Two studies published in the New England Journal of Medicine have linked the drug Trasylol, used to reduce bleeding during open-heart surgery, to an increased risk of death and kidney damage among other concerns. Patients taking Trasylol were found to be 27 percent more likely to die a decade after surgery than those who received a rival drug in a study of over 10,000 patients. Another study of over 78,000 patients, which was originally withheld by Bayer, found a 78 percent increased risk of death within a week following the surgery. Trasylol was approved in 1993 and became stronghold in 2005 generating $333 million in sales. Trouble however would soon follow as the next year an international study linked the drug to higher rates of heart attack, stroke, kidney failure and death. The German based Bayer halted sales Trasylol last year after a Canadian study tied the drug to higher death rates.
More than 200,000 bypass patients a year worldwide were getting Trasylol before sales were halted. The company has said 4.3 million people have been treated with the injectable drug. It costs 10 times more than its closest rival.
Two FDA advisory panels have recommended that Trasylol remain on the market despite concerns, citing that the data is inconclusive. The patients who received Trasylol were sicker, which cold have altered the results even after adjustments were made.
The Trasylol dilemma gives emphasis to the need for medications to be studied more intensely before widespread use by the public.