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Bayer’s Trasylol Clotting Drug Boosts Heart Risk, Study Says

Trasylol Double The Risk Of Heart Attack And Stroke. Bayer AG’s Trasylol, used in more than 60 countries to control bleeding after surgery, doubles a patient’s likelihood of developing kidney failure and increases the risk of heart attacks and strokes, researchers said. Scientists led by Dennis Mangano at the Ischemia Research and Education Foundation in […]

Trasylol Double The Risk Of Heart Attack And Stroke. Bayer AG’s Trasylol, used in more than 60 countries to control bleeding after surgery, doubles a patient’s likelihood of developing kidney failure and increases the risk of heart attacks and strokes, researchers said.

Scientists led by Dennis Mangano at the Ischemia Research and Education Foundation in San Bruno, California, said their research found the drug raised the risk of heart attack or heart failure by 55 percent and more than doubled the chance of stroke and encephalopathy, a breakdown of brain tissue. The study of 4,374 patients is in this week’s New England Journal of Medicine.

Bayer split off some chemical units last year as it tried to recover from the 2001 recall of the cholesterol treatment Baycol. Last month, the Leverkusen, Germany-based company said Trasylol may bring in 500 million euros ($614 million) in annual sales, and Bayer’s studying its use in areas such as hip surgery. Mangano’s study may undercut the use of the drug, also known as aprotinin, which was introduced in 1993.

Associations Between Aprotinin And Serious End-Organ Damage

The “associations between aprotinin and serious end-organ damage indicates that continued use is not prudent,” Mangano said in the study. “In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives.”

Trasylol costs at least 10 times more than aminocaproic acid and tranexamic acid, the researchers said. While Trasylol and the two generic products limited bleeding, aminocaproic acid and tranexamic acid aren’t linked to kidney, heart or brain damage, they said.

Bayer withdrew Baycol, a member of the statin class of medicines, in August 2001 after some patients developed muscle weakening and kidney failure. The drug was linked to as many as 100 deaths.

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