Trasylol News
Patients given popular heart surgery drug had higher risk of dying: study
-The Ottawa Citizen
05/15/2008 - Patients who received a drug commonly used to control bleeding during heart surgery were at a higher risk of dying, new research by the Ottawa Health Research Institute reveals.
The study, published Wednesday in the New England Journal of Medicine, provides hard evidence that patients given aprotinin were more likely to die from post-surgery complications that those given two cheaper generic clotting medications.
"The risks of aprotinin are greater than its benefits," said Dr. Paul Hébert, a senior scientist at the institute and a co-author of the study.
According to U.S. estimates, more than 4.77 million patients have received the medication since it was approved in 1993. The drug was approved to minimize bleeding in patients undergoing repeat heart surgery or multiple cardiac procedures.
"Up until recently, those undergoing a high-risk heart procedure probably would have received aprotinin over the two other drugs," said Dr. Dean Fergusson, the study's lead author.
Worldwide sales of aprotinin, sold under the name Trasylol, were voluntarily suspended by Bayer Inc. last October after the Canadian study, known as the BART trial, was cut short because of evidence of increased deaths in patients who received aprotinin.
Concerns about the drug have mounted since 2006, after two studies found the drug increased the risk of kidney damage, heart failure, heart attacks and stroke. That prompted the U.S. Food and Drug Administration to convene a panel of experts to review the drug's safety. Based on the panel's recommendations, the FDA restricted use of the drug and added new warning labels.
But the FDA subsequently learned that Bayer had failed to inform the panel or the agency about another study that showed the drug might be linked to increased deaths. That prompted the agency to issue an unusual public health advisory and call for more research into the safety of the drug.
After the Ottawa study was halted last fall, government regulators around the world pressured Bayer to suspend sales. The company said the suspension would be temporary while it awaited the outcome of the Canadian trial.
In a statement responding to the study, Bayer indicated that it would review the data and consult with government regulators "to determine what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol."
But experts say it's "highly unlikely" that aprotinin will ever be used in heart surgeries again. "In all likelihood, this is the end of the aprotinin story," said an editorial accompanying the journal article.
In the large-scale trial conducted at 19 heart-surgery sites across Canada, researchers followed more than 2,000 patients who received one of three clotting drugs, including aprotinin.
Patients who took aprotinin were 50 per cent more likely to die from post-surgery complications such as heart attack, stroke or organ failure.
"For every 50 patients treated with aprotinin, one patient would die," said Dr. Hébert.
"It was a bit of a surprise to see this."
The study doesn't pinpoint the reason for the higher death rates, but researchers suggest aprotinin's clotting properties are to blame.
"We speculate that it worked a little bit better in preventing bleeding," said Dr. Hébert. "It also worked a little bit better in causing clotting. And that's why a few more patients died."
Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits fill out our free Trasylol case evaluation . Our on-staff nurse and attorneys are standing by to answer any questions you may have regarding Trasylol side effects, a possible Trasylol class action lawsuit, or any other type of Trasylol litigation.
