FDA Requests Marketing Suspension of Trasylol
FDA.gov (Source link: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01738.html)
November 5, 2007
The U.S. Food and Drug Administration (FDA) today announced
that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to
a marketing suspension of Trasylol, a drug used to control bleeding during
heart surgery, pending detailed review of preliminary results from a Canadian
study that suggested an increased risk for death.
FDA requested the suspension
in the interest of patient safety based on the serious nature of the outcomes
suggested in the preliminary data. FDA has not yet received full study data
but expects to act quickly with Bayer, the study's researchers at the Ottawa
Health Research Institute, and other regulatory agencies to undertake a thorough
analysis of data to better understand the risks and benefits of Trasylol.
There
are not many treatment options for patients at risk for excessive bleeding
during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol
out of the marketplace in a way that does not cause shortages of other
drugs used for this purpose.
Until FDA can review the data from the terminated
study it is not possible to determine and identify a population of patients
undergoing cardiac surgery for which the benefits of Trasylol outweigh the
risks. Understanding that individual doctors may identify specific cases
where benefit outweighs risk, FDA is committed to exploring ways for those
doctors to have continued, limited access to Trasylol.
Two weeks ago, FDA
was notified that researchers with the Ottawa Health Institute stopped
a study on Trasylol because the drug appeared 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 subsequent excessive bleeding.
The preliminary data from this terminated study also suggested that fewer
patients receiving the drug experienced serious bleeding events.
On Oct.
26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol
in response to the Canadian study's termination. In 2006, FDA revised the
labeling for Trasylol to strengthen its safety warning and limit its approved
usage to patients at an increased risk for blood loss and blood transfusion
during coronary bypass graft surgery.
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