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
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