German pharmaceutical giant Bayer AG announced the withdrawal of the controversial heart surgery drug Trasylol (generic name aprotinin) after a Canadian study suggested that it increased death rates among patients.
The drug is given to patients before heart surgery to reduce the risks of excessive bleeding. It did not have approval for use in India.
Bayer AG made the announcement under pressure from the FDA, which said it could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks. Bayer said in a statement that it still believed Trasylol was beneficial when used as directed.
Two weeks ago, researchers from the Ottawa Health Research Institute stopped a study of Trasylol in 3,000 heart bypass and valve surgery patients because although those given the drug bled less, they were half again as likely to die as those given two older alternatives.
The study was the latest in a series of worrisome signs that Trasylol could be dangerous. Last year, a study published in The New England Journal of Medicine found in 2006 that the drug increased the risks of kidney failure, heart attack and stroke.
“The drug has had FDA approval since 1993 and imported drugs were used by some in India the mid-nineties. Cardiac surgeons, however, stopped its use here after concerns about its safety emerged and it was found to cause blockages in the arteries of people undergoing bypass surgery,” says cardiac surgeon Ganesh Mani, chairman, Heart and Lung Institute, New Delhi.
Apart from the lack of substantial health risks, other drugs such as aminocaproic acid and tranexamic acid are also far less expensive.