FDA reviews new studies on Bayer's Trasylol
Bayer HealthCare is working with global regulatory authorities over recently published studies in the medical literature which suggest its Trasylol (aprotinin injection) can increase the risk of heart failure, stroke and kidney failure. The US Food & Drug Administration (FDA) is evaluating the studies to determine if labelling changes or other actions are warranted.
Bayer HealthCare is working with global regulatory authorities over recently published studies in the medical literature which suggest its Trasylol (aprotinin injection) can increase the risk of heart failure, stroke and kidney failure. The US Food & Drug Administration (FDA) is evaluating the studies to determine if labelling changes or other actions are warranted.
Trasylol is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery.
A recent study, published in the New England Journal of Medicine, reported that patients who received Trasylol had higher rates of serious kidney problems, heart attacks, and stroke compared to treatment with other drugs to prevent bleeding or to no treatment; a second study, reported in Transfusion, said more cases of decreased kidney function were found in patients treated with Trasylol compared to another treatment to prevent bleeding.
Bayer said it welcomed and supported both a review and evaluation of the new studies which it says are merely 'observational' have 'methodological limitations'.