Bayer’s Trasylol Poses Higher Death Risk Among Patients, Studies Say

-enews20.com

02/21/2008 —Two recent U. S. studies reinforced the already existing claims that the Bayer AG’s clotting drug Trasylol poses a deadly risk on heart surgery patients.

The German pharmaceutical giant Bayer AG stopped selling the drug last fall, after a Canadian study was halted as many patients taking Trasylol had died.

One of the studies examined more than 10,000 patients who had undergone bypass surgeries at the Dukes University Medical Center from 1996 through 2005. The result was that 6.4% of patients given Trasylol died within 30 days from the surgery, which was 2 .5 times higher than patients who were given another drug or no drug at all for excessive bleeding. The study confirmed the incidence of kidney damage due to the use of Trasylol.

“There continues to be an association between aprotinin and higher death rates and kidney damage,” said Dr. Andrew Shaw, an associate professor of anesthesiology at Duke University and the lead author of the study, the Washington Post reports.

The other study was funded by Bayer, and involved more than 78,000 people from 2003 to 2006. The risk of death was 64% higher in Transylol group.

The pharmaceutical company had the results before a September 2006 federal hearing in which the FDA discussed the drug’s safety, but it intentionally withheld them. If the FDA had known the results, it would have stopped the selling of the drug earlier.

Bayer faces lawsuits from federal officials and from patients, for putting a risky medicine in the hands of doctors. It is believed that the lives of 22,000 people would have been spared if the drug had been recalled earlier.

Both studies, published in this week’s issue of the New England Journal of Medicine, represent a strong body of evidence that Trasylol is a dangerous drug. However, Bayer said in a statement this week that both studies are flawed.

Trasylol, also known as aprotinin, has been used to control bleeding in hundreds of thousands of patients who had undergone heart surgeries for 14 years, since the Food and Drug Administration approved it in 1993. It became the first choice for surgeons, after studies showed its clotting effects.

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.