Originally published September 9 2008
Deadly Side Effects of Heart Surgery Drug Trasylol Confirmed in New Studies
by David Gutierrez, staff writer
(NaturalNews) Two new studies have added to the evidence that a drug commonly used to control bleeding during heart surgery increases the risk of kidney damage and death.
In November, drug-maker Bayer AG complied with an FDA request to remove the anti-bleeding drug Trasylol from the market in the United States after preliminary results from a large Canadian trial suggested that the drug could lead to kidney failure and death. Now two studies in the New England Journal of Medicine have found similar results.
In the first study, researchers from Duke University compared the rates of kidney damage and death among 10,000 heart surgery patients.
"There does appear to be an association between continued use of aprotinin and reduced kidney function," lead researcher Andrew Shaw said.
In addition, the death rate was 32 percent higher among surgical patients treated with Trasylol than among patients who received no anti-bleeding drug, and 27 percent higher than among those given the alternate drug aminocaproic acid.
In the second study, researchers from Harvard Medical School and Brigham and Women's Hospital compared the death and dialysis statistics for 78,000 coronary bypass surgeries, depending on whether patients had been given Trasylol or aminocaproic acid. They found that patients receiving Trasylol were 64 percent more likely to die than those receiving the other drug, and were significantly more likely to need dialysis treatment for kidney failure.
According to lead researcher Sebastian Schneeweiss, the data used in the study were already available to the FDA before the preliminary results of the Canadian study were announced and the agency asked Bayer to remove Trasylol from the market.
In an accompanying editorial, Dr. Wayne A. Ray of Vanderbilt University said the Trasylol case highlights the need to do comparative studies before new drugs are approved, rather than after.
Aminocaproic acid was already on the market when Trasylol received FDA approval.
"Had this been done 10 years ago with Trasylol, many lives would have been saved," Ray said.
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