Trasylol® is a drug manufactured and distributed by Bayer and used during coronary artery bypass grafting surgery often called a “CABG” procedure. It is used to control bleeding and minimize the need for blood transfusions. Recent studies suggest that Trasylol® causes, among other things, an increase in the risk of serious kidney damage, resulting in dialysis or even death.On January 26, 2006 a study done by Dennis Mangano, MD and published in the New England Journal of Medicine showed that Trasylol® was associated with a doubling in risk of kidney failure requiring dialysis among patients undergoing complex coronary artery surgery or primary surgery. The study also concluded that replacing Trasylol® with one of two safe generic drugs would annually prevent as many as 11,050 dialysis complications, save $1 billion in healthcare (dialysis) costs, and reduce drug costs by $250 million. Another study published in the journal Transfusion also suggested that Trasylol® administration increased the risk for renal dysfunction or failure.
In February 2006, Bayer issued a “Dear Dr. Letter” to U.S. Healthcare Professionals notifying them of the results of the two studies and of the review of the studies by the FDA. Bayer specifically stated, “Bayer supports these actions by the FDA. We have been working and will continue to work closely with the FDA and other regulatory authorities in countries where Trasylol® is marketed to address questions regarding product safety. We share the company’s data on Trasylol® with regulatory authorities on an ongoing basis and welcome their evaluation of these published reports.”
In its Stockholders’ Newsletter First Quarter 2006, Bayer acknowledged that two separate studies reported a possible link between the use of Trasylol® and severe renal dysfunction or cardiovascular or cerebrovascular problems in patients treated with this drug. Bayer further stated that the studies were being evaluated by the FDA and the EMEA.
On September 21, 2006, the FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol®. During that meeting, the committee discussed the findings from the two published observational studies.
Then, on September 27, 2006, the FDA learned of another study actually conducted by Bayer. The newly discovered studies reported that use of Trasylol® may increase the chance for death, serious kidney damage, congestive heart failure and strokes. On September 29, 2006, the FDA announced that Bayer had failed to reveal the results of the study. Consequently, the FDA released a public health advisory stating that the undisclosed study demonstrated the “use of Trasylol® may increase the chance for death, serious kidney damage, congestive heart failure and strokes.”
Contact us if you believe you have suffered kidney failure, heart failure or stroke after receiving Trasylol.