NEW YORK: A costly drug administered on patients undergoing coronary artery bypass surgery to control excessive bleeding is associated with increased risk of the patients dying even five years after the surgery, according to new research.
The drug, aprotinin, sold under brand name Trasylol by Bayer AG has been in use since 1985 and at least four million patients worldwide are reported to have received it. Trasylol had received FDA approval for use in coronary bypass surgery in 1993.
Trasylol had been under watch for over a year as one study in January 2006 had found it linked to severe kidney problems, heart attacks and strokes in patients undergoing the bypass surgery. A separate study has found it to be linked to kidney trouble. These studies led the FDA to set up an advisory panel which, however, ruled that the drug should stay in market.
But based on discovery that Bayer did not mention to the advisory panel about the known and serious kidney damage, death, heart failure and stroke, the FDA directed updated labeling for the drug warning about kidney problems and saying it should be used only in coronary bypass surgery and on patients prone to excessive bleeding.
The new study, which is based on five years of data on 3,876 heart bypass patients from around the world, establishes that the death rate among the 1,072 patients, who were given Trasylol was nearly 21 per cent, two-thirds higher than the mortality rate among surgery patients not given anti-bleeding drugs.
The study was conducted by Dr Dennis Mangano of the Ischemia Research and Education Foundation of San Bruno, California.
A majority of the deaths in the study were caused by heart attacks, heart failure, strokes or kidney failure. Mangano said it has been observed that clots created by the drug were likely build up over time and block arteries, starving organs of oxygen.
Mangano says Trasylol costs $1,300 per use, while another effective drug, Aminocaproic acid costs $44. Yet another drug that can be used, tranexamic acid, costs only $11.
The details of the study have been published in the Journal of the American Medical Association.
Bayer responded to the study saying the finding is not exactly correct as the drug is usually given to the sickest patients more likely to die if they bleed excessively.
Mangano, who had conducted the January 2006 study too, said about half of the bypass patients in the U.S. had received Trasylol. However, this had dropped to 37.5 per cent in the first half of 2006.
Mangano advises patients to ask their doctors what drug, if any, they will be given to slow bleeding during heart surgery and to ask questions about the risks.
