Droperidol: should the black box be light gray?
In December 2001, the United States Food and Drug Administration (FDA) added a "black box" warning to the labeling for droperidol stating that all doses, even those typically used for postoperative nausea and vomiting, were potentially associated with malignant ventricular dysrhythmias, including torsade de pointes. The 19 cases in which droperidol doses less than 10 mg were allegedly associated with such dysrhythmias are reviewed in detail. Confounding issues present in a majority of the cases make it difficult to incriminate droperidol as the likely cause of the reported adverse events.
Dershwitz
Mark
M
Department of Anesthesiology, University of Massachusetts Medical School, Worcester, MA 01655, USA. mark.dershwitz@umassmed.edu
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000009:adverse effects* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004329:Droperidol / Q000009:adverse effects* / Q000627:therapeutic use; D004347:Drug Interactions; D004348:Drug Labeling; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control; D015656:Respiratory Mechanics / Q000187:drug effects; D014481:United States; D014486:United States Food and Drug Administration
D000932:Antiemetics; D004329:Droperidol