July 19, 2005
FOR IMMEDIATE RELEASE
MEDIA INQUIRIES:  301-827-6242
CONSUMER INQUIRIES:  888-INFO-FDA
P05-43


        FDA Issues Public Health Advisory for Mifepristone
       
        The Food and Drug Administration (FDA) is investigating
recently reported serious adverse events associated with mifepristone (trade
name Mifeprex, also known as RU-486).  As a result, the FDA is issuing a
public health advisory today highlighting the risk of sepsis or blood
infection when undergoing medical abortion using Mifeprex and misoprostol in
a manner that is not consistent with the approved labeling.  There are now
four cases of deaths from infection from September 2003 to June 2005
following medical abortion with these drugs.
       
        "The FDA is committed to sharing emerging drug information
with the public and we believe it is important to share with healthcare
providers and patients the latest serious reports of infection associated
with this drug that we have received," said Dr. Steven Galson, Acting
Director of FDA's Center for Drug Evaluation and Research.
       
        The bacteria thought to have caused the fatal infection have
been identified in two of the cases and the other two cases are under
investigation by FDA along with the Centers for Disease Control and
Prevention, State and local health departments, and the manufacturer of
Mifeprex.  Doctors are urged to have a higher level of suspicion for sepsis
in their patients taking Mifeprex. 
       
        Previously, the FDA has received reports of serious
bacterial infection, bleeding, ectopic pregnancies that have ruptured, and
death.  Those reports led to the revision of the black box labeling.
Mifeprex was approved by the FDA in 2000.
       
        For more information, please go to
http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm