Answers
02/25/1994

<TITLE>IMMUNE GLOBULIN INTRAVENOUS REMOVED FROM WORLD MARKET</TITLE>
<PRE>

T94-14                                       Lawrence Bachorik
Feb. 25, 1994                                James O'Hara
                                             (301) 827-6242

      IMMUNE GLOBULIN INTRAVENOUS REMOVED FROM WORLD MARKET

     FDA has been receiving inquiries about an action by Baxter
Healthcare Corporation to remove an immune globulin intravenous
(IGIV) product, Gammagard‘, from the market.  This product is also
distributed as Polygam‘ by the American Red Cross.  The following
may be used to answer questions. 
     The Hyland Division of Baxter Healthcare Corporation,
Glendale, Calif., has announced, as a precautionary measure, the
removal of its IGIV products from the world-wide market because of
their possible implication in the transmission of hepatitis,
including hepatitis C.  
     Baxter has recently reported that three patients in Spain and
two in Sweden have been found to have hepatitis C virus (HCV)
infection after receiving the firm's IGIV product.  Additional
patients have evidence of hepatitis and remain under study.  
     On the basis of the temporal association with product
administration, FDA regards these cases as potentially having
resulted from administration of the IGIV.  No case of viral
transmission from this product has been confirmed.  
     FDA is monitoring Baxter Healthcare's efforts to identify
implicated lots of the product and to analyze the laboratory and 
                             -MORE-

                       Page 2, T94-14, Immune Globulin Intravenous
clinical evidence of infection in the affected patients after use 
of IGIV.  
     Baxter's IGIV products are derived from human blood plasma and
are used to treat a number of congenital and acquired immunological
abnormalities.  In contrast, a different product, intramuscular
immune globulin, is used to help prevent hepatitis A in travelers
and for other conditions.  There are also specific immune
globulins, which are used for more specific medical purposes, such
as prevention of Rh sensitization, tetanus or rabies.  None of
these products is affected by this action.  
     All donors of plasma that is used to manufacture injectable
products for treatment and prevention of disease are screened to
exclude infection with five blood-borne disease agents, including
hepatitis C, hepatitis B and human immunodeficiency virus (HIV, the
AIDS virus).  
     No case of HIV transmission through immune globulin products 
-- whether for intravenous or intramuscular use -- has ever been
documented.  The cases reported by Baxter are the first cases of
hepatitis associated with licensed IGIV, although a few cases of
hepatitis C previously had been linked to unlicensed IGIV products
given during clinical trials.  
     Even though viral infections such as AIDS have never been
causally linked to the administration of these or other licensed
immune globulin products, as an extra precautionary measure FDA has
been working with all manufacturers to ensure that they develop and
adopt viral inactivation processes for these products.    
                              ####
</PRE>