Navigation Links
Danger From Heart Surgery Drug Confirmed

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:
Related Image:
Danger From Heart Surgery Drug Confirmed
(Date:10/9/2015)... Francisco, CA (PRWEB) , ... October 09, 2015 ... ... Geneva, Switzerland for highly sought after internships at the pre-eminent organization in global ... movement dedicated to eliminating social and health disparities. These internships are a mechanism ...
(Date:10/9/2015)... ... ... "My spouse and I rely on canes to walk, and we both have ... Buffalo, N.Y. "This is not only frustrating but it’s unsanitary. My design solves this ... to keep a cane upright while it’s not in use. It prevents the cane ...
(Date:10/9/2015)... ... ... Head Over Heels Athletic Arts gymnast, Madelyn Williams, will attend the USA ... Huntsville, Texas on October 17-21. , "It's very exciting to be invited to ... director, said. “It's a stepping stone into the U.S. elite system where Maddie and ...
(Date:10/9/2015)... ... October 09, 2015 , ... Confidence Plus Insurance ... a community improvement initiative that involves working with a series of local charities ... of Confidence Plus Insurance is the Gleason Park Electric Violin Ensemble (GPEVE). , ...
(Date:10/9/2015)... ... October 09, 2015 , ... MMJ PhytoTech Limited ... Ed Begley Jr., airing 1st QT 2016 via the Discovery Channel. Dates and ... Phytotech Limited (MMJ) – a global leader in the field of commercializing medicinal ...
Breaking Medicine News(10 mins):
... News) -- Crohn,s disease may cause post-traumatic stress disorder ... nearly 600 Swiss adults with Crohn,s disease, an incurable ... The study participants underwent PTSD assessment at the ... were found to have the disorder. All the participants ...
... News) -- A U.S. Food and Drug Administration advisory committee ... prevention of prostate cancer, the third-highest cancer killer of men. ... the risks of Merck,s Proscar outweighed its benefits, according to ... the panel voted 14-2, with two abstentions, against GlaxoSmithKline,s Avodart. ...
... veterans are nearly three times as likely as civilians ... researchers at Portland State University (PSU) and Oregon Health ... Deaths Among Women With U.S. Military Service: A Hidden ... Psychiatric Services , a journal published by the American ...
... HealthDay Reporter , WEDNESDAY, Dec. 1 (HealthDay News) -- The ... from CT scans may be lower than previously thought, new ... Wednesday at the annual meeting of the Radiological Society of ... of Medicare records covering nearly 11 million patients. , "What ...
... , WEDNESDAY, Dec. 1 (HealthDay News) -- The case of ... colitis -- and actually got better -- sheds light on ... study suggests. "Our findings in this case report suggest ... roundworm can alleviate the symptoms of ulcerative colitis," said ...
... Medicine (BUSM) have identified a mechanism by which specific viruses ... This finding, which is currently featured in an online edition ... to the development of more targeted treatments against many types ... Dunn, a postdoctoral fellow, under the direction of John H. ...
Cached Medicine News:
(Date:10/9/2015)... CINCINNATI , Oct. 9, 2015  Xavier ... Thinking labs with Konica Minolta Medical Imaging (KMMI) on ... utilize Design Thinking to help healthcare providers imagine and ... a visual roadmap that they can customize for their ... Primary Imaging is the initial procedure, or study, in ...
(Date:10/9/2015)... 2015 ® ) ... Kolonoskopie im Rahmen eines Screenings, einer beobachtenden ... bewertete auch die Compliance, Sicherheit, Patientenakzeptanz und ... ) an erwachsenen Patienten vergleicht, die sich ... beobachtenden oder einer diagnostischen Kolonoskopie unterziehen. Die ...
(Date:10/9/2015)... BETHESDA, Maryland , October 9, 2015 ... Pharmaceuticals Inc. (OTCQB: CNBX) has announced its execution of ... Debt & Liabilities Agreement with Cannabics, Inc. a Delaware Corporation, ... the company. --> --> ... internal restructuring of the Company, whereby the Research and ...
Breaking Medicine Technology:
... 2011 Hospira, Inc. (NYSE: HSP ), a ... that the company will present at the Sanford C. Bernstein ... in New York. The presentation is scheduled to ... 2011.  It will be available to all interested parties through ...
... May 12, 2011 Men and women infected with ... their sexual partners through initiation of oral antiretroviral therapy ... study conducted by the HIV Prevention Trials Network (HPTN), ... HIV through cutting-edge biomedical, behavioral, and structural interventions. ...
Cached Medicine Technology:
... Tri-Flo® suction catheter design was created ... patients while still providing high suctioning ... (5/6, 8 or 10 Fr) feature ... catheter placement. Our complete catheter line ...
Tracheal Suction Latex Rubber Catheters - Funnel End...
Rubber bronchial coude catheter, X-ray opaque, one eye, whistle tip....
KCIs KinAir IV combines Advanced Pressure Relief Therapy with a manual wound care turn to provide optimum skin care and patient,positioning....
Medicine Products: