Study questions safety of heart surgery drug

Thursday, January 26th 2006, 10:35 am
By: News On 6

LOS ANGELES (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 to those who got other drugs, researchers reported in Thursday'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-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.

In the Trasylol study, researchers examined 4,374 heart surgery patients worldwide who received either one of three clotting drugs, including Trasylol, or a dummy medication.

Patients who took Trasylol had twice the risk of developing kidney failure that required dialysis and a 55 percent increased risk of a heart attack or heart failure. In contrast, those who took one of the two cheaper generic clotting medications had no harmful side effects.

In an editorial in the journal, Dr. Gus Vlahakes of Harvard Medical School, who had no role in the research, noted that the study is the most comprehensive, independent analysis yet of Trasylol's safety.

``Some surgeons and anesthesiologists who use the drugs have been concerned about its potential risks since it was first approved,'' Vlahakes wrote. ``Yet ... sufficient data have not been available for an analysis of the risks and benefits of aprotinin (Trasylol).''

Global sales for the drug reached $210 million in 2005, according to Bayer. Last month, chief executive Werner Wenning put the sales potential for the blood thinning drug at more than $600 million.