New Trasylol Trial Halted Due to Deaths

Washington, DC: On March 27, 2008 Bayer AG said that a new trial on Trasylol had to be halted because the risk of death increased due to excessive bleeding. In addition to this new trial, previous studies have shown that Trasylol has a strong link to kidney failure in patients administered the drug when undergoing heart bypass surgery.

In 1993, the FDA approved Trasylol for use. In 2006, a study conducted by Dr. Dennis Mangano showed results that suggested Trasylol was indeed responsible for kidney failure in patients. His findings were presented to the FDA, but the FDA did not perform any actions against the drug until results withheld from them by Bayer AG were finally presented to them and showed the same results as Mangano's study. This withheld study included 67,000 hospital records that suggested Trasylol was associated with an increase in death from stroke, congestive heart failure, and kidney failure.

Other studies that have been conducted since then have showed an increased risk of kidney failure, stroke, and heart failure, which prompted the FDA to suspend the drug in November 2007. However in some medical facilities, Trasylol remains on the shelves and some doctors still choose to use it. Because of this continued use, the FDA issued a notice on its website on March 27 for doctors to be aware of the data that is suggesting an increased mortality risk.

The notice says that the 30-day mortality risk in those given Trasylol during the trial showed statistical significance when compared to the other drugs that were also tested alongside it. The findings showed that the bleeding itself was reduced, but that the increase in deaths was a result of hemorrhaging.

The FDA says that it will reevaluate the safety of the drug in order to go forth with certain regulatory actions such as label changes, warning of the risks associated with the drug. In February, the FDA advisory panel made the recommendation that Trasylol remain on the market despite the risks that are associated with it such as kidney failure, stroke, heart failure, and now bleeding. But the FDA had urged Bayer to conduct a clinical trial that is randomly-controlled. As a result of this trial, this new bleeding risk was found.

This new finding is rather ironic in that the drug was developed for the purpose of reducing bleeding during surgery, which was to eliminate or reduce the need for blood to be given to those patients with an increased risk of blood loss. It is estimated that one third of all patients who received heart bypass surgery had been given Trasylol since its 1993 FDA approval.

By Ginger Gillenwater