February 13, 2007
Study links Bayer’s Trasylol to death risk
Bayer’s Trasylol, used to prevent excessive bleeding during heart surgery, raises the risk of death within five years of administration by nearly 50%, a study published in last week’s Journal of the American Medical Association (JAMA) shows.
The study’s authors suggested that replacing the drug with other, cheaper drugs for a year would prevent 10,000 deaths globally, over the next five years.
The study followed 3,876 patients who had heart bypass surgery at 62 medical centers in 16 countries. The researchers compared patients who received Trasylol to patients who got other drugs or no anti-bleeding drugs. Over five years, 20.8% of the Trasylol patients died, versus 12.7% of the patients who got other drugs or no anti-bleeding drug. When researchers adjusted for other factors, they found that patients who got Trasylol ran a 48% higher risk of dying in the five years afterward.
The same researchers behind this week’s JAMA study also found that Trasylol raised the risk of kidney failure, heart attacks and strokes in a study published last year. Most of the deaths in the new study were related to those problems, the researchers said.
Bayer said in a statement that the findings are unreliable because Trasylol tends to be used in more complex operations and the researchers’ statistical analysis did not fully account for the complexity of the surgery cases.
However Bayer said it would, “work with regulatory agencies and external experts in the field to further evaluate the findings.”