FDA, Bayer Announce Suspension of Trasylol that Is Used In Heart Surgeries

The U.S. Food and Drug Administration announced that Bayer Phamaceuticals Corporation was suspending marketing and sales of Trasylol. This was done at the request of the FDA. The drug is used during heart surgery to control bleeding, and will be suspended until there is a review of results from a study conducted in Canada. The study suggested an increased risk of death when the drug is administered.

To insure patient safety, the FDA requested a suspension of Trasylol sales because the preliminary data in the study was cause for concern. The full study data has not been delivered to the FDA as of yet, however when it comes the FDA will go over the date with the researchers and Bayer to better understand the information.

Excessive bleeding while having heart surgery is not a condition with a lot of treatment choices. Bayer will pull Trasylol out of use slowly to insure that there are no shortages of other medications that can be used for excessive bleeding.

Ottawa Health Institute, the company that performed the study, stopped the research on Trasylol when it became apparent that the drug was causing an increased risk of death. The other antifibrinolytic medications in the study were not creating near as much risk. The purpose of antifibrinolytic medication is to slow the breakdown of blood clots and as a result stop excessive bleeding. However, the data, before the study was terminated, was showing improved results from the Trasylol medication as compared to the other drugs.

There might be instances where the positive results from Trasylol will outweigh the possible risk; however, until the FDA can look at all the data, that cannot be determined. The FDA will try to work with medical personnel to find ways for them to have access, although limited, to Trasylol.