The FDA warning against droperidol was prompted in 2001 over concerns that the drug contributed to potentially fatal heart rhythm abnormalities. Mayo Clinic compared 139,932 patientsâ€™ responses before the warning was issued (and droperidol was used) and found no proven cases of complications directly attributable to droperidol. In comparison, after the FDA warning, two of 151,256 patients had poor heart rhythm while receiving other, more expensive medication alternatives. The percentage of patients who received droperidol was 12 percent prior to the warning and 0 percent after placement of the warning.
Based on their findings, Mayo Clinic anesthesiologists conclude that the FDA warning against droperidol is unnecessary. They call for other investigators to study the topic to determine if further inquiry supports that conclusion.
The Mayo Clinic study is the first large, statistically well-controlled study of patient responses to droperidol at a single medical center over a long time (three years) that included treatment before and after the FDA warning. As such, it provides the strongest scientific evidence to date for the performance of droperidol and alternatives.