Safety Of Heart Drug Questioned

Reports of increased incidence of kidney failure following use of the drug aprotinin, marketed as Trasylol, has prompted necessity for reconsidering the use in heart surgery patients.

Reports of increased incidence of kidney failure following use of the drug aprotinin, marketed as Trasylol, has prompted necessity for reconsidering the use of the drug in heart surgery patients. The clotting drug is commonly used to prevent excessive bleeding in patients undergoing cardiac surgery.

It has now been found from the present study that Trasylol injected patients were twice as likely to develop kidney failure and suffer from heart disorders compared to controls who received other drugs. The results of the study can be found in the New England Journal of Medicine.

The U.S. Food and Drug Administration (FDA) approved the drug for use in 1993. The primary indication was to control the bleeding and reduce necessity of blood transfusion in patients who underwent open-heart surgery. The drug acts by blocking the function of enzymes that are involved in the clot dissolving process.

The drug manufacturer, Bayer AG, a German based concern in response has stated that the drug has been approved following demonstration of adequate safety level in trials conducted by the company itself. Drug regulatory boards in Canada, Europe, Australia and United States have been alerted regarding the above research.

Last week, concerns were raised regarding the use of Novoseven, a drug used for management of cerebral hemorrhages (primary indication is for treatment of hemophilia). Increased risk of heart attack, stroke and even death were reported with use of the drug.

The researchers examined the effect of Trasylol in nearly 4,374 cardiac surgery patients. The study participants were given either Trasylol or a placebo. At the end of the study, the incidence of kidney failure, requiring dialysis was twice as likely in patients who took Trasylol when compared to the control group. The risk of heart attack or heart failure was 55% greater amongst Trasylol users.

Although anesthesiologists and surgeons have been raising concerns regarding the use of the drug, it is for the first time that a comprehensive study regarding safety of Trasylol has been conducted. More studies are clearly indicated in the future to accurately predict the risk-benefit ratio of such dangerous blood-thinning drugs.