Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The drug Trayslol, manufactured by Bayer, used for limiting blood loss in patients undergoing cardiac surgery is associated with an increased risk of death, according to a new study.
Subscribe to our email newsletter
According to the researchers the safety of Trayslol, also known as aprotinin, came under scrutiny in 2006 after an observational study reported that aprotinin use was associated with a doubling to tripling of the risk of perioperative renal dysfunction and failure requiring dialysis in patients undergoing coronary artery surgery.
Scientists from the Ischemia Research and Education Foundation assessed survival rates at six weeks, six months and annually for five years for 3,876 patients undergoing coronary artery bypass graft (CABG) surgery.
The researchers examined death rates of these patients according to the use of three medications used to lessen bleeding, aminocaproic acid and tranexamic acid, aprotinin, or no anti-bleeding agent.
The researchers found that during five years, 223 deaths occurred among 1,072 aprotinin-treated patients, a death rate nearly two-thirds greater than control patients.
Rates were similar for aminocaproic acid patients with 132 deaths among 834 patients, and for tranexamic acid patients there were 65 deaths among 442 patients.
“Use of aprotinin among patients undergoing CABG surgery does not appear prudent because safer and less expensive alternatives are available,” the authors concluded.
Bayer responded to the study by saying that the methodological and analytical approaches used were not reliable.
Bayer also pointed out the researchers did not address the bias that generally sicker patients were administered with the drug and already had a higher risk of dying when participating in the study.