Bayer, maker of Trasylol (aprotinin), announced that a Canadian study had found preliminary evidence that patients having heart surgery were more likely to die within 30 days if they received aprotinin rather than other medicines used to reduce blood loss after surgery.
The study, called Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), aimed to find out whether aprotinin was better than tranexamic acid and aminocaproic acid at reducing bleeding after coronary artery bypass surgery or aortic valve replacement. Although aprotinin was more effective at stopping bleeding, it had a higher death rate.
The study was funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. Bayer said it would review the results and carry out further studies with the FDA and other regulators before deciding whether the drug would stay on the market.
Update: aprotinin was withdrawn from the market worldwide in 2008. European regulators later allowed its limited use again in some bypass surgery.
Like
Love
Angry
Dislike
