Navigation Links
Another Study Warns of Risk From Cardiac Surgery Drug
Date:12/2/2008

Patients given Trasylol have a higher death risk, data review finds

TUESDAY, Dec. 2 (HealthDay News) -- A new study casts more doubt on the safety of the drug Trasylol (aprotinin), used to limit bleeding in patients undergoing surgery.

Trasylol is already the subject of controversy in the United States, where it was removed from the market in 2007.

In the new study, Canadian and Australian researchers reviewed findings from 49 randomized clinical trials. They concluded that Trasylol posed a higher risk of death for patients than other anti-bleeding drugs, called lysine analogues.

While Trasylol was somewhat more effective at controlling blood loss and transfusions than lysine analogues, its higher risk of death and significantly higher price are deterrents to its use, said the authors. They recommended tranexamic acid or aminocaproic acid as alternatives to prevent blood loss during surgery.

"Lysine analogues are almost as effective as aprotinin in controlling blood loss, are cheaper, and appear not to increase mortality," concluded Dr. David Henry and his co-authors of the study, which will be published in the Jan. 20 issue of the Canadian Medical Association Journal.

The findings were released early in advance of a Health Canada expert advisory panel meeting scheduled for Wednesday. The panel is expected to make a decision about the use of aprotinin.

The review included new information from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study published by the New England Journal of Medicine earlier this year. That study found that patients treated with aprotinin were 53 percent more likely to die than those treated with two similar drugs, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid). The death rates were 6 percent, 3.9 percent and 4 percent, respectively.

Due to the significant risk of death associated with Trasylol, the BART study was stopped in October 2007, before the schedule completion date.

In November 2007, Trasylol manufacturer Bayer AG suspended the drug's marketing in the United States after the preliminary results from the BART trial were released. Bayer removed all remaining stocks of the drug from the U.S. market earlier this year. However, the German drug maker continues to sell Trasylol in some areas of the world.

Trasylol has been on the market since 1987 and widely used. At the time of the BART study's release, one expert questioned why the truth about the dangers of the drug took so long to come out and how many patients may have died "because of this misadventure in therapeutics?"

"Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?" asked Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine.

The U.S. Food and Drug Administration is high on the blame list, Topol told HealthDay.

"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

The U.S. National Heart, Lung, and Blood Institute has more about coronary artery bypass surgery.



-- Robert Preidt



Canadian Medical Association Journal, news release, Dec. 2, 2008


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

Related medicine news :

1. Employees Have Yet Another Reason To Lose Their Office Chairs In Favor Of A Treadmill Desk: Their Brain
2. Rowenta, Iron Manufacturer, Pits Marines, Quilters, Mothers and Daughters Against One Another to Help Iron Out Breast Cancer
3. Argentyn 23(R) Homeopathic First Aid Gel - Another Worlds First by Natural-Immunogenics Corp. for Healthcare Professionals
4. Philip Morris International Forced to Drop Another Concert Sponsorship; Philippines Health Department Applauded for Taking Action
5. Philip Morris International Caught in Philippines in Another Concert Sponsorship
6. Scientists identify another piece of the weight-control puzzle
7. Another new wrinkle in treating skin aging
8. Announcing Another Great Reason to Eat Chocolate
9. U.S. Patent Office Allows Another Significant VNUS Patent
10. Drugs, Doctors and Death: Heath Ledger Becomes Another Victim
11. Another way to grow blood vessels
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Another Study Warns of Risk From Cardiac Surgery Drug
(Date:1/17/2017)... ... 17, 2017 , ... SC&H Group, a leading audit, tax, and consulting firm, ... IT Advisory Services practice . Rossi is the third technology consulting leader to join ... guidance grows, and the practice continues to expand.     , Bringing more than 25 years ...
(Date:1/17/2017)... ... 2017 , ... Seceon , the only threat detection ... announced a strategic partnership with TechLab Security, a leading Enterprise Systems ... Security has become a strategic partner and a value added reseller of Seceon’s ...
(Date:1/17/2017)... TX (PRWEB) , ... January 17, 2017 , ... ... Texas families from two offices in Tyler, has announced the latest beneficiary of ... Ribbon Wish Network, a nonprofit organization dedicated to fulfilling the dreams of terminally ...
(Date:1/17/2017)... ... 2017 , ... Many people make New Year’s resolutions or renew their commitment to better health ... easier for people who want to kick off 2017 with better smiles. Dr. Mondavi is ... These special offers include: , , A new patient package for ...
(Date:1/17/2017)... Litlle Falls, NJ (PRWEB) , ... January 17, ... ... Museum and Learning Center and the Montclair State University’s Athletic Training Education program ... Montclair State University’s Athletic Training Education Program, which is consists of both ...
Breaking Medicine News(10 mins):
(Date:1/16/2017)... Research and Markets has announced the addition of the "Non-Invasive ... Growth Potential, Competitive Strategies and Forecasts: 2017 - 2021" report ... ... 11 major NIPT test by the year end of 2021. ... market and contains thoughtful insights, facts, historical data, and statistically supported ...
(Date:1/16/2017)... -- Infusion pumps and accessories are class of ... a controlled, precise and automated manner. These devices ... care, pain management and other applications, where continuous ... and pain free. These infusion systems help in ... life threatening circumstances or even sometimes to death ...
(Date:1/16/2017)... , Jan. 16, 2017   The Harrington ... Cleveland, Ohio , has announced the ... support breakthrough discoveries of physician-scientists whose research shows ... The Harrington Discovery Institute – part of ... an unmet need in academic medicine: to advance ...
Breaking Medicine Technology: