The US fodder and Drug Administrat...

The US fodder and Drug Administration (FDA) has strengthened the warnings and precautions section in the labeling for droperidol, a tranquilizer mostly 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 mostly serious warning for an FDA-approved mix with drugs The new warning is intended to increase a physician's focus onward the potential for cardiac arrhythmias during mix with drugs administration and to suggest consideration of alternative medications for patients at high risk for cardiac arrhythmias.

Droperidol commonly carries a warning about cases of unexpected death at high doses (ie, greater than 25 mg) in patients at risk for cardiac arrhythmias. newly come 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 period of the labeled dose range. extended 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 publicly labeled dose range. There also have been reports of unlooked for death or other serious cardiac adverse adventures 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 nutriment and Drug Administration, Dec 5 2001) http://www.fda.gov/bbs/topics/ANSWERS/2001/ ANS01123.html (accessed 9 Jan 2002)

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