Trasylol is used in heart surgery to suppress blood loss. A January 2006 study in the New England Journal of Medicine claimed that use of Trasylol during bypass surgery can double a patient’s risk of kidney failure, heart attack, stroke and death. The manufacturer, Bayer, says the 2006 study was poorly conducted. Following that study, the FDA recommended that doctors monitor patients who have been given Trasylol.
In November 2007, pressured by regulators around the world, the drug’s manufacturer, Bayer A.G. announced that it had agreed to withdraw the controversial heart surgery drug after a Canadian study suggested that it increased death rates. The FDA has asked for a phased withdrawal of the drug, because of concerns that alternative medicines could run short.In May 2008, Trasylol was permanently withdrawn except in very restricted research situations.
Television News Report Reveals Unsettling New Information on Trasylol Recall
On February 17th, 2008, the investigative television program 60 Minutes aired a segment on the prescription drug Aprotinin, marketed by Bayer as Trasylol. In the report, we are given the sordid 14 year history of the drug; from concerns before its Food and Drug Association (FDA) approval, an aggressive marketing campaign during the early years of its introduction to the market, to numerous fatalities resulting from common Trasylol side effects .
Trasylol Manufacturer Removes Trasylol from Shelves after Increased Risk of Death Found
Under pressure from medical regulation agencies around the globe, the manufacturer of Trasylol (generic Aprotinin) announced on November 5, 2007 that it would remove the controversial heart surgery drug after a study conducted in Canada appeared to show an increased risk of death among patients on whom the drug was used. The drug’s maker, German pharmaceutical firm Bayer AG, has stated that it still believes the drug to be beneficial. According to the Food and Drug Administration (FDA) there are not many alternatives when it comes to patients at risk for excessive bleeding during heart surgery.
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