The US Food and Drug Administration (FDA) has strengthened the warnings and precautions section in the labeling for droperidol, a tranquilizer most often used as a premedication for anesthesia, as a 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 most serious warning for an FDA-approved drug. The new warning is intended to increase a physician's focus on the potential for cardiac arrhythmias during drug administration and to suggest consideration of alternative medications for patients at high risk for cardiac arrhythmias.
Droperidol currently carries a warning about cases of sudden death at high doses (ie, greater than 25 mg) in patients at risk for cardiac arrhythmias. Recent research has shown QT prolongation (ie, delayed recharging of the heart between beats) within minutes after injection of a dose of droperidol at the upper end of the labeled dose range. Prolonged QT is dangerous because it can cause a potentially fatal heart arrhythmia known as torsades de pointes (TdP). In the past year, there have been reports of TdP within or below the currently labeled dose range. There also have been reports of sudden death or other serious cardiac adverse events. The FDA will continue to monitor the postmarketing safety data for droperidol to determine if further action is needed.
FDA Strengthens Warnings for Droperidol (FDA Talk Paper, Rockville, Md: US Food and Drug Administration, Dec 5, 2001) http://www.fda.gov/bbs/topics/ANSWERS/2001/ ANS01123.html (accessed 9 Jan 2002).
COPYRIGHT 2002 Association of Operating Room Nurses, Inc.
COPYRIGHT 2002 Gale Group
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