2008 ICES Study Provides More Evidence That Bayer's Trasylol Wasn't Safe

A new study by the Institute for Clinical Evaluative Sciences (ICES) in Toronto reveals that Bayer's Trasylol, an anti-bleeding drug which had been used in cardiac surgery, was riskier to use than alternative drugs. This is not good news for Bayer who has been accused of concealing the risks of Trasylol for years and faces hundreds of lawsuits.

What the new study says

According to news reports, the study conducted by the ICES's team of Canadian and Australian researchers reviewed 49 randomized trials comparing Trasylol to tranexamic acid or aminocaproic acid and included new information from an earlier clinical study (known as BART) conducted by the Canadian Data Safety Monitoring Board that had to be terminated because too many of the participants were dying.

The ICES found that Trasylol posed a higher risk of death for patients than similar drugs known as lysine analogues. The researchers were quoted as saying, "Compared with aprotinin [Trasylol], lysine analogues are almost as effective, are cheaper and do not appear to increase mortality." Results of the new study will be published in the January 20, 2009 edition of the Canadian Medical Association Journal.

Trasylol lawsuits

Hundreds of products liability lawsuits have been filed against Bayer since the pharmaceutical giant took the drug off of the market in November of 2007. The lawsuits allege that Bayer knew of the dangers of Trasylol for years - well before it was approved by the U.S. Food and Drug Administration (FDA) for use in the United States in 1993 - but failed to disclose the drug's dangers.

It wasn't until CBS aired a news report about Trasylol that the public became aware of the issue. Dr. Dennis Mangano, who published a study on the dangers of Trasylol in 2006, says that although Bayer knew about the dangers associated with drug, it failed to warn the public because of increasing profits from the drug's sale. Mangano says that had Bayer pulled Trasylol off the market after his study was published, over 20,000 patients' lives could have been saved.

Lawsuits against Bayer are not limited to the U.S. A Canadian law firm recently announced that it may be filing a class action lawsuit against Bayer for the injuries and deaths related to the drug's usage by Canadian citizens.

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