Bayer Removes Remaining Trasylol Stock

Background: On Nov. 5, 2007, the Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death in patients taking Trasylol compared to two other drugs used to control bleeding.

Bayer HealthCare Pharmaceuticals Inc. has notified FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and in hospitals' and physicians' stock. FDA will work with Bayer to ensure a smooth and complete process.

Drug Limited to Investigational Use
Access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment study plan (protocol). This type of access requires the submission of a protocol, which is reviewed and approved by FDA.

The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.

Study Results
Results from a randomized Canadian study that prompted last November’s marketing suspension of Trasylol suggest that Trasylol appears 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 excessive bleeding.

The findings from the randomized study are similar to those from an observational study that was discussed at a September 2007 FDA advisory committee meeting. Based upon the data available at the time, the advisory committee recommended continued marketing of Trasylol. However, FDA requested the marketing suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data.

The committee also advised that a large, randomized clinical study was needed to further assess Trasylol’s safety compared to other drugs. The Canadian study helps address this need for additional information.

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01834.html

Marketing Suspension of Trasylol for Heart Surgery
http://www.fda.gov/consumer/updates/trasylol110507.html

Date Posted: May 16, 2008