FDA panel does not recommend Trasylol recall

By Harvey Kirk
Posted September 17, 2007

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An FDA advisory panel met last week and found that a Trasylol recall is not warranted at this time, despite evidence that suggests the drug may increase the risk of kidney failure, heart failure, stroke and death.  The recommendation was made after the panel of experts had an opportunity to review additional data which the manufacturer, Bayer AG, failed to provide to the FDA before a prior hearing in September 2006.

>>PRIOR POST (9/11/2006): Heart surgery injection increases risk of
kidney failure and death

Trasylol is a heart surgery injection given to control bleeding and reduce the need for a blood transfusion as a result of bypass surgery.  However, studies released in 2006 suggested that use of the drug doubled the risk of kidney failure, leading to a  “black box” warning which was added in December.  Two more recent studies have suggested that the injection could also increase the risk of death.

Prior to the hearing last week, the FDA provided documentation to the panel which suggested that the use of Trasylol is associated with an increased risk of death, renal failure, heart attack and stroke.  After reviewing new data which they did not have in September 2006, the panel of outside experts recommended that additional studies be conducted to look at the safety concerns and said that the label should be updated to discuss the potential of an increased risk of death.

TRASYLOL LAWSUITS

As a result of the manufacturer’s failure to provide accurate and complete warnings about the problems associated with the heart surgery injection, serious and potentially life threatening injuries have been suffered by individuals after undergoing heart-bypass surgery. 

Trasylol injection lawsuits are being reviewed throughout the United Stated by the lawyers at Saiontz & Kirk, P.A.  If you, a friend or family member suffered kidney failure requiring dialysis, a heart attack, stroke or death after receiving an injection to control bleeding during heart surgery, request a free claim evaluation.