Trasylol

Trasylol Highlights

Trasylol used during surgery to control bleeding, fatal side effect is renal failure.
December 2006 FDA issues black Box warning.
May 2008 Trayslol pulled completely from the U.S. market.

Lawsuits and Investigations

About Trasylol

Trasylol, manufactured by Bayer Health Care, is a pharmaceutical drug used to reduce the bleeding associated with complex surgeries. Trasylol was approved by the FDA for surgical use in 1993. Also known as an Aprotinin Injection, Trasylol was widely used to reduce the need for blood transfusions during surgery and alleviate the risks associated with surgical blood loss.

If you or a loved one were injured after being administered Trasylol, you may be entitled to a cash settlement. Please complete the form and one of our attorneys will contact you or call 1-800-LAW-FIRM now.

In May 2008, Trasylol was completely removed from the United States market. Over time many patients who were given Trasylol suffered kidney failure and required dialysis after their surgery. In addition, other studies established that side effects associated with Trasylol significantly increased the risk of death.

According to a February 2008 report on CBS Television’s 60 Minutes, approximately 22,000 deaths could have been prevented between January 2006 and November 2007 if the Trasylol recall had been issued when information about the potentially fatal side effects first surfaced.

Conditions Caused By Trasylol

Acute Renal Failure (Presenting most commonly within 30 days of open-heart surgery.)

Side Effects & Symptoms

Death
Heart Attack
Heart Failure
Stroke
Encephalopathy

Warnings & Recalls

In September 2006, Bayer was faulted by the FDA for not revealing during testimony the existence of a commissioned retrospective study of 67,000 patients, 30,000 of whom received. The study concluded Trasylol carried greater risks than drugs prescribed for the same purpose.
In December 2006, the FDA issued a black box warning for Trasylol detailing the serious risks of renal failure and cardiovascular effects. Bayer temporarily suspended marketing and sales of the drug following this warning.
On November 5, 2007, Bayer announced that it was withdrawing Trasylol because of a Canadian study that showed it increased the risk of death when used to prevent bleeding during heart surgery.
In May 2008, following the completion of a study linking Trasylol to serious adverse side effects, Bayer informed the FDA it was pulling the remaining quantities of the drug from the United States marketplace. Trasylol is no longer available for sale in the United States.