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A new study reports that Trasylol, a drug used in open-heart surgery to prevent bleeding, increases the patient''s long-term risk of death by almost 50 percent.
If Trasylol use is halted, an estimated 10,000 deaths around the world could be prevented over the next five years, said the study, published in the Journal of the American Medical Association .
The study was founded by the Ischema Research and Education Foundation. It said that Trasylol, generically known as aprotinin, was unnecessary for most patients because there are safer, cheaper alternatives.
Lead author of the study Dr. Dennis T. Mangano said that Trasylol use should be reserved for those who are severely at risk of bleeding during open-heart surgery.
I would use this drug as a last resort,” said Mangano.
The Study
The study looked at the records of about 3,900 patients who underwent heart bypass surgeries at 62 health care facilities in 16 countries. It compared patients who were given Trasylol with those who were given another drug or none at all.
The study found that 20.8 percent of Trasylol takers died within five years, compared with only 12.7 percent who died after receiving no medicine. Even after adjustments were made to account for patient differences and other factors, those who took Trasylol had a 48 percent higher risk of death compared with those who took no drugs, the researchers said.
Researchers suspect that the drug may cause death in the long-term because it works by inhibiting the body''s production of a substance that dissolves clots. Some of these clots may linger and increase in size until they eventually cause a heart attack or stroke.
Not the First Time
This drug has come under scrutiny more than once since its FDA approval in 1993. Notably, in 2006 researchers linked Trasylol to an increased risk of heart failure, heart attack, stroke, and kidney failure. After that report, published in the New England Journal of Medicine, the FDA forced Trasylol to include a warning on the label about kidney failure.
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