FDA requested Bayer stop sales of Trasylol injection

By Harvey Kirk
Posted November 5, 2007

ADD YOUR COMMENTS 1

The FDA announced today that they requested Bayer Pharmaceuticals halt further sales of Trasylol pending their review of data from a Canadian study which suggests that the heart surgery injection significantly increases the risk of death.  The injection has been under scrutiny from regulators for nearly two years as a result of findings that it increases the risk of serious and potentially fatal injuries.  The lawyers at Saiontz & Kirk, P.A. have been investigating potential Trasylol lawsuits since February 2006, and are continuing to review new claims.

>>INFORMATION: FDA Trasylol Notice

Trasylol, known generically as an aprotonin injection, was approved by the FDA in 1993.  It is administered before heart bypass surgery to reduce blood loss and avoid the need for a transfusion. 

In January 2006, a study published in the New England Journal of Medicine found that Trasylol side effects could double the risk of kidney failure and increase the risk of heart attacks, heart failure and strokes.  As a result of these findings, a “black box” warning was  added to the injection in December 2006 and sale have fallen sharply as doctors looked to safer alternatives for their patients.

Last month, Canadian researchers stopped enrolling new patients in a study designed to evaluate Trasylol after preliminary data found that there was a statistically significant increase in the risk of death at 30 days after use of the heart surgery injection.  In addition, while Trasylol was associated with less serious bleeding, more people who received the aprotonin injection died due to hemorrhage than those who received a different drug.

>>PRIOR POST 10/28/2007: Trasylol Death Risk

The temporary suspension of marketing requested today by the FDA was initiated because of the serious nature of the risk suggested by preliminary data from the Canadian study.  The FDA indicates that they have not yet received the complete data from the study, but that they will act quick to thoroughly analyze the benefits compared to the Trasylol death risk.

The Trasylol recall will remove the heart surgery injection from the market in such a way that it does not cause a shortage of supply for other drugs used to control bleeding during heart surgery.  In addition, the FDA may explore possible ways to have limited Trasylol use for situations where doctors identify specific cases where the benefits outweigh the risk of death and serious injury.

TRASYLOL RECALL LAWSUITS

The Trasylol lawyers at Saiontz & Kirk, P.A. represent several clients who have died or suffered serious injuries, such as kidney failure, heart attacks and death after receiving the heart surgery injection.  Many individuals are unaware that they were given a Trasylol injection before bypass surgery.  Therefore, potential cases are investigated to obtain medical records and determine whether injuries may be related to the use of aprotinin to control bleeding.

If you suspect that kidney failure, heart attack, stroke or death suffered by a loved one after cardiac bypass surgery may be related to an injection given before surgery to control bleeding, request a free consultation and claim evaluation.