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FDA Did Not Certify Trasylol as Safe

Los Angeles, CAThose who did not know what Trasylol was six months ago are probably aware of what it is now. For those who don't know, it is an anti-bleeding drug used during heart bypass surgery since 1993 that was taken off the market in November 2007 because of a link found between use of the drug and kidney failure in patients who received it.

There are approximately 63 cases that have been filed against Bayer AG, the drug's manufacturer, for the death of loved ones or the injuries sustained by those administered it.

Trasylol SurgeryTrasylol was not approved by the FDA until 1993, but was being tested as early as the 1980s in which controversy regarding its safety was raised. Animals that were administered the drug were said by researchers to have experienced severe kidney failure. The doctor who conducted the experiment on the animals said that Bayer was not interested in taking another look at the drug when they were informed of the results of the animal tests. At that point, the drug company was making hundreds of millions of dollars off of it.

In 1992, before the drug was approved by the FDA, one of the nation's leading heart surgeons conducted his own study in which twenty people were administered Trasylol during their surgery. Of the twenty, thirteen of them had kidney problems following the procedure. When the FDA approved the drug in 1993, they did not approve it as being a safe drug. They approved it as being effective in controlling excess bleeding in bypass patients.

Not until 2006 had there been a large enough study to determine whether or not kidney failure was indeed an issue with Trasylol use, so Bayer nor the FDA had any reason to pull it from the shelves until Dr. Dennis Mangano made the claim that thousands had died because of the drug after conducting his own study. This claim led to the FDA advisory committee meeting eight months before the scheduled meeting that was to discuss Trasylol. Bayer had conducted its own study and found its results to be quite similar to those of Mangano's, but withheld the results from the September 2006 advisory committee meeting. Because the FDA didn't have the results of Bayer's study, Mangano's study was voted against and the drug was kept on the shelves for approximately 14 more months.

In February, Mangano was interviewed on the cable news show "60 Minutes" in which he claimed that approximately 22,000 lives could have been saved had the FDA not awaited the results of Bayer's study and removed it when Mangano's study became public. It is also suggested that Bayer knew of these adverse effects since 2002 and did nothing about it.

However, many allege that the reason why Bayer did not remove the drug from the market when it knew of the adverse side-effects is because of the significant financial loss the drug company would face if they removed it. One dose of Trasylol is believed to have cost approximately $1,000 compared to the alternatives that cost around $10 to $25 per dose and have no reported side effects.

On Trasylol's website, Bayer states that they believe the increased risk for kidney failure is associated with an already existing condition that these patients may or may not have been aware of. Currently, the drug is undergoing further testing to see if this claim is a possibility. In the meantime, the drug remains suspended from further distribution.



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