Sedation ======== þ Droperidol - per ACEP News, August 2002 "FDA STRENGTHENS WARNINGS FOR DROPERIDOL" (which is very critical of the FDA's black box warning, and includes information that ACEP believes droperidol OK without a 12-lead EKG), Ondansetron is not better than other, cheaper drugs, and the literature supporting is is very weak, and uses duplicate publication and other sleazy methods to show its effectiveness. References from above article: 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 most serious warning for a FDA-approved drug. The new warning is intended to increase the physician's focus on the potential for cardiac arrhythmias during drug administration, and to consider 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 (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 last year, there have been reports of TdP within or below the currently labeled dose range. There have also been reports of sudden death or other serious cardiac adverse events. FDA will continue to monitor the postmarketing safety data for droperidol to determine if further action is needed. The manufacturer, Akorn Pharmaceuticals, is sending a "Dear Healthcare Professional" letter to physicians, pharmacists, and other healthcare professionals in the U.S. The letter explains the black box warnings and highlights the potential for QT prolongation or torsades when this drug is administered. For more information, patients and healthcare providers can call Akorn Pharmaceuticals at 1-888-519-8384 Note from Art Hayes by email, 2/2/02: Droperidol is rather a knee jerk reaction. In literally millions of uses, there are less than 100 reported cases with 8 deaths, all from high dose droperidol, secondary to Q-T prolongation. The Q-T prolongation is dose dependent, and has not been seen in the low starting doses we use. I also use ibutilide in the ED which is approved even though it has a 2% rate of Torsades/V-tach. Granted we do it in a setting where we expect it, but the hospital is considering taking Droperidol off formulary for inpatient use. Very reactionary. There is science plus experience which suggests this is not unsafe! I vote we keep it!