Increased risk of wrongful death blamed on Trasylol drug

Anneke Kurt

Contributor

0 CommentsPrint ArticleSubscribe

A recent Canadian study showed that the drug Trasylol, used during heart surgeries to control bleeding, could cause an increased risk for wrongful death, according to the U.S. Food and Drug Administration. Bayer Pharmaceuticals Corp., the makers of Trasylol, have suspended sales and will slowly pull the drug off of shelves. Our Toledo, Ohio personal injury attorneys see the overwhelming effects that personal injury or wrongful death resulting from prescription drugs have on families, and encourage patients to ask their doctors questions and know what drugs they are taking before, during and after any surgery.

The following is an excerpt from the Food and Drug Administration website:

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.
Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.
On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

For more information on this subject, please refer to the section on Wrongful Death.