Since its suspension from the market in November of last year, the adverse effects of Trasylol (aprotinin) have been well known. Although this antifibrinolytic drug was once used in nearly a third of CABG procedures to reduce intraoperative bleeding, an NEJM study published in 2006 revealed that it doubled the risk of renal failure and increased the risk of myocardial infarct by 55%. In other words, not a great choice of drug.
After a second study confirmed this result, the drug was finally pulled. The whole disaster was compounded by the fact that, apparently, Bayer knew about these problems all along but didn’t care to tell the FDA or anyone else until a whistleblower forced their hand.
Alas, the drug is back in the news this week because two new articles in NEJM (here and here) pore through almost 100,000 patient records to confirm that, yup, it’s a bad drug, and it killed lots of patients. Stay far, far away from it.
In a 60 minutes interview that aired last night, Dr. Dennis Mangano, author of the original 2006 study, estimates that 25,000 lives could have been saved had older, more reliable (and, mind you, much cheaper) drugs like aminocaproic acid and tranexamic acid been used instead. To see a video of the 60 minutes report, click the “more” link.
(our apologies for the ad — it’s from CBS)





1 response so far ↓
1 billdoc // Feb 25, 2008 at 3:14 pm
i’m not a CT surgeon, but it seems like the morbidity associated with this drug was clear to anyone paying attention … i understand that the second study you mention, out of canada, was stopped early because the effects of the drug were so obvious. why did it take so long for people to pick up on these problems and do something about them?
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