Bayer Pulls Remaining Stocks Of Trasylol

Featured Article
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cardiovascular / Cardiology;  Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 15 May 2008 - 2:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The US Food and Drug Administration (FDA) announced yesterday, Wednesday 14th May, that Bayer Pharmaceuticals Corporation is withdrawing remaining stocks of its antifibrinolytic drug Trasylol (aprotinin) following the confirmation of the preliminary findings of a study that showed the drug increased risk of death compared to two other drugs used to control bleeding during heart surgery.

Back in October and November last year, the FDA announced that Bayer had agreed to an FDA request to suspend marketing of Trasylol, after the preliminary findings of the Canadian study, known as BART (Blood Conservation using Antifibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients) suggested it increased risk of death. The company said it would re-assess its options once the final results were available.

These results are now available and were published yesterday, 14th May, in the New England Journal of Medicine. They confirm the early findings, and conclude that although aprotinin (brand name Trasylol) reduces bleeding modestly, its high mortality rate compared to two other antifibrinolytic drugs "precludes its use in high-risk cardiac surgery". The two other antifibrinolytic drugs were the lysine analogues tranexamic acid and aminocaproic acid.

Drs Wayne A Ray and C. Michael Stein from Vanderbilt University in Tennessee wrote in an accompanying editorial that:

"Thus, in all likelihood, this is the end of the aprotinin story."

Bayer has informed the FDA that it will now remove remaining stocks of Trasylol from the US market. Most of the stock is in warehouses, doctors' surgeries, and hospitals. The agency said it will work with the drug company to ensure a "smooth and complete process".

The drug remains available for investigational use, under the control of a limited use agreement and a treatment protocol that has to be approved by the FDA. Bayer has agreed to provide the drug under these conditions.

This means Trasylol will be available for certain patients who have no other treatment options for reducing their high risk of blood loss and transfusion during coronary artery bypass graft surgery. The FDA said doctors should make sure the benefits of Trasylol "clearly outweigh the risks" if they use it with their patients.

Trasylol belongs to a class of drugs known as antifibrinolytics because they slow the breakdown of blood clots and therefore reduce excessive bleeding. It was approved by the FDA in 1993 to reduce blood loss and the need for transfusion in patients having a cardiopulmonary bypass during coronary artery bypass graft surgery.

At the time of the announcement yesterday, the FDA had not yet received the full results of the BART study, but said it supported the company's decision to pull the drug from the US market. When it receives the full results, the agency will also review the details of the current special treatment protocol for the drug because that will control the limited use for certain patients in the future.

"A Comparison of Aprotinin and Lysine Analogues in High-Risk Cardiac Surgery."
Fergusson, Dean A., Hebert, Paul C., Mazer, C. David, Fremes, Stephen, MacAdams, Charles, Murkin, John M., Teoh, Kevin, Duke, Peter C., Arellano, Ramiro, Blajchman, Morris A., Bussieres, Jean S., Cote, Dany, Karski, Jacek, Martineau, Raymond, Robblee, James A., Rodger, Marc, Wells, George, Clinch, Jennifer, Pretorius, Roanda, the BART Investigators.
N Engl J Med, Published online 14th May 2008.
DOI: 10.1056/NEJMoa0802395

Click here for the full Article.

Click here for FDA.

Sources: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today