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Embroiled in controversy, Bayer Pharma has decided to remove the remaining stock in hospitals of its anti-bleeding medication Trasylol. The reasons, Bayer AG claims, is because of the response from studies that show it nearly doubled the death rate when compared to lower-cost alternative medications that were already established in the market.

Dual studies in Canada and America have cited that the drug, called also aprotinin, is more dangerous during heart surgeries than other medications. It is estimated that tens of thousands of lives could have been saved had the doctors or hospitals not chosen Trasylol.

Trasylol treatment costs over $1,250 USD compared to other medication alternatives that were $150 per dose, which calls into question whether Bayer was, in addition to producing a defective medication, gouging prices from those who were administered Trasylol.

The drug was known, or at least implicated, to have issues as far back as 2006, where Trasylol caused increased death rates, kidney failure or even stroke. Despite this, Bayer was granted FDA approval for Trasylol.

“These three drugs have been routinely used in heart surgery for more than a decade, but this is the first trial to rigorously compare them in a meaningful setting with meaningful clinical outcomes,” Fergusson said in a statement. “The results demonstrate the great value of and the need for independent academic clinical trials.”

Cardiac arrest and cardiogenic shock were common fatalities when people were given Trasylol for open heart surgery. Bayer claims it will continue to work with the FDA to figure out, “what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol.”

One thing is certain, Trasylol lawsuits from the families of those affected by the drug’s side-effects will be filed soon, and a Trasylol class-action lawsuit can not be far off.

http://www.sciam.com/article.cfm?id=bayer-pulls-trasylol-supp

Source: Scientific American

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