News
12/30/1993

<TITLE>Approval of Aprotinin</TITLE>
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P93-48                               Food and Drug Administration
FOR IMMEDIATE RELEASE                Susan M. Cruzan (301) 443-3285


     The Food and Drug Administration today announced approval of 
aprotinin, a drug that can reduce the need for blood transfusions
in patients undergoing heart bypass surgery.
     In l991, 265,000 coronary bypass graft operations were
performed to replace diseased blood vessels.  Excessive bleeding is
a frequent complication of this surgery.     
     Two placebo controlled clinical trials conducted in the United
States demonstrated that aprotinin effectively reduced blood loss
and decreased the need for transfusions.  In one study, 42 percent
of patients treated with aprotinin needed at least one unit of
blood, compared to 77 percent who did not receive the drug.  The
second study showed similar results.    
     Aprotinin was studied for use mainly in heart surgery because
the circulation of the blood outside the body in this surgery
increases the likelihood of excessive bleeding during and after
surgery.  Its use should be reserved for high risk patients,
however, because severe allergic reactions can result from using it
more than once in a patient.  Kidney toxicity was also a problem in
some patients in the trials. 
     "Aprotinin can reduce the risks of bypass surgery for some
patients,"  said FDA Commissioner David A. Kessler, M.D.  "Fewer
transfusions mean a much lower risk of infection or possible
adverse reactions to the blood." 
                             -MORE-
ATTENTION TV BROADCASTERS:  PLEASE USE OPEN CAPTIONING FOR THE    
                            HEARING IMPAIRED.

                                       Page 2, P93-48, Trasylol
     Aprotinin will be most useful in patients at high risk of
bleeding --  particularly patients undergoing repeat bypass surgery
or patients with clotting defects, for example.  The drug may also
be used in patients with rare blood types or in other cases when
access to blood is limited.   
     Miles Inc. of West Haven, Conn., will market aprotinin under
the name Trasylol Injection.  The company has agreed to conduct
further studies to evaluate the drug in other types of surgery
associated with a high risk of bleeding, such as organ transplants
and aortic reconstruction.   
     FDA is one of the eight Public Health Service agencies in HHS. 
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