Trasylol (aprotinin)

Trasylol, known generically as Aprotinin, is manufactured by Bayer AG and is administered by injection during cardiac bypass surgery to induce clotting in the blood, preventing hemorraghing.

Trasylol doubles risk of serious damage to major organs

A study reported January 25, 2006, in the New England Journal of Medicine shows that Trasylol is linked to serious side effects. The study of 4,374 patients demonstrated that Trasylol at least doubles the risk of kidney failure and stroke, or encephalopathy, and raises the risk of heart failure or heart attack by 55 percent. The study estimates that as many as 10,000 patients may now be on dialysis due to kidney failure after cardiac bypass surgery where they were administered trasylol. In the study, data was collected from more than 4,300 patients undergoing revascularization surgery at more than 69 centers around the world between 1996 and 2000. The patients received either Trasylol, aminocaproic acid, tranexamic acid or no treatment.

The Trasylol group had double the risk of renal failure requiring dialysis usually observed in patients undergoing complex coronary-artery surgery or primary surgery. The group also had a 48% increased risk of heart attack, a 109% increased risk of heart failure and a 181% increased risk of stroke or encephalopathy. The two generic drugs used in the study, aminocaproic acid and tranexamic acid are not only significantly less expensive than trasylol but much less riskier. Neither group that received the generic drugs exhibited these increased risks.

Halting Trasylol use might prevent 10,000 kidney failures a year

The study's lead author, Dr. Dennis Mangano of the Ischemia Research and Education Foundation in San Bruno, CA, was quoted as saying that, "In good conscience, I could not administer (Trasylol) to this group of patients, especially given the availability of safer alternatives." The article said halting aprotinin use globally would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs, as well as nearly $250 million spent on the drug itself (Source: Thomas H. Maugh II, "Multiple Risks of Surgery Drug Seen," Los Angeles Times, January 26, 2006).

While Trasylol is only approved for specific heart surgeries, it is commonly used for other surgeries including orthopedic procedures. Worldwide, approximately 1 million people per year have coronary artery bypass graft surgery, with nearly 2/3 of them given trasylol during the procedure.