Navigation Links
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 strongest 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.


'/>"/>

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

Related medicine news :

1. Scientists plan human cloning clinic in the United States
2. How do patients benefit of clinical trials
3. Magnetic resonance angiography in clinical medicine
4. Clinical trials need to be more frank
5. AEternas acquisition of Zentaris being followed up with its new product pipeline and clinical development strategy
6. Physicians Lack Clinical Guidelines For Treating Elderly With Multiple Illnesses
7. The Growing Rise In Clinical Research Could Lead To A Compromise In Quality Of Research And Ethics
8. Clinical Comparisons Between ADHD Drugs Are Less
9. Specialized Clinics For Manipurs AIDS Patients
10. Outsourcing clinical trials to India
11. Erectile dysfunction: an early warning sign of clinically silent coronary artery disease?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... , ... Center for Autism and Related Disorders (CARD) Portland today announced plans ... (ASD) and other developmental disabilities. The group, which is being launched with the help ... opportunity to share stories and advice, seek help, and continue their education on how ...
(Date:12/2/2016)... PA (PRWEB) , ... December 02, 2016 , ... With ... struggling through rehabilitation of an injury, patients must find the one that works for ... his pain, he created a machine that worked and decided to share it with ...
(Date:12/2/2016)... ... December 02, 2016 , ... More than half of American teens report ... parents report speaking with their child about sex related topics, less than 60 percent ... is proud to announce the launch of its second edition of the “Sexual Wellness” ...
(Date:12/2/2016)... ... 02, 2016 , ... The PAINWeekEnd Regional Conference will be ... in Honolulu, offering local frontline clinicians the opportunity to extend their certified continuing ... for supplemental training related to pain management has surged dramatically in recent years, ...
(Date:12/2/2016)... ... December 02, 2016 , ... Rijuven Corp launches rejiva ( http://www.rejiva.com ), ... night. No other wearable health technology on the market can deliver all that rejiva ... more meaningful insights about their health than the usual heart rate and steps taken”, ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... , December 2, 2016 bioLytical Laboratories, ein Weltführer ... bei den Mitgliedern des Apothekenbundes von Kenia eingeführt. ... ... INSTI HIV Self Test! (PRNewsFoto/bioLytical Laboratories) ...      (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) ...
(Date:12/2/2016)... , Dec. 2, 2016   CytoSorbents Corporation ... commercializing its European Union approved CytoSorb ® cytokine ... surgery patients worldwide, announced that Dr. Phillip Chan ... 9th Annual LD Micro Main Event investor conference ... at the Luxe Sunset Boulevard Hotel in ...
(Date:12/2/2016)... 1, 2016  Today, Simpson Healthcare Executives, a global ... being selected as winners of multiple awards at the ... at the PLATINUM level, Blue Zones Menu at the ... GOLD Level, and our proprietary 3ConneX Platform at the ... Executives, we are excited to showcase our new Platinum ...
Breaking Medicine Technology: