Safety monitoring of a polyvalent immunoglobulin preparation: documentation of 15,548 administrations.
Between 1997 and 2002, a post-marketing surveillance study was conducted throughout Germany to evaluate Intraglobin F in a replacement therapy for primary and secondary immunodeficiency diseases. A total of 15,548 individual administrations in 1,705 patients were documented.


METHODS
The study was conducted as a multicenter project involving 72 outpatient and inpatient treatment centers in Germany. The study variables were recorded during the routine treatment of patients with congenital or acquired immunodeficiencies. No additional variables outside the normal routine were recorded as is mandatory in post-marketing surveillance studies.


RESULTS
The rate of adverse drug reactions (ADR) was 0.064% in 15,548 administrations or 0.59% with reference to 1,705 treated patients; eight non-serious adverse events (AE) were considered to have a "probable" and one further AE a "possible" causal association with the use of Intraglobin F. Only one AE assessed as "serious" was classified as "probably" treatment-related. The efficacy of Intraglobin F was rated by the treating physicians as "very good" or "good" in 91.8% of the evaluated patients.


CONCLUSIONS
This post-marketing surveillance study has demonstrated the safety of Intraglobin F. The statistical results obtained with the data are supported by the overall assessment of the treating physicians who rated the tolerability of Intraglobin F as "very good" or "good" in 98.5% of the patients. No new or unexpected risks were observed.
Struff
W G
WG
German Red Cross Blood Transfusion Service, Institute Münster, Sperlichstrasse 15, 48151 Münster, Germany. w.struff@bsdwest.de
Klasser
M
M
Eckert
V
V
Dietrich
R L J
RL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D005260:Female; D005858:Germany; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data
D016756:Immunoglobulins, Intravenous