Answers 11/06/1987
T87-55
Nov. 6, 1987
AIDS/RhoGAM Update
The Food and Drug Administration and the Centers for Disease Control
have concluded that a plasma product called RhoGAM -- used to prevent an
uncommon condition of blood incompatibility in some pregnant women and their
unborn children -- did NOT cause a woman in the military and her child to be
infected with the AIDS virus (HIV).
The finding, which will be officially reported soon, was revealed in a
story in the San Diego Union today. The newspaper initially reported the
case and its possible link to the plasma product in September.
The woman does test positive for HIV antibody (but has not developed
AIDS.) However, FDA and CDC have concluded 1) that the alcohol
fractionation method used in preparing RhoGAM would inactivate any virus
that might be present, and 2) there are other, more likely sources of the
Aids virus, for this woman.
The agencies will not -- and cannot -- provide information in detail
since patient records are private.
The federal agencies recommend the resumption of RhoGAM's use by any
facility that might have been awaiting the result of the investigation.
(See also Talk Paper T87-41.) RhoGAM is an Rh Immune Globulin produced by
Ortho diagnostic Systems.