A growing body of literature documents that intravenous immunoglobulin prop
hylaxis and therapy is becoming applied to a steadily growing list of new i
ndications. Some of these new indications have led to the use of intravenou
s immunoglobulin therapy in doctors offices, far from the hospital environm
ent. Being stable products purified from blood or plasma donations, intrave
nous immunoglobulins must be considered as biological products in addition
to their status as pharmaceutical products. This makes the study of adverse
reactions reach beyond a mere drug safety surveillance programme into the
realms of good manufacturing procedures guaranteeing not only intravenous t
olerance but also sterility with regard to transfusion transmitted agents.
The initially perceived adverse effects, stemming from complement activatin
g aggregated immunoglobulin G, had the effect Of slowing down widespread in
troduction of intravenous immunoglobulin therapy in the late 1970s, These a
dverse effects have now been eliminated with amendment of the appropriate m
anufacturing steps. However, new adverse effects, such as hyperviscosity, a
septic men-ingitis or renal insufficiency, have been observed which can be
assigned to certain compounds of intravenous immunoglobulin, to administrat
ion regimens or to special patient characteristics.
Adverse effects can be divided into 3 types: immediate adverse effects (tho
se that occur during the infusion, e.g. anaphylactoid reactions); delayed a
dverse effects (those that occur hours to days after initiation of the infu
sion, e.g. renal, pulmonary, dermatological adverse effects, hyperviscosity
, aseptic meningitis, arthritis, cerebral infarction, haemolysis and leucop
enia) and; late adverse effects (e.g. transmission of infectious agents).
We conclude from our analysis, that in general, intravenous immunoglobulin
may be considered a well tolerated medical agent provided the indication fo
r use is chosen carefully and use is monitored by a physician familiar with
contraindications, risks, adverse effects and their appropriate management
.