Bayer Signals End Of Trasylol With Recall

Tuesday, June 3rd, 2008

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

Trasylol Anti-Bleeding Drug Proves High Surgery Death Risk

Thursday, May 15th, 2008

In November, Bayer pulled it’s anti-bleeding drug off the market due to reports from studies that it caused up to 22,000 deaths from people who were taking it. Now, a recent study’s results released on Wednesday confirms that Trasylol indeed is a definite risk to those who took it for its clotting properties when undergoing open heart surgery.

The New England Journal of Medicine released studies that an incredible 6% of those who took Traysol died within 30 days of their surgeries, and the drug itself increases a mortality rate of up to 50%. Compared to other medications that were used previously to Trasylol’s release, this is a death rate increase of 2%. This study proves that this next-generation medication actually does more harm than good for those undergoing surgical procedures.

Incredibly, this prescription medication for bleeding costs $1,400 per dose, or $1,390 more than the older, safer drug; bringing into question the company’s motives for releasing the drug so quickly into market and its reluctance to admit it’s fault.

While it is noncommittal to whether its medication will return to the market, Bayer is now fighting off 83 lawsuits related to Trasylol prescription drug usage with more likely to follow.

http://online.wsj.com/article/SB121080806023693335.html

Source: Wall Street Journal

Bayer Defends 78 Trasylol Lawsuits After Recall

Saturday, May 3rd, 2008

Now defending itself in 78 lawsuits since pulling Trasylol blood thinner from the shelves in November, Bayer is in a world of trouble.

After Canadian research found links between Trasylol and unnecessary deaths when using it for blood thinning, the FDA relented and agreed in September 2007 that the medication was in need of a recall. What makes this case worse is that Traysol was known, for years prior to its recall, to be a possibly deadly medication. According to a cited statistic, 22,000 lives may have been lost as a direct link to Trasylol use in open-heart surgeries.

In typical fashion of Big Drug manufacturers, Bayer responded by saying:

“the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.”

Bayer, it appears, will need an aspirin for this legal headache.

http://www.newsinferno.com/archives/2986

Source: NewsInferno

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