News Briefs: FDA issues stronger warnings for droperidol
The Food and Drug Administration (FDA) has strengthened the warnings and precautions sections in the labeling for droperidol, a tranquilizer used most often as a premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients. Droperidol has been associated with fatal cardiac arrhythmias.
Specific changes to the droperidol labeling include a "black box" warning. The new warning is intended to increase the physician’s focus on the potential for cardiac arrhythmias during drug administration, and to encourage the use of alternative medications for patients at high risk for cardiac arrhythmias.
Droperidol currently carries a warning about cases of sudden death at high doses (greater than 25 mg) in patients at risk for cardiac arrhythmias. Recent research has shown QT prolongation within minutes after injection of a dose of droperidol at the upper end of the labeled dose range.
In the past year, there have been reports of torsades de pointes (TdP) within or below the currently labeled dose range. There also have been reports of sudden death or other serious cardiac adverse events.
Manufacturer Akorn Pharmaceuticals of Buffalo Grove, IL, is sending a "Dear Healthcare Professional" letter to physicians, pharmacists, and other health care professionals in the United States. The letter explains the "black box" warnings and highlights the potential for QT prolongation or TdP when this drug is administered.
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