Adverse effects of intravenous immunoglobulin therapy

Citation
Ue. Nydegger et M. Sturzenegger, Adverse effects of intravenous immunoglobulin therapy, DRUG SAFETY, 21(3), 1999, pp. 171-185
Citations number
73
Categorie Soggetti
Pharmacology
Journal title
DRUG SAFETY
ISSN journal
01145916 → ACNP
Volume
21
Issue
3
Year of publication
1999
Pages
171 - 185
Database
ISI
SICI code
0114-5916(199909)21:3<171:AEOIIT>2.0.ZU;2-R
Abstract
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 .