Clotting drug increases kidney risk, study findsJan 26, 2006 | AP
A drug commonly used to prevent excessive bleeding in heart-surgery patients greatly increased the risk of kidney failure, a new international study found.
The drug aprotinin marketed under the brand name Trasylol is the second clotting medication in two weeks linked to serious complications.
Heart-bypass patients who were injected with Trasylol during surgery had double the risk of kidney failure and an increased risk of heart problems compared with those who got other drugs, researchers reported in today's New England Journal of Medicine.
"Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery," wrote Dr. Dennis Mangano of the Ischemia Research and Education Foundation, which led the study.
The San Bruno, Calif.-based foundation is a nonprofit organization founded in 1987 that funds cardiovascular research.
The Food and Drug Administration approved Trasylol in 1993 to control bleeding in patients undergoing open-heart surgery and minimize the need for blood transfusions. The drug works by blocking enzymes that dissolve blood clots.
Trasylol's maker, Germany-based Bayer AG, insists the drug is safe based on its own experiments but said it alerted regulatory authorities in the United States, Canada, Australia and Europe about the latest research.
Trasylol is the latest clotting drug to spark safety concerns. Last week, other researchers reported that the hemophilia drug Novoseven was linked to deaths, heart attacks and strokes in patients who took the drug to treat other types of excessive bleeding, such as cerebral hemorrhages.
Global sales for Trasylol reached $210 million in 2005, according to Bayer. Last month, chief executive Werner Wenning put the sales potential for the drug at more than $600 million.