Navigation Links
Danger From Heart Surgery Drug Confirmed
Date:5/14/2008

Data on increased death risk should permanently end use of Trasylol, experts say

WEDNESDAY, May 14 (HealthDay News) -- A new Canadian study confirms that people given Trasylol, a drug used to reduce bleeding during heart surgery, increases their risk of death by 53 percent.

Trasylol's German maker, Bayer AG, suspended marketing in the United States last November after preliminary results from this trial revealed problems with the medication.

"In the trial, we asked whether apportioning [Trasylol] was more effective at reducing massive bleeding during high-risk heart surgery compared to other drugs," lead investigator Dr. Dean A. Fergusson, from the University of Ottawa Centre for Transfusion Research, said during a teleconference Monday.

"We also asked were serious complications, such as death and organ failure, lower for aprotinin compared to the two other drugs," Fergusson said.

The report was published in the May 13 online issue of the New England Journal of Medicine.

In the Canadian trial, known as BART, Trasylol was compared with two similar drugs Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid).

During the trial, 2,331 high-risk cardiac patients undergoing heart surgery were randomly assigned to one of the three drugs.

"The most important outcome of the trial was a bit of surprise," co-principal investigator Dr. Paul C. Hebert, a critical care physician at Ottawa Hospital, said during Monday's teleconference.

The rate of death from Trasylol was 6 percent versus 3.9 percent and 4 percent for the other two drugs, Hebert said. "This represents a 53 percent of relative risk of dying, which translates into for every 50 patients treated with apportioning, one patient would die," he said.

Most of the deaths associated with Trasylol were from cardiac complications, Hebert said. Because of the significant increased risk of death, the trial was stopped in October 2007, before the scheduled completion date.

The researchers concluded that while Trasylol may have a small advantage in reducing massive bleeding, the increased risk of death precluded the use of the drug in patients undergoing high-risk heart surgery. "That's the statement at the end of the paper, and we stick by it," Hebert said.

However, despite the drug being pulled off the market in many countries, Bayer continues to sell Trasylol in some areas of the world.

"Trasylol, currently under temporary market suspension worldwide, continues to be available in some countries under special access programs as reviewed and agreed to with the relevant regulatory bodies in those markets," said Bayer spokeswoman Staci Gouveia.

Gouveia noted that Bayer is continuing to keep its options open as to whether it will try to reintroduce the drug.

"Bayer will continue to carefully review this article, the editorial and [when available] the underlying data on which the authors have based their conclusions and continue to discuss both the restricted access programs for Trasylol and the worldwide temporary marketing suspension of the drug with regulatory authorities," Gouveia said.

But one expert thinks the results of this trial end the use of Trasylol during cardiac surgery.

"For all practical purposes, unless there is surprising new data, the BART findings preclude future use of aprotinin in cardiac surgery, even though we don't fully understand why the increased risk of death occurs," said Wayne A. Ray, director of the Division of Pharmacoepidemiology at Vanderbilt University School of Medicine and author of an accompanying journal editorial.

Ray noted that the results of this trial were different from those of other trials, which found no increased risk of death.

"However, this was because the earlier trials were mostly small and not designed to study death," Ray said. "Future studies of drugs to prevent blood loss in cardiac surgery must be designed to look at death and other important clinical consequences, rather than only focusing on blood loss."

Another expert thinks the study starkly shows the dangers of Trasylol.

"This is yet another striking demonstration of the risk of aprotinin," said Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine.

Trasylol had been on the market since 1987 and was widely used.

The big questions remaining are "why it takes so long for the truth to come out? And how many patients were lost because of this misadventure in therapeutics?" Topol said.

Topol thinks there is enough blame to go around. "Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?" he asked.

The U.S. Food and Drug Administration is also very high on the blame list, Topol said. "The FDA has to be considered part of the problem," he said. "Why weren't trials like this part of the early approval process, rather than getting the data many years later?"

More information

For more on heart bypass surgery, visit the U.S. National Library of Medicine.



SOURCES: May 12, 2008, teleconference with Dean A. Fergusson, University of Ottawa Centre for Transfusion Research, Canada; Paul C. Hebert, M.D., critical care physician, Ottawa Hospital, Canada; Wayne A. Ray, Ph.D., director, Division of Pharmacoepidemiology, and professor, preventive medicine, Vanderbilt University School of Medicine, Nashville, Tenn.; Eric J. Topol, M.D., director, Scripps Translational Science Institute, and dean, Scripps School of Medicine, La Jolla, Calif.; Staci Gouveia, spokeswoman, Bayer HealthCare, Tarrytown, N.Y.; May 13, 2008, New England Journal of Medicine, online


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Dr. Arnold Klein Warns of Dangers With Permanent and Longer Lasting Injectable Fillers
2. Mothers Pass Dangerous Toxins to Babies Through Breast Milk
3. Psoriasis Poses Danger for More Serious Complications
4. American Lung Association Applauds Energy and Commerce Committee for its Strong Commitment to Protecting Public Health From the Dangers of Tobacco
5. Lung transplants not dangerous for children with cystic fibrosis, after all
6. How dangerous is boxing for the brain?
7. Fort Dodges Mosquito Shot Offers Convenient Protection Against Dangerous Mosquito-Borne Illnesses
8. The price paid for higher energy is highly dangerous to teeth
9. LightAir Cleans the Air From the Smallest and Most Dangerous Particles Without Generating Ozone
10. Poor sleep more dangerous for women
11. New Drug for Brain Cancer Too Dangerous for Pediatric Patients
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Danger From Heart Surgery Drug Confirmed
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... Those ... deal with these feelings, many turn to unhealthy avenues, such as drug or alcohol ... of Marne, Michigan, has released tools for healthy coping following a traumatic event. , ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Dr. Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile ... orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with ... Latin America . ... ... ... ...
(Date:6/23/2016)... 23, 2016  Experian Health, the healthcare ... the patient payment and care experience, today ... products and services that will enhance the ... offerings. These award-winning solutions will enable healthcare ... compliant in an ever-changing environment and redefine ...
Breaking Medicine Technology: