Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.
May 14, 2008
FDA.gov
Trasylol (aprotinin injection)
Audience: Cardiac surgeons and other healthcare
professionals [UPDATE 05/14/2008] Following publication of the Blood conservation using
antifibrinolytics: A randomized trial in a cardiac surgery population (BART)
study in the May 14, 2008 online issue of The New England Journal of Medicine,
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining
supplies of Trasylol from hospital pharmacies and warehouses. Under a limited
use agreement, access to Trasylol is limited to investigational use of the
drug according to the procedures described in a special treatment protocol.
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.
[Posted 11/05/2007] FDA announced that, at the agency's request, Bayer Pharmaceuticals
Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection),
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.
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. However, 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. 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.
[May 14, 2008 - Drug
Information Page - FDA]
[May 14, 2008 - FDA
News - FDA]
[November 5, 2007 - FDA
News - FDA]
Previous MedWatch Alert:
[October
25, 2007]
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