Trasylol, also known as aprotinin, is a blood-clotting drug used during heart surgery to prevent bleeding, and was pulled from the market in November 2007 because of serious adverse side effects including renal failure and death. On February 17, 2008 CBS News 60 Minutes reported how manufacturer Bayer conducted a Trasylol study lead by a prominent Harvard physician and deceptively kept the negative research findings from the FDA and the unsuspecting public, delaying the recall in an effort to boost sales and dominate the cardiac surgery market. Bayer knew of Trasylol serious adverse health effects long before the recall, and reported nothing for more than two years, during which time its estimated that the drug contributed to the loss of one thousand lives a month.

Kidney Damage or Kidney Failure

Bayer AG removed Trasylol (aprotinin) from the market worldwide after studies revealed that the drug can cause kidney damage, kidney failure and cardiovascular side effects. Trasylol is used to control bleeding during heart bypass surgery and other serious surgical procedures. Because the drug is administered intravenously and after anesthesia, most patients do not know if Trasylol was used during their surgery. The complications associated with Trasylol has led to an increased risk of death in patients receiving Trasylol versus older, less expensive medications. One researcher estimated that at many as 22,000 could have suffered fatal side effects as a result of Trasylol.

In 2006, Dr. Dennis Mangano, an eminent medical researcher, completed a study that followed more than 5,000 patients, the largest Trasylol study every conducted. The study showed an important association between the drug and kidney failure requiring dialysis. In early 2006, Mangano presented his study to the FDAs advisory committee, but it was not embraced wholeheartedly because the study looked at hospital records of real-world patients, and was not a clinically controlled experiment testing Trasylol against a placebo.

At the same time, Bayer was holding the results of its own study, led by Alexander Walker of Harvard, with much of it concurring what Dr. Manganos study had already shown. Bayer representatives stood before the advisory committee and did not reveal that their study and negative findings even existed. A member of the FDA advisory committee, Dr. William Hiatt told 60 Minutes that had he known about Bayers study at that first meeting, he would have voted to take Trasylol off the market.

In 2007, the Canadian government conducted its own large clinical trial of Trasylol, but the study had to be stopped because patients in the study group were dying as a result of taking Trasylol. When the study was halted, Germany banned Trasylol, and both Canada and the FDA persuaded Bayer on November 5th, 2007 to pull worldwide sales of Trasylol.

There were concerns about Trasylol even before it go FDA approval in 1993. In the early 1980s, Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, the hometown of Bayer no less, found severe kidney damage in animals given Trasylol. He reported his findings to Bayer, but felt the manufacturer was not interested in examining these side effects. Soon after, the same side effects were being seen in patients in America.

In 1992, a small study was conducted, not funded by Bayer, in which Trasylol was given to 20 patients. Thirteen of these patients had problems with kidney failure after the procedure, a definite red flag. Safety concerns are often hard to assess until thousands of patients have been given the drug. But since Bayer never paid for any studies to determine whether there was a kidney failure problem, and their research did show that Trasylol controlled bleeding, the FDA approved it in 1993.

Bayer has marketed the drug aggressively, getting the FDA in 1998 to expand its approval to cover all heart bypass patients. It is estimated that by 2005, nearly 1/3 of all cardiac surgery patients were being given Trasylol, totaling nearly $300 million in sales annually.

Do You have a Trasylol Case?

If you believe that you or a loved one has suffered kidney damage, kidney failure, or a personal injury or has been adversely affected by Trasylol, please fill out the form below. There is no charge for this Trasylol case evaluation. An attorney from the Stenger Law Firm, LLC will review your information and contact you immediately.