Trasylol Lawsuit

If you or a loved one have recently undergone heart surgery, you may have been administered a drug called Trasylol, also called Aprotinin, which is administered to reduce blood loss during the procedure. If you or a loved one suffered from kidney failure, stroke or heart attack after having cardiac surgery, it is possible that Trasylol was the culprit.

Recent studies have reported that Trasylol significantly increases the risk of kidney failure, stroke and heart failure in patients administered the drug. The first of these studies, published in the New England Journal of Medicine in January of 2006, reported that Trasylol doubled the risk of kidney failure post operatively and also significantly raised the chance of stroke, heart failure, and heart attack. The study also found that two cheaper alternative drugs were equally as effective as Trasylol, without the dangerous side effects

In order to assess these risks more fully, the Food and Drug Administration (FDA) initiated hearings on whether the drug label for Trasylol should be expanded to include these risks. In September of 2006, the FDA decided no label changes were necessary.

Less than one week later, the FDA was alerted that Bayer, the manufacturer of Trasylol, had withheld information regarding a study being conducted at Bayer’s request. Bayer later admitted intentionally withholding that study from the FDA Committee, but argued that it was just a mistake. The FDA then warned doctors across the country that Trasylol may be associated with an increased risk in heart attack, kidney failure, and stroke.

In December of 2006, the FDA changed the warning label for Trasylol to reflect these new dangers.

More recent studies have confirmed the adverse renal effects of Trasylol, as well as revealed an association between Trasylol use and an increase in patient deaths. In October of 2007, a study designed to compare the efficacy of Trasylol with cheaper alternatives was shut down because Trasylol increased the risk of death. Finally, on November 5, 2007, the FDA forced Bayer to suspend marketing of Trasylol. At a press conference that day, the FDA stated that it could not identify a patient population in which the use of Trasylol outweighs the risk.

In an interview with 60 Minutes, one prominent medical researcher estimated that as many as 22,000 deaths could have been prevented if Trasylol was taken off the market immediately following the initial studies in January of 2006.

Plaintiffs contend that even though the risks of death and kidney failure were known to Bayer, it failed to warn the public or physicians about these serious complications. Fleming and Associates is actively investigating additional cases involving Trasylol has suffered from kidney failure and/or death following heart surgery.