ArticleInternational journal of clinical pharmacy2023
Data mining and analysis for emicizumab adverse event signals based on the Food and Drug Administration Adverse Event Reporting System database.
Article in International journal of clinical pharmacy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The trial behind it
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Who cites it
8 citing papers in PubMed, 14 citations in OpenAlex.
- Possible clinical drug interactions between ticagrelor and concomitant medications: for adverse drug event monitoring in real-world.Cardiovascular drugs and therapy · 2026Article
- Denosumab safety in men with osteoporosis: a disproportionality analysis of the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Identifying High-Risk Medications for Drug-Induced Dystonia: A 20-Year Retrospective Real-World Pharmacovigilance Study Based on FAERS.Health science reports · 2026Article
- More real-world evidence on the impact of emicizumab.Research and practice in thrombosis and haemostasis · 2025Article
- Real-world study of adverse events associated with triptan use in migraine treatment based on the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS) database.The journal of headache and pain · 2024Article
- GC-MS based metabolomic profiling of Aporosa cardiosperma (Gaertn.) Merr. leaf extracts and evaluating its therapeutic potential.Scientific reports · 2024Article
- Progress in the treatment of advanced hepatocellular carcinoma with immune combination therapy.World journal of gastrointestinal oncology · 2024Review
- A disproportionality analysis of FDA adverse event reporting system (FAERS) events for ticagrelor.Frontiers in pharmacology · 2024Article
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundEmicizumab is the latest treatment for patients with hemophilia A. Its safety in real-world data is limited, and regulatory agencies and clinical researchers have raised concerns about the risk of adverse events.
aimThis study aimed to detect potential adverse event signals of emicizumab using the FDA Adverse Event Reporting System (FAERS) database.
methodData in FAERS from the fourth quarter of 2017 to the second quarter of 2021 were searched. Cases of adverse events were extracted using the Preferred Term in the Medical Dictionary for Regulatory Activities (version 24.0). Disproportionality analysis was performed using the reporting odds ratio (ROR) and information component (IC) methods based on statistical shrinkage transformation.
resultsA total of 5,598,717 patients were included, of which 1,244 took emicizumab. A total of 703 emicizumab-related adverse event signals were mined, and 101 positive signals were detected. Haemarthrosis (ROR/ROR
conclusionThis study found that mild arthralgia and injection site reaction were associated with emicizumab. Attention should also be paid to other serious adverse events related to emicizumab, such as acute myocardial infarction and sepsis, to ensure patient safety.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.