(Circulation. 2001;104:e9061.)
© 2001 American Heart Association, Inc.
Cardiovascular News
Circulation Newswriter
Warnings Strengthened on Tranquilizer Inapsine (Droperidol)
On December 7, 2001, the US Food and Drug Administration and Akom Pharmaceuticals strengthened warnings on the tranquilizer Inapsine (droperidol) in the wake of reports of QT prolongation and/or torsades de pointes at doses equal to or below those that are recommended. In some instances, patients who suffered these effects had no known risk factors for QT prolongation. According to information from the FDA, the effects have been fatal in some cases.
In an explanatory talk paper issued for the public by the FDA (available at http://www.fda.gov/bbs/topics/ ANSWERS/2001/ANS01123.html), the agency said droperidol is most often used as a premedication for anesthesia, a treatment for nausea after anesthesia, and a sedative for agitated patients. "Droperidol has been associated with fatal cardiac arrhythmias." In its changes to the drug’s labeling, the federal agency has included a ‘black box’ warning, the most serious alert for a drug that has been approved by the FDA. In this case, the FDA paper stated, "The new warning is intended to increase the physician’s focus on the potential for cardiac arrhythmias during drug administration, and to consider the use of alternative medications for patients at high risk for cardiac arrhythmias.
Before the shift in the warning, the drug carried a statement indicating that there had been cases of sudden death at doses above 25 mg in patients known to be at risk for abnormal heart rhythms. According to the FDA talk paper, "Recent research has shown QT prolongation (delayed recharging of the heart between beats) within minutes