Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database.
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| Titel: | Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database. |
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| Autoren: | Luo J; School of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People's Republic of China., Chen S; School of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People's Republic of China., Zhang M; School of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People's Republic of China., Gao Y; School of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People's Republic of China., Zeng Y; Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, People's Republic of China. |
| Quelle: | Hematology (Amsterdam, Netherlands) [Hematology] 2025 Dec; Vol. 30 (1), pp. 2534758. Date of Electronic Publication: 2025 Jul 21. |
| Publikationsart: | Journal Article |
| Sprache: | English |
| Info zur Zeitschrift: | Publisher: Taylor & Francis Country of Publication: England NLM ID: 9708388 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1607-8454 (Electronic) Linking ISSN: 10245332 NLM ISO Abbreviation: Hematology Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2016- : Abingdon : Taylor & Francis Original Publication: [Amsterdam] : Newark, NJ : Harwood Academic Publishers ; International Publishers Distributor, |
| MeSH-Schlagworte: | Multiple Myeloma*/drug therapy , Pharmacovigilance* , Proteasome Inhibitors*/adverse effects , Proteasome Inhibitors*/therapeutic use , Adverse Drug Reaction Reporting Systems* , Drug-Related Side Effects and Adverse Reactions*/epidemiology , Drug-Related Side Effects and Adverse Reactions*/etiology, Humans ; Male ; Female ; Databases, Factual ; Middle Aged ; Aged ; United States ; Bortezomib/adverse effects |
| Abstract: | Background: Proteasome inhibitors (PIs) such as Bortezomib, Carfilzomib, and Ixazomib have significantly improved outcomes in multiple myeloma (MM), but their real-world safety profiles require further exploration. Objective: To assess adverse drug events (ADEs) associated with Bortezomib, Carfilzomib, and Ixazomib in MM patients using the FDA Adverse Event Reporting System (FAERS), and to identify new ADE signals not listed in product labels. Methods: A total of 47,310 ADE reports (Bortezomib: 23,843; Carfilzomib: 9,835; Ixazomib: 13,632) were analyzed from FAERS (2004 - Q4 2024). Signal detection was conducted using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Onset time was evaluated using Weibull survival analysis. Results: All three PIs were associated with significant ADE signals across multiple system organ classes, notably in the hematologic, nervous, cardiovascular, hepatobiliary, and gastrointestinal systems. Newly identified ADEs included muscular weakness (Bortezomib), pancytopenia (Carfilzomib), and cognitive disorder (Ixazomib). Onset time analysis showed that most ADEs occurred within the first 30 days of treatment. Conclusion: This study highlights both known and newly detected ADEs linked to PIs, emphasizing the importance of early-phase monitoring and ongoing pharmacovigilance. The findings provide crucial real-world evidence for clinical risk management and future label updates. |
| Contributed Indexing: | Keywords: FAERS; Multiple myeloma; Pharmacovigilance; adverse drug events; onset time; proteasome inhibitors |
| Substance Nomenclature: | 0 (Proteasome Inhibitors) 69G8BD63PP (Bortezomib) |
| Entry Date(s): | Date Created: 20250722 Date Completed: 20250722 Latest Revision: 20250722 |
| Update Code: | 20250722 |
| DOI: | 10.1080/16078454.2025.2534758 |
| PMID: | 40692299 |
| Datenbank: | MEDLINE |
Nájsť tento článok vo Web of Science | Abstract: | Background: Proteasome inhibitors (PIs) such as Bortezomib, Carfilzomib, and Ixazomib have significantly improved outcomes in multiple myeloma (MM), but their real-world safety profiles require further exploration.<br />Objective: To assess adverse drug events (ADEs) associated with Bortezomib, Carfilzomib, and Ixazomib in MM patients using the FDA Adverse Event Reporting System (FAERS), and to identify new ADE signals not listed in product labels.<br />Methods: A total of 47,310 ADE reports (Bortezomib: 23,843; Carfilzomib: 9,835; Ixazomib: 13,632) were analyzed from FAERS (2004 - Q4 2024). Signal detection was conducted using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Onset time was evaluated using Weibull survival analysis.<br />Results: All three PIs were associated with significant ADE signals across multiple system organ classes, notably in the hematologic, nervous, cardiovascular, hepatobiliary, and gastrointestinal systems. Newly identified ADEs included muscular weakness (Bortezomib), pancytopenia (Carfilzomib), and cognitive disorder (Ixazomib). Onset time analysis showed that most ADEs occurred within the first 30 days of treatment.<br />Conclusion: This study highlights both known and newly detected ADEs linked to PIs, emphasizing the importance of early-phase monitoring and ongoing pharmacovigilance. The findings provide crucial real-world evidence for clinical risk management and future label updates. |
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| ISSN: | 1607-8454 |
| DOI: | 10.1080/16078454.2025.2534758 |