box warning be added to droperidol's labeling and recommended, based on anecdotal reports, that it not be used as a first-line treatment.

Randomized controlled trials have demonstrated that droperidol is as safe and effective as ondansetron. Droperidol doses of 1.25 mg appear to be more efficacious than 4-mg doses of ondansetron with no difference in adverse effects. Studies have shown a dose-dependent increase in the rate of adverse cardiovascular effects when droperidol is used alone or with other medications that prolong the Q-T interval. At this time, there does not appear to be significant evidence that the 5-HT3 antagonists are safer than droperidol regarding Q-T interval prolongation. Further, they lack a similar number of years of postmarketing surveillance.

FDA has promised to revisit the evidence for droperidol's black-box warning either through an internal study or review of an external study, such as the one completed by White et al.[30] Due to the economic effect of the black-box warning on the treatment of PONV, recommendations coming from a review of this study or an internal study cannot come too soon.

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