Heart bypass surgery injection increases risk of kidney failure and death
According to FDA staff members, a heart bypass surgery injection known as Trasylol (aprotonin), appears to increase the risk of kidney failure, heart attacks, strokes and death. The statement was yesterday in advance of an advisory panel meeting scheduled to begin tomorrow.
>>INFORMATION: Heart Bypass Surgery Injection Problems
The FDA advisory panel will meet in Washington, D.C. to review the safety of Trasylol and to evaluate new information about the side effects associated with the injection. An earlier advisory panel which met last year in September 2006, found that data indicated Trasylol carries significant risks, but the drug was allowed to remain on the market with stronger warnings and restrictions on the situations where it can be used.
Immediately following the 2006 advisory panel meeting, damaging data was released which strongly suggests that the Trasylol injection increases the risk of death, serious kidney damage, congestive heart failure and stroke. The manufacturer, Bayer AG, failed to provide the FDA with this information from a study involving about 67,000 records. Although the company claims that their failure to provide the data was only a mistake, it is suspected that employees at the company may have been attempting to conceal or cover up the damaging information.
At the advisory meeting tomorrow, a panel of experts will meet again to evaluate the new data and determine what steps need to be taken to protect consumers. Many believe that they should recommend a Trasylol recall, since cheaper and safer generic drugs are available which doctors could use for the same purpose. After reviewing the data, the panel could also recommend stronger warnings or further restrictions on the use of the drug instead of a recall. Although the FDA is not required to follow the recommendations of their expert panels, they usually do.
Trasylol is given as an injection before cardiac bypass surgery to reduce blood loss and prevent the need for a blood transfusion. The heart surgery injection was approved by the FDA in 1993, and has been heavily promoted by Bayer. Originally it was believed that the product could generate sales of over $500 million annually for the company, but Bayer has seen sales fall sharply since they were told to add the stronger warning to the label last year by the FDA.
BYPASS SURGERY INJECTION LAWSUITS
The Trasylol lawyers at Saiontz & Kirk, P.A. are investigating potential lawsuits for individuals who have experienced kidney failure, heart attacks, strokes or death after receiving a heart bypass surgery injection to control bleeding. Many individuals are unaware of the name of the injection they received, but following a free consultation, potential claims are further investigated to determine whether a Trasylol injection was administered.
To determine if problems suffered following heart surgery may have been caused by an injection before surgery, request a free claim evaluation.
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