Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports.
Purpose: The recent surge in serious adverse events (SAEs) and deaths associated with ferric carboxymaltose (FCM) underscores the importance of evaluating its safety profile. Methods: We conducted a retrospective case/non-case study from Q4 of 2003 to Q4 of 2024 data on FCM in the FDA Adverse Event...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 81; no. 7; pp. 1081 - 1097 |
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| Autores principales: | , , , , , , |
| Formato: | research systematic review tables/charts Journal Article |
| Publicado: |
Springer Nature
Jul2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=185843092&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 185843092 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Jul2025 vid: 81 iid: 7 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 185843092 185334894 185843092 185843092 10.1007/s00228-025-03849-z 185843092 ppf: 1081 ppct: 16 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports. aug: au: Galigutta, Reddikumar Reddy Thomas, Christy Rathod, Mahesh Hasik, P. N. Ray, R. S. Prakash, Jai Undela, Krishna affil: https://ror.org/04p9b6182 Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER) Guwahati, Kamrup, Assam, India sug: subj: Ferric Compounds Adverse Effects Signal Processing, Computer Assisted Death Data Analysis, Statistical Methods Human Systematic Review Retrospective Design Case Studies Clinical Data Repository Odds Ratio PubMed Patient Safety Anaphylaxis Risk Factors Lung Diseases Risk Factors Hypophosphatemia Risk Factors Arrhythmia Risk Factors Hypersensitivity Risk Factors Cardiovascular Risk Factors Risk Assessment ab: Purpose: The recent surge in serious adverse events (SAEs) and deaths associated with ferric carboxymaltose (FCM) underscores the importance of evaluating its safety profile. Methods: We 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. Results: In 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, IC025 = − 2.3). Nonetheless, positive safety signals emerged for SAEs such as anaphylactic shock (PRR = 3.9, LB ROR = 2.3, IC025 = 1.0), circulatory collapse (PRR = 14.6, LB ROR = 10.5, IC025 = 3.1), respiratory distress (PRR = 9.6, LB ROR = 7.1, IC025 = 2.6), hypophosphatemia (PRR = 520.7, LB ROR = 530.1, IC025 = 8.0), and arrhythmia (PRR = 3.3, LB ROR = 2.2, IC025 = 1.0). After meticulously refining our analysis to account for the influence of concomitant medications, we observed that the strength of all signals remained unchanged, except for respiratory distress, bradycardia, hypotension, abdominal pain, and urticaria. Analysis of VigiBase data revealed 42 reported fatal cases and potential signals for hypersensitivity (PRR = 4.5, LB ROR = 4.4, IC025 = 2.1), anaphylactic shock (PRR = 2.3, LB ROR = 1.9, IC025 = 0.9), circulatory collapse (PRR = 7.2, LB ROR = 6.0, IC025 = 2.5), respiratory distress (PRR = 6.9, LB ROR = 5.7, IC025 = 2.5), and hypophosphatemia (PRR = 245.1, LBROR = 234.8, IC025 = 7.5) with Ferinject. The systematic review of 11 case reports emphasized SAEs linked to FCM, thereby strengthening this association. Conclusion: This 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. pubtype: Academic Journal doctype: research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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