Study Pushes Anti-Bleeding Drug off Market

May 27, 2008

A new study conducted by the Ottawa Health Research Institute provides solid evidence that patients taking the anti-bleeding drug Aprotinin (marketed under the name of Trasylol) are at higher risk of dying from post-surgery complications then those receiving cheaper generic medications.

More than 2 thousand patients from 19 heart-surgery institutions of Canada took part in the research. The findings indicate that patients receiving Trasylol were 50% more likely to die from complications than those who took two other clotting medications (Amicar or Cyklokapron). 6% of the patients receiving Trasylol died within 30-day mark after the surgery. The reason for such high death rates, however, remains unrevealed. Researchers put the blame on the clotting properties of Trasylol.

According to the co-author of the research Dr. Paul Hebert, the risk of Trasylol outweighs its benefits. Trasylol (manufacturer Bayer AG) is used to prevent excessive blood loss during high-risk heart surgeries. The drug was first approved by the FDA (U.S. Food and Drug Administration) in 1993.           

Findings of several previous studies suggested that the drug can lead to an increased risk of heart attacks, strokes and kidney problems. As a result of these trials Bayer was forced to temporarily suspend the sales of Trasylol waiting for the outcome of further investigation into the safety of the medication. However many experts believe that the drug will stay off the market and won’t be used in heart surgeries.  

Numerous lawsuits were filed against Bayer claiming that the company was well aware of the danger and concealed the evidence. More than 200 thousand patients were given the drug in 2006 alone. FDA now waits for the details of the Canadian research to decide whether to allow using Trasylol in medical trials.  

According Dean A. Ferguson, blood transfusion expert and leading researcher at the Ottawa Health Research Institute, the findings of the study clearly indicate that the drug should not be used in lower-risk surgery.

The major alternatives to Trasylol arre tranexamic acid (marketed by Pfizer as Cyclokapron) and aminocaproic acid, (marketed by Xanodyne under the brand name Amicar) proved to both safer and cheaper. The costs of Trasylol treatment go as high as $1,500 while the two other drugs will require just $150. Taking into account that more than 1 million heart surgeries are performed annually, this is a major saving without safety compromises.

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