A recent study based on observations at 69 leading cardiac centers around the world was published regarding Bayer Pharmaceutical's heart surgery drug Trasylol. Kidney failure, heart failure, and stroke are side effects associated with Trasylol heart surgery patients according to the study published by Mangano et al. in January 2006 in the New England Journal of Medicine (NEJM).

Each year approximately one million patients undergo surgery following a heart attack. The majority of patients who are at increased risk of bleeding during surgery have the option of one of three antifibrinolytic drugs to limit blood loss: Trasylol (Aprotinin), Amicar (aminocaproic acid), or Cyklokapron (tranexamic acid). These drugs work by inactivating an enzyme called plasmin so it stops from breaking down blood clots which helps prevent bleeding.

The observational study published in the (NEJM) raised significant concerns regarding the safety of Trasylol. The study revealed that Trasylol doubled the risk of kidney failure along with other serious side effects including stroke and heart attack. Trasylol has been on the market for use in cardiac surgery since its approval in 1993. It is estimated that as many as 10,000 patients may be on kidney dialysis due to Trasylol. Kidney failure was not associated with the less costly generic drugs aminocaproic acid and tranexamic acid according to the study.

The FDA has approved revised labeling for Trasylol following a review of safety information. On September 21, 2006, the FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety of Trasylol. The Trasylol labeling changes are based upon the recommendations of that advisory committee. The new label states that Trasylol should only be administered to patients who are at an increased risk for blood loss during heart surgery. The label changes include a warning that Trasylol increases the risk for kidney damage. The costs associated with patients suffering from Trasylol kidney failure are significant. Average annual dialysis costs per patients are over $66,000.

Dialysis is a type of renal replacement therapy which acts as an artificial kidney for patients who have lost kidney function due to renal failure. There are two primary types of kidney dialysis treatment: hemodialysis and peritoneal dialysis. The overwhelming majority of dialysis patients receive hemodialysis where the blood is circulated outside the body through a hemodialyzer, cleaned and then returned to the patient. Hemodialysis treatments are typically performed three times per week, with each session lasting 3 to 5 hours. Dialysis involves substantial cost, whether it is hemodialysis or peritoneal dialysis.

On September 29, 2006, the FDA announced that Bayer had informed the agency of an additional Trasylol study. The result of the study suggests that in addition to serious kidney damage, Trasylol may also increase the risk of death, strokes, and congestive heart failure. It is estimated that the replacement of Trasylol with the generic drug aminocaproic acid would prevent kidney failure and related dialysis treatment in 11,050 patients per year saving more than $1 billion per year. Replacement of Trasylol with the generic drug tranexamic acid would prevent 9790 renal complications requiring dialysis each year with similar annual savings.

Trasylol kidney failure is a serious side effect that requires further study and may result in additional labeling changes. Mangano et al., in their January 26, 2006 study, suggest that given the serious risk of kidney damage and other side effects continued Trasylol use is not recommended due to the availability of less expensive generic drugs that are not associated with serious cerebrovascular events and renal dysfunction.