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.
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