The interest of Dr. Sosis in our recent article1demonstrating the absence of a clinically significant effect of low-dose droperidol on the QT interval after a propofol induction is appreciated. As stated in my earlier editorial,2despite widespread clinical use in anesthesia for more than 30 yr, not a single case report describing a droperidol-induced arrhythmia has appeared in the peer-reviewed anesthesia literature despite the US Food and Drug Administration–imposed “black box” warning (excluding the questionable case report3mentioned by Dr. Sosis, which appeared in a Japanese journal in 2002). Even with extensive use of high-dose droperidol as part of a standard “neurolept” anesthetic technique, there have not been any reported cases of droperidol-induced dysrhythmias during anesthesia.
In considering the facts of this particular case report,3Dr. Sosis neglected to mention that the administered dose of droperidol was more than 10 times the standard antiemetic dosage. Second, the alleged case of droperidol-induced multifocal ventricular dysrhythmias occurred in a woman with chronic renal failure who was receiving hemodialysis. Importantly, there was no mention of her electrolyte status at the time of the acute event. Third, she was given a 10-mg intravenous bolus dose of droperidol during general inhalation anesthesia with a combination of isoflurane and nitrous oxide. This combination of inhaled and intravenous drugs would hardly be described as classic neurolept anesthesia.
I stand by my earlier published statements that there has not been a single documented case of a serious cardiac arrhythmia occurring in a patient receiving an antiemetic dose (e.g. , 0.625–1.25 mg) of droperidol or even a large dose of droperidol (e.g. , 10 mg) as part of a true neurolept anesthetic technique. Hopefully, the decision-makers at the Food and Drug Administration will come to their senses and remove the unwarranted black box warning on this highly cost-effective antiemetic drug.
University of Texas Southwestern Medical Center, Dallas, Texas. email@example.com