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Risk Factors Associated With Thrombocytopenia Induced by Intravenous Immunoglobulin Formulations: An Analysis Using
Yoshihiro Nishita1,2, Natsuko Ishida3, Hirofumi Nagai2
1Clinical Pharmacy and Healthcare Science, Kanazawa University, Kanazawa, Japan; yoshi-n@kanazawa-med.ac.jp.
In Vivo (Athens, Greece)
|June 27, 2025
Summary
Intravenous immunoglobulin (IVIg) can cause thrombocytopenia. Elderly patients and those with immune-mediated skin or muscular diseases face a higher risk of this adverse event.
Area of Science:
- Pharmacovigilance
- Immunology
- Hematology
Background:
- Thrombocytopenia is a known adverse event associated with intravenous immunoglobulin (IVIg) formulations.
- Previous reports were limited to individual case studies, lacking epidemiological data.
- This study addresses the need for epidemiological investigation into IVIg-induced thrombocytopenia.
Purpose of the Study:
- To investigate the risk of thrombocytopenia associated with IVIg.
- To identify factors contributing to IVIg-induced thrombocytopenia.
- To analyze IVIg adverse event data from a large Japanese database.
Main Methods:
- Utilized Japanese Adverse Drug Event Report database from April 2004 to August 2024.
- Employed reporting odds ratio (ROR) to assess the association between IVIg and thrombocytopenia.
- Applied multiple logistic regression to identify associated factors, including age, sex, formulation, and disease group.
Main Results:
- A significant association was found between IVIg use and thrombocytopenia.
- Pemphigoid, Kawasaki disease, and polymyositis/dermatomyositis were frequently reported diseases.
- Increased risk of thrombocytopenia was observed in patients aged 60 and older, and those with immune-mediated skin and muscular diseases.
Conclusions:
- Intravenous immunoglobulin (IVIg) is associated with an increased risk of thrombocytopenia.
- Clinical assessment for thrombocytopenia is recommended for elderly patients.
- Patients with immune-mediated skin and muscular diseases require careful monitoring during IVIg therapy.
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