ArticleInternational journal of surgery (London, England)2025
Safety evaluation of inotuzumab ozogamicin: a pharmacovigilance study based on the FAERS database.
Article in International journal of surgery (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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Who cites it
3 citing papers in PubMed.
- Chronic portal hypertension following inotuzumab ozogamicin in a low-risk patient: a case of overriding baseline risk and long-term management.Annals of hematology · 2026Article
- A real-world study of adverse event profiles associated with the four key components of antibody-drug conjugates based on the FAERS database.Frontiers in pharmacology · 2026Article
- Risk Signals of Antibody-Drug Conjugates in Bladder Cancer: A Real-World FAERS Study.Clinical epidemiology · 2025Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveGiven inotuzumab ozogamicin (InO) relatively recent market introduction and ongoing new drug surveillance period, further research is needed on its adverse drug events (ADEs) in the real world.
methodsRetrieve and analyze ADE reports associated with InO from the FAERS database, covering the period from 2004Q1 to 2024Q3, and employ the reporting odds ratio (ROR) methodology to conduct signal detection for InO-related ADEs.
resultsThis study analyzed 1007 (2725 ADEs) patients, focusing on critical issues like veno-occlusive liver disease (VOD) ( n = 97, ROR = 486.02), infections ( n = 20, ROR = 3.27), and febrile neutropenia ( n = 57, ROR = 20.43). Additionally, it also revealed some new ADEs, including sepsis ( n = 35, ROR = 7.14), cytokine release syndrome ( n = 22, ROR = 36.78), graft-versus-host disease ( n = 20, ROR = 62.21), enterocolitis infectious ( n = 3, ROR = 69.07), pneumonia fungal ( n = 6, ROR = 30.76), and multiple organ dysfunction syndrome ( n = 21, ROR = 10.65), among others. Consequently, it is imperative to exercise increased vigilance regarding these potential ADEs in the clinical administration of InO.
conclusionThis study underscores the potential ADEs and associated risks with the clinical application of InO, with particular emphasis on the risks of VOD, infections, and febrile neutropenia. The implementation of a vigilant monitoring strategy is crucial for the early detection and timely management of these potential complications.
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