SynthesisEuropean journal of clinical pharmacology2025
Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports.
Synthesis in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Real-world and computational identification of herbal candidates associated with adverse event patterns in glucagon-like peptide-1 therapy for obesity.Scientific reports · 2026Article
- Drug-induced neutropenia: A comprehensive pharmacovigilance study of the FAERS database.Medicine · 2026Article
- Real-world safety profile of anifrolumab: An observational disproportionality analysis of the FAERS database.Medicine · 2026Observational
- The Significance of Hypophosphatemia in Deciding on an Optimal Clinical Choice of Parenteral Iron Therapy in Patients with Chronic Inflammatory Bowel Disease in Slovenia: An Umbrella Review and Economic Evaluation.Healthcare (Basel, Switzerland) · 2026Article
- Ranking the Diabetes-related Safety Profile of Different Statin Drugs.Current pharmaceutical design · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe recent surge in serious adverse events (SAEs) and deaths associated with ferric carboxymaltose (FCM) underscores the importance of evaluating its safety profile.
methodsWe conducted a retrospective case/non-case study from Q4 of 2003 to Q4 of 2024 data on FCM in the FDA Adverse Event Reporting System (FAERS) and VigiBase databases. Signal detection was performed using proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The influence of concomitant medication on the identified signal was assessed and refined using Open Vigil 2.1. Additionally, to identify case reports on FCM-induced adverse events, a comprehensive search was performed in PubMed, Google Scholar, and Scopus databases from inception to April 12, 2025.
resultsIn the FAERS database, 46 deaths were reported in connection with FCM, though no significant death signal was observed (PRR = 0.3, LB (lower bound) ROR = 0.2, IC
conclusionThis study reveals that FCM carries SAEs. Providers must weigh the benefits and risks on a case-by-case basis, considering patient-specific factors. Continuous monitoring and further research are crucial for the safe use of FCM in iron deficiency anemia.
Indexed as
Identifiers
40402208What Socratic holds
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 Socratic graph.