Evidence map›Paper›PMID 41560737›Full record

ArticleFrontiers in pharmacology2025

Pharmacovigilance study on neurological adverse reactions of proteasome inhibitors in the FDA adverse event reporting system.

Shuyue Li, Tao Ling, Yan Liu, Jun Li

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Shuyue Li *Department of Pharmacy, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China.
Tao Ling *Department of Pharmacy, Suqian First Hospital, Suqian, China.
Yan LiuDepartment of Hematopathology, Shanxi Provincial Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China.
Jun LiDepartment of Pharmacy, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Bortezomib, carfilzomib and ixazomib are the proteasome inhibitors (PIs) used to treat multiple myeloma (MM). We conducted a comprehensive pharmacovigilance analysis of their neurotoxicity using the Food and Drug Administration Adverse Event Reporting System (FAERS), including not only peripheral neurotoxicity but also central neurotoxicity, to provide reference for safe and rational clinical use. Methods: We obtained PIs' adverse reaction reports during Q1 2004 to Q2 2025 from the FAERS database. Adverse drug event (ADE) signals of bortezomib, carfilzomib and ixazomib were analyzed by statistical methods including Reporting Odds Ratio (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma-Poisson Shrinker (MGPS). ADEs sorted by frequency of occurrence and signal strength. Subgroup analyses based on gender was performed to explore differences. Time-to-onset profiles were analyzed using the Weibull Shape Parameter (WSP) test. Results: A total of 33,322, 14,063, and 16,562 ADEs of bortezomib, carfilzomib and ixazomib were analyzed, respectively from the FAERS database. The most common neurological adverse reaction signals for bortezomib, carfilzomib, and ixazomib are peripheral neuropathy (PN), with bortezomib having the highest number of reports (n = 2,681). Analysis shows that compared to the other two drugs, bortezomib exhibits higher signal intensity in neurological adverse events. The most prominent signal of bortezomib is autonomic neuropathy [n = 96; ROR 70.16 (95% CI 56.79-86.67)]. The strongest signal of carfilzomib is in hypertensive cephalopathy [n = 7; ROR 18.09 (95% CI 8.58-38.12)], while ixazomib has the highest signal in burning feet syndrome [n = 3; ROR 16.61 (95% CI 5.32-51.91)]. The median to onset time for neurological adverse events related to bortezomib, carfilzomib, and ixazomib were 33days (IQR 13-91), 35 days (IQR 9-145), and 80 days (IQR 19-251), respectively. Conclusion: In real-world pharmacovigilance studies, the peripheral neurotoxicity of carfilzomib and ixazomib was lower than that of bortezomib. In addition to PN, it is necessary to pay more attention to the special central neurological adverse events of PIs, such as posterior reversible encephalopathy syndrome (PRES) related to bortezomib and carfilzomib, and hypertensive encephalopathy related to carfilzomib, for early symptom identification and diagnosis. For ixazomib, attention should also be paid to neuromuscular symptoms and prevention of neuralgia caused by herpes zoster virus.

Indexed as

bortezomibcarfilzomibFAERSixazomibneurological adverse reaction

Identifiers

PMID41560737
PMCPMC12812994

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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.