Trasylol Recall: Risk of Kidney Failure and Death for Heart Surgery Injection

After initially issuing a temporary withdrawal of their heart surgery drug in November, Bayer AG has now indicated that they will be removing the remaining supply of Trasylol from all U.S. markets. The announcement comes after the release of a study Wednesday by the New England Journal of Medicine which found that the use of Trasylol (aprotonin) increased the risk of death by 54% when compared with cheaper alternative drugs.

The study was stopped in October 2007, after preliminary results found a higher death rate among users of Trasylol. Approximately 2,300 individuals who were at a high risk for bleeding during heart surgery, or those with multiple health problems, were randomly assigned to groups which received Trasylol, or one of two alternative drugs to control bleeding. According to the final analysis, six percent of those treated with Trasylol died within 30 days of surgery, compared with four percent for those treated with other drugs.

At the request of the FDA, Bayer agreed to temporarily withdraw Trasylol in November 2007 once the preliminary data from the study was reviewed. However, now that the full analysis has been released, a Trasylol recall has been issued to remove any remaining supplies of the heart surgery injection.

Limited access to Trasylol will still remain possible under a very strict protocal which only allows the drug to be used where doctors can verify that the benefits of the drug clearly outweigh the risks. The protocol only allows doctors to use it where one of the alternative medications can not be used and the patient is at an increased risk of blood loss and transfusions during bypass surgery.

Bayer faces at least 78 Trasylol lawsuits filed by heart surgery patients who were given the aprotinin injection to control bleeding and subsequently suffered kidney failure, a heart attack, stroke or death.