Trasylol - Aprotinin Injection

RSS
Modified on 2010/09/13 07:47 by Chrissie Cole
trasylol - aprotinin - warning marketing suspended

trasylol - aprotinin - warning marketing suspended


Trasylol History

August 2010

In August, Bayer agreed to pay $60 million to settle 150 [http://www.businessweek.com/news/2010-08-17/bayer-said-to-pay-60-million-to-settle-trasylol-lawsuits.html|lawsuits over Trasylol\. The settlements provide an average payout of about $400,000 per patient.

The company currently faces about 1,600 lawsuits involving similar allegations that the drug maker failed to exercise the proper degree of care in designing and testing the drug.

May 2008

After the BART study on antifibrinolytics was published in the New England Journal of Medicine on May 14, 2008, Bayer Pharmaceuticals announced to the FDA that the company was withdrawing all outstanding Trasylol supplies in global markets. This development emerged after heated debate over whether the efficacy of the drug outweighed its serious side effects.  Several physicians have made allegations that the drug's medical use to reduce blood loss during surgery has resulted in patient deaths.  The drug was supended from use temporarily in November 2007 when a preliminary study on Trasylol's use demonstrated dramatic clinical side effects.    

November 2007

On November 5, 2007 the FDA issued a marketing suspension for the anti-bleeding drug Trasylol.  Trasylol (aprotinin injection) is approved for use in cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery.  The drug has been approved for use since December of 1993.  It has been used in surgeries around the world.  The FDA is investigating reports that 235 people died in the United States after receiving Trasylol in surgeries from 1993 to February 2006.

The marketing suspension was issued after the Blood Conservation using Antifibrinolytics in a Randomized Trial (BART) was suspended early after test data showed that Trasylol increased the risk of death by 50 percent compared to two other drugs in the same class.  The BART study was performed by researchers at the Ottawa Health Research Institute.  The study analyzed data from over 3,000 cardiac surgery patients since 2002.  The results were so drastic that the study was halted, and no new patients were enrolled pending further analysis.  Trasylol has been linked to an increased risk of kidney failureheart attack and stroke.   

The BART studied prompted the removal of Trasylol from countries around the world.  The European Union, Great Britain, China and many other counties all joined the United States in the marketing suspension.  The FDA has recommended that surgeons weigh carefully the use of existing stock of Trasylol on high risk patients. 

View the latest information from the FDA about Trasylol.

October 2007

The FDA is advised by the Data Safety Monitoring Board (DSMB) that a Canadian study has stopped enrolling patients for the Trasylol portion of the BART study.  Early analysis of the data has shown that patients on which Trasylol was used have an increased risk of death.  Further analysis of all of the data is expected.

February 2007

The Journal of the American Medical Association (JAMA) published a report on a long term study of the side effects of Trasylol after cardiac surgery.  It analyzed data from 4374 patients for up to five years post-surgery.  The report concluded that the risk of using Trasylol outweighed the benefit.

December 2006

The FDA revised the labeling on Trasylol to include a stronger safety warning and greater limitations on the conditions for use.  Trasylol is now only approved for use during coronary bypass graft surgery with the use of cardiopulmonary bypass to reduce the amount of blood loss.  The labeling now includes a warning that there is an increased risk of kidney failure following the use of Trasylol.

September 2006

The FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee in order to talk about the anti-bleeding drug Trasylol.  At issue were studies showing Trasylol may increase the risk of kidney failure, heart failure and strokes in patients following cardiac surgery.  Following the meeting Bayer reported to the FDA that they had results from another study on Trasylol.  This study preliminarily showed that the risk of death was increased when using Trasylol.   

February 2006

A Trasylol Public Health Advisory was issued by the FDA following two studies that reported the risk of kidney failure, heart attacks and strokes was increased following the use of Trasylol in cardiac surgery.  Doctors were cautioned to only administer Trasylol to the patients most at risk of blood loss and to carefully monitor them post surgery for serious side effects.

Drug Injury

It is important to obtain your medical records from your doctor to learn if Trasylol was used during surgery.  Trasylol has been used in surgeries that are not on the FDA approved use for Trasylol, such as heart valve replacement surgery. 

For more information about drug injuries, please see our FDA and Prescription Drug help center.

  Name Size