If you’re scheduled for heart surgery or have a history of heart disease, you definitely want to look into this latest development. A recent study has unearthed some extremely concerning news about a popular blood-clotting drug that is used during heart surgery — it could up your risk of kidney failure, stroke, and, shockingly, heart attack.
The drug on question — aprotinin — is sold by drug giant Bayer AG under the brand name “Trasylol.” The drug, which was approved by the FDA in 1993, is injected into a patient during cardiopulmonary bypass (CPB) surgery to reduce bleeding and to minimize the need for blood transfusions.
The observational study, reported in a well-recognized journal, looked at 4,374 heart surgery patients on a global scale. Each patient received either one of three clotting drugs — aprotinin (1,295 patients), aminocaproic acid (883 patients) or tranexamic acid (822 patients) — or no clotting drug (1,374 patients).
Out of those given aprotinin, the patients who had surgery to unblock a clogged artery (3,013 patients), and the patients who had more complex operations (1,361) all had double the risk of kidney failure requiring dialysis. The former group also experienced a 55% increase in the risk of heart attack or heart failure, and a 181% increase in the risk of stroke or encephalopathy (brain disease). These numbers are staggering, especially when you consider that this drug has been in use for about 13 years now.
The patients who were injected with the other two clotting drugs did not experience any of these increased risks; however, aminocaproic acid and tranexamic acid were just as effective as aprotinin when it came to limiting bleeding in the surgery patients.
The maker of this latest controversial drug maintains that its own studies have proven aprotinin to be safe and questions the accuracy of an “observational study” versus a randomized trial. However, others feel that Bayer might be a little biased, especially considering that the drug achieved $210 million in worldwide sales in 2005. Obviously, the FDA needs to look into this issue.
In the meantime, you should know that the use of aprotinin (a.k.a. Trasylol) might have serious effects on your heart, kidney, and brain function. If you’re going to be undergoing heart surgery, discuss the available options with your doctor and surgeon.
The other two drugs examined in the study — aminocaproic acid and tranexamic acid — both seem to be safer alternatives and could even be cheaper, as there are generic versions available. Think about it: Do you actually want to risk doing greater harm to the organ you’re trying to heal?