Aprotinin Injection (marketed as
Trasylol) Information
[UPDATE 5/14/2008]: 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, the manufacturer of Trasylol (aprotinin),
notified the FDA of their intent to remove all remaining supplies of
Trasylol from hospital pharmacies and warehouses. [See FDA Statement].
Because Trasylol has been shown to decrease the need for red blood
cell transfusions in patients undergoing coronary artery bypass
surgery, future supplies of Trasylol will continue to be available
through the company as an investigational drug under a special
treatment protocol. In November 2007, Bayer suspended the marketing
of this drug until final results of the BART study became available.
The BART study showed an increase in the risk of death with Trasylol
compared with aminocaproic acid and tranexamic acid, consistent with
findings from other recent studies. FDA will be reviewing these data
and will reassess the status and access to the product once the review
is completed.
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FOR IMMEDIATE RELEASE
May 14, 2008
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Media
Inquiries:
Peper Long, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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Manufacturer Removes Remaining Stocks of Trasylol
Access Limited to Investigational Use
Background: On Nov. 5, 2007, the U.S. Food and Drug Administration 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 compared to two other drugs used to control bleeding.
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company
will begin removing the remaining Trasylol stock from the U.S. market, most
of which is in warehouses and hospital or physician’s stock. The FDA
will work with Bayer to ensure a smooth and complete process.
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.
FDA limits access to certain drugs to patients with serious or immediately
life-threatening disease or conditions who lack other therapeutic options and
may benefit from such therapies. This type of access requires the submission
of a protocol, which is reviewed and approved by the agency. Bayer has agreed
to provide Trasylol through this mechanism for the limited use described above.
Trasylol is an antifibrinolytic drug approved to reduce blood loss during
surgery and the need for blood transfusion in certain patient undergoing cardiopulmonary
bypass in the course of coronary artery bypass graft surgery. Antifibrinolyitc
drugs help slow the breakdown of blood clots and subsequent excessive bleeding.
Results from a randomized Canadian study that prompted last November’s
marketing suspension of Trasylol are expected to be published this week. The
data contained in this article suggest that Trasylol appears to increase the
risk for death compared to two other antifibrinolytic drugs used in the study.
The findings from this 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. This recently published Canadian study helps address
this need for additional information.
The FDA has not yet received full study data from the study’s researchers
at the Ottawa Health Research Institute but supports Bayer’s decision
to completely remove Trasylol from regular use in the U.S. market. FDA is also
reviewing the available Canadian study data to reassess the currently active
special treatment protocol that provides access to Trasylol.
FDA oversight requires comprehensive and thorough studies of a drug not only
during the pre-market review phase but throughout the drug’s life cycle.
As studies and data on Trasylol emerged over the years, FDA actions included
labeling changes, safety communications to physicians and other health care
professionals, public discussion and review of study data at two Advisory Committee
meetings, as well as close scrutiny of the ongoing studies.
The agency will consider a variety of study designs to support the review
process for future antifibrinolytics, and will incorporate into these considerations
information from the recently published Canadian study. FDA will continue to
publicly disseminate safety information.
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Additional Information
Feb. 8, 2006—FDA Press
Release on Public Health Advisory for Trasylol
Sep. 29, 2006—FDA Statement
Regarding New Trasylol Data
Dec. 15, 2006—FDA Press
Release Announcing Trasylol Label Changes
Oct. 25, 2007—FDA Early
Communication on Trasylol Safety
Nov. 5, 2007—FDA Press
Release Announcing Marketing Suspension of Trasylol
Treatment
Use of an Investigational New Dug—21 Code of Federal Regulations
