Thromboembolic events associated with immunoglobulin treatment

Objective Due to an increasing number of reported thromboembolic events (TEE) after the administration of one intravenous immunoglobulin (IVIG) and one subcutaneous immunoglobulin (SCIG), pharmacovigilance and laboratory data were collected to analyse the root cause and assess the reporting frequenc...

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Bibliographic Details
Published in:Vox sanguinis 2013-07, Vol.105 (1), p.54-64
Main Authors: Funk, M. B., Gross, N., Gross, S., Hunfeld, A., Lohmann, A., Guenay, S., Hanschmann, K. M., Keller-Stanislawski, B.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Child
Correlation analysis
Data processing
Embolisms
Female
frequency
Humans
immunoglobulin - severity
Immunoglobulins
Immunoglobulins, Intravenous - administration & dosage
Immunoglobulins, Intravenous - adverse effects
Immunologic Factors - administration & dosage
Immunologic Factors - adverse effects
Immunotherapy
IVIG - corrective actions
Male
Middle Aged
NAPTT
pharmacovigilance
Retrospective Studies
Thromboembolic events
Thromboembolism - chemically induced
Thromboembolism - epidemiology
Thromboembolism - prevention & control
Thrombosis
Young Adult
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Summary:Objective Due to an increasing number of reported thromboembolic events (TEE) after the administration of one intravenous immunoglobulin (IVIG) and one subcutaneous immunoglobulin (SCIG), pharmacovigilance and laboratory data were collected to analyse the root cause and assess the reporting frequency of TEEs for various IG products. Methods Paul‐Ehrlich‐Institut retrospectively analysed 228 reports of TEEs associated with six different IG products and estimated annual TEE‐reporting rates based on worldwide sale figures over a period of 6 years (2006–2011). In addition, non‐activated partial thromboplastin time (NAPTT) testing was performed to capture pro‐coagulant potential of six IG products (four IVIG and two SCIG). Results For three IVIGs, the drug‐related TEE‐reporting rates remained stable from 2006 to 2011 (0–0·83 cases per 1000 kg IVIG distributed). In contrast, the TEE rate of one IVIG increased significantly from 0·33 cases in 2006 to nearly nine cases in 2010 (P 200 s and a NAPTT ratio >0·8, whereas TEE‐associated batches of IG products with an increased TEE rate had a NAPTT ratio
ISSN:0042-9007
1423-0410
DOI:10.1111/vox.12025