Droperidol, a sedation drug, is safe an effective to use to calm violent and aggressive patients in the ER even though it garnered a black box warning from the U.S. Food and Drug Administration, according to a study published in the Annals of Emergency Medicine journal.
The FDA issued the black box warning in 2001 because the drug had side effects of causing heart rhythm disorders. Before the black box warning, droperidol was commonly used to treat aggressive or violent emergency patients. Since the black box warning was issued, use of the drug dropped worldwide.
However, researchers found that of the 1,009 patients sedated with the drug, just six had a heart rhythm disorder not attributed to other factors. Adverse events occurred in 5 percent of patients and over sedation happened in 8 percent of patients.
"In our study, the two side effects that led to the black box warning, QT prolongation and torsades des pointes, both heart rhythm disorders, turned out to be rare and non-existent, respectively," said Geoff Isbister, MD, the lead author of the study. "IN addition, almost all patients were sedated within two hours, which of course is the goal with an agitated patient. We did find some adverse effects in patients who were sedated with droperidol in combination with benzodiazepines."
Dr. Isbister concluded, "High-dose droperidol on its own seems to be both safe and effective for patients who are potentially dangerous to themselves and others."