Trasylol Linked to Thousands of Deaths(2)
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Jennifer MooreFebruary 23, 2008 10:50 AM60 Minutes recently reported that the drug, Trasylol, may be linked to the death of thousands of patients. Trasylol had been on the market for 14 years and was made by Bayer. Estimates show that worldwide over four and a half million people have been given the drug -- about a third of them were Americans. Trasylol was given in the operating room to control bleeding. Bayer aggressively marketed the drug and Trasylol was being used in about 1/3 of all cardiac bypass operations. Trasylol is now off the market, but can still be used in special cases during surgery.
Two studies confirmed that Trasylol causes an increased risk of death and kidney damage compared to alternative medicines or taking no medicine at all. The stories were published in the New England Journal of Medicine.
One study showed elevated risks of kidney damage, including dialysis, heart attack and stroke. According to the 60 minutes report, the delay in taking the drug, Trasylol, off the market may have cost 22,000 lives. The physician behind the study, Dr. Dennis Mangano, estimates that as many as 1,000 people per month died as a result of the use of Trayslol during coronary bypass surgery from the publication of his article in January, 2006 until the drug's withdrawal in November of 2007.
Trasylol is an antifibrinolytic agent used during cardiac surgery to reduce the risk of blood transfusions. However, two alternatives exist, which are substantially less expensive than Trasylol. According to the two most recent articles and Dr. Mangano's study, these alternatives are equally effective in reducing the risk of needing blood transfusions due to blood loss and present none of the health risks associated with Trasylol.
...there had been concern about the drug as far back as the early 1980's. It was then, in Bayer's hometown, that Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. He told Bayer, but he was surprised by the drug company's reaction. "I felt that Bayer wasn't interested to examine these side effects," Fischer says.
Soon, the same side effects were being seen in humans in America.
"The most common problem we saw was renal failure. That is, that kidneys did not function properly after surgery," says the Missouri Baptist Medical Center's Dr. Nicholas Kouchoukos, one of this country's top heart surgeons.
In 1992, he conducted a small study, not funded by Bayer, in which Trasylol was given to 20 patients.
"Thirteen of these patients had problems with kidney function after the procedure," Kouchoukos says.