Recent reports about this drug are truly shocking. Trasylol is used during heart operations to control bleeding – important to be sure – but it turns out that while this drug destroys kidneys, two readily available and less expensive, generic drugs work just as well without the risk. A major indepedent study found that the risk of kidney failure and strokes is doubled with Trasylol. We have to wonder why it took so long for this to come to light. In litigation, we will certainly ask the question, “How long have you known about these cases of kidney damage from Trasylol?”
Anyone who had to go on kidney dialysis after heart surgery should consider contacting me using the form at the right. Please see my site devoted specifically to legal news and information regarding increased risk of kidney failure and strokes from Trasylol.
Bayer AG’s blood clot drug Trasylol (Aprotinin) has been associated with an increased risk of kidney failure, stroke risk and encephalopathy — a degenerative disease of the brain — in cardiac surgery, according to a study published in the New England Journal of Medicine.
The study, which was led by Dr Dennis Mangano, concluded that ‘the association between Aprotinin and serious end-organ damage indicates that continued use is not prudent. In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives’.
Trasylol was associated with a doubling in risk of kidney failure requiring dialysis among patients undergoing complex coronary-artery surgery or primary surgery.
Also, according to an abstract of the article in the journal, the drug was associated with a 55 pct increase in the risk of heart failure, and a 181 pct increase in the risk of stroke or encephalopathy.
The study, which involved 4,374 patients, compared Trasylol (1,295 patients) to aminocaproic acid (883 patients) and tranexamic acid (822 patients) or no agent (1,374 patients).
‘Neither aminocaproic acid nor tranexamic acid was associated with an increased risk of renal (kidney-related), cardiac or cerebral events,’ the article said.
Bayer said in a written statement that the study contradicts data and clinical experience with the drug made in the last 15 years.
‘Quite contrary to the study made by Mangano, Bayer has not observed an increased rate of renal failure, heart attacks, strokes or brain damage in its studies,’ the company said.
The company said Trasylol has so far been used and tested on almost 6,500 patients worldwide that have undergone open heart surgery, in a number of randomized, double-blind, placebo-controlled clinical studies.
‘Bayer HealthCare will now contact the author of this study in order to discuss the details of it. Also, the company has informed the regulatory authorities of the study,’ it said.
‘Patient safety is Bayer HealthCare’s top priority,’ and the company takes this study very seriously, it said.
Trasylol is currently approved for the prevention of post-operative blood loss and the need for blood transfusion in patients undergoing surgery.
It is also the only drug treatment approved by the US Food and Drug Administration to reduce bleeding and the need for blood transfusions during coronary artery bypass graft surgery.
In December the company announced it wants to apply for use of this drug in hip replacement surgery as well in the second half of 2006.
The company recently said it had hiked its peak sales potential guidance for this drug to above 500 mln eur. It had not communicated its previous sales guidance.