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

t scientific evidence to date for the performance of droperidol and alternatives.

Background

Since the FDA warning about droperidol was issued in 2001, reports in medical literature have questioned its accuracy and usefulness. It has been well established that all drugs used to prevent or control nausea prior to anesthesia use in general surgery also can have the negative side effect of prolonging a particular kind of abnormal heart rhythm known as long QT. Practitioners didnt understand why just one drug was singled out for a warning.

Dr. Nuttall explains: There is a basic question: Is droperidol really that bad when compared to all the other drugs" I worked with droperidol, and I never saw a problem at the low doses we are talking about. After the warning, we all went to the more expensive drugs. Then we encountered the problem that none address rescue therapy well that means once youre sick, you're stuck; the drugs don't work well. In addition, the data upon with the FDA based its decision came from case reports. Statistically, these are not as strong as controlled, systematic reviews of a large number of patient experiences at a single medical center using the same protocols.

Implications for Patient Care

The Mayo Clinic team hopes another large controlled study will determine if the Mayo results can be validated. If they are validated, it might then prompt the FDA to revoke the warning against droperidol.

In the meantime, Dr. Nuttall recommends that each institution approach low-dose droperidol use with caution in a heart-monitored setting and only with advice from highly trained and experienced anesthesiologists. Our only interest here is in seeing that patients get the safest and most beneficial treatment, Dr. Nuttall says.


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

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