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Mayo Clinic study finds FDA warning against antinausea drug droperidol unnecessary
Date:9/28/2007

ROCHESTER, Minn. -- A Mayo Clinic review of patients responses to a drug used to control nausea and vomiting during anesthesia for general surgery questions a U.S. Food and Drug Administration (FDA) warning against the drugs use. This study appears in the current issue of the journal Anesthesiology.

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 patients 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.

In our study, we obtained results that were just the opposite of what the FDA action would predict. We actually had fewer complications with droperidol, explains Gregory Nuttall, M.D., the lead Mayo Clinic anesthesiologist on the study. In our experience, low-doses of droperidol used by a skilled team are the safer and more effective agent for controlling nausea and vomiting, which is why we are making plans to resume its low-dose use in select patients in the cardiac Intensive Care Unit.

Significance of the Mayo Clinic Study

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 stronges
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Contact: Amy Tieder
newsbureau@mayo.edu
507-284-5005
Mayo Clinic
Source:Eurekalert

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