Bayer’s Trasylol is safe and effective when used to prevent blood loss in patients undergoing coronary artery bypass grafting (CABG) surgery, according to a US Food and Drug Administration advisory panel.
The vote of confidence from the panel comes after the FDA issued a health warning earlier this year suggesting that Trasylol (aprotinin) was linked to higher risks of kidney problems, heart attacks and strokes.
The move was prompted by an article in the New England Journal of Medicine which suggested that Trasylol more than doubled the risk of kidney failure in patients who received it whilst undergoing open heart surgery, and another in Transfusion suggesting that more patients saw declines in kidney function on Bayer’s drug than on an alternative treatment.
The FDA panel weighed up this evidence, but concluded that while there was some indication that Trasylol could increase the risk of kidney dysfunction, any link to heart attack or stroke was purely speculative.
There was also debate about the drug’s possible risk of causing an allergic reaction, although as this is already included n the labelling – and Bayer is developing a test to identify those at risk – the panel considered no new measures were needed to address this issue.
On balance, the benefits of the drug in treating CABG patients outweighed these safety considerations, it was concluded, although a number of panellists said the drug should be reserved for those patients at high risk of bleeding.
Trasylol sales were 75 million euros ($95 million) in the first half of 2006, though had dipped back 11% in the second quarter on the back of the safety concerns. Bayer has forecasted peak annual sales for the drug in the region of 500 million euros. Trasylol was first introduced in the USA in 2003.