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Thromboembolic events associated with immunoglobulin treatment
1Department of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany. Markus.Funk@pei.de
Vox Sanguinis
|February 13, 2013
Summary
Thromboembolic event (TEE) rates increased for one intravenous immunoglobulin (IVIG) product, linked to its pro-coagulant potential. Manufacturing changes normalized lab results and reduced TEEs, improving immunoglobulin product safety.
Area of Science:
- Immunology
- Pharmacovigilance
- Hematology
Background:
- Increasing reports of thromboembolic events (TEEs) associated with immunoglobulin (IG) products, including intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG), prompted further investigation.
- Understanding the root cause and reporting frequency of TEEs across different IG products is crucial for patient safety.
Purpose of the Study:
- To analyze the root cause of increased thromboembolic events (TEEs) linked to specific immunoglobulin (IG) products.
- To assess the reporting frequency of TEEs for various IVIG and SCIG products using pharmacovigilance and laboratory data.
Main Methods:
- Retrospective analysis of 228 TEE reports associated with six IG products from 2006-2011.
- Estimation of annual TEE-reporting rates based on global sales data.
- Non-activated partial thromboplastin time (NAPTT) testing to evaluate the pro-coagulant potential of IG products.
Main Results:
- TEE-reporting rates remained stable for three IVIG products but significantly increased for one IVIG product between 2006 and 2010.
- IG products with low TEE rates showed NAPTT time >200 s and NAPTT ratio >0.8.
- TEE-associated IG batches exhibited a NAPTT ratio <0.8, indicating increased pro-coagulant potential.
Conclusions:
- Specific manufacturing processes in certain IG products can lead to increased thromboembolic event (TEE) rates.
- Non-activated partial thromboplastin time (NAPTT) testing can identify IG products with higher pro-coagulant potential.
- Modifications in manufacturing processes normalized NAPTT results and successfully reduced TEE rates, enhancing product safety.
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