Evidence-based review of the black-box warning for droperidol.

PURPOSE: Data collected from the Food and Drug Administration (FDA) under the Freedom of Information Act are presented to help clinicians understand the data prompting the black-box warning for droperidol and to make educated decisions regarding the use of droperidol and alternative agents.

SUMMARY: A written request was submitted to FDA to provide a report of any and all reports of cardiovascular adverse events related to droperidol that were part of the decision to add a black-box warning to the label of droperidol. The report listed 277 cases of adverse effects associated with droperidol since its introduction to the market in 1970. Many of the reports were duplicates, leaving a total of 65 individual cases. Of these cases, only 2 described adverse effects possibly caused by droperidol in dosages commonly used in the United States. In addition to these reports, the results of two European studies prompted FDA to make the decision for the black-box warning. Both studies used droperidol doses 50-100 times higher than those used in the United States.

CONCLUSION

Studies show that there is a dose-dependent increase in the rate of adverse cardiovascular events when droperidol is used either alone or in combination with other medications that cause Q-T interval prolongation. At this time, there does not appear to be significant evidence to suggest that serotonin type 3-receptor (5-HT(3)) antagonists are safer than droperidol with regard to Q-T interval prolongation. More studies are needed to determine the safety and efficacy of droperidol when used in doses of 0.625-1.25 mg compared with the 5-HT(3) antagonists.