FDA to review increased Trasylol death risk after study halted

Carl Saiontz

By Carl Saiontz
Posted October 28, 2007


The FDA announced this week that they will take another look at the overall risks and benefits of Trasylol, a heart surgery injection used to control bleeding.  Trasylol has been previously linked to an increased risk of serious and potentially fatal injuries, such as kidney failure, heart attacks and strokes.  Recently a Canadian study was stopped after evidence clearly suggested that Trasylol increases the risk of death when compared with other drugs.

>>INFORMATION: Trasylol Lawsuits

Trasylol is the brand name for an aprotinin injection, which is manufactured by Bayer Pharmaceuticals Corp.  It is given to prevent excessive bleeding during heart surgery and to avoid the need for a blood transfusion.  It works by blocking enzymes that dissolve blood clots, reducing the risk of serious blood loss.

Although an FDA advisory panel reviewed the safety of Trasylol last month, the agency indicates that they anticipate a re-evaluation after the findings of the study in Canada regarding the Trasylol death risk.

The Canadian trial is known as the “BART study” (Blood conservation using Antifbrinolytics: a Randomized Trial in a cardiac surgery population).  It was designed to establish that Trasylol was better than epsilon-aminocaproic acid and traexamic acid in decreasing blood loss associated with cardiac surgery.

Researchers intended to enroll approximately 3,000 Canadians who were undergoing cardiac surgery, which could place them at a risk for bleeding.  However, the Data Safety Monitoring Board recently recommended that researchers stop patient enrollment in the Trasylol treatment group.  Preliminary data from the study found that:

  • There was a statistically significant increase in the risk of death at 30 days after use of the heart surgery injection
  • While Trasylol was associated with less serious bleeding, more people who received Trasylol died due to hemorrhage than in those who received a different drug.

Last month, an outside panel of FDA advisors met and recommended that the U.S. regulatory agency not issue a Trasylol recall, depite evidence that it is linked to an increased risk of death and other serious injuries.  However, following the findings of the Canadian researchers, the FDA will now reevaluate the risks and benefits of Trasylol and determine whether label changes or other regulator actions may be necessary.

On Thursday, the FDA issued an early communication warning that healthcare providers who are considering the use of Trasylol should be aware that data suggests the Trasylol death risk is increased when compared to other antifibrinolytic drugs.


The lawyers at Saiontz & Kirk, P.A. have been reviewing potential Trasylol lawsuits since February 2006.  Many individuals are unaware that they received the aprotinin injection before heart bypass surgery, so potential claims are being investigated for any individuals who suffered kidney failure, a heart attack, stroke or death following heart surgery.  If you, a friend or family member suspect you may have a claim, request a free consultation.

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