Evidence map›Paper›PMID 39558918›Full record

ArticleInternational journal of nanomedicine2024

Unveiling the Hidden Risks: An Update Decade-Long Analysis of Abraxane-Related Adverse Events from the FAERS Database.

Yue-Chen Zhao, Xin Li, Chao-Qun Wang, Yan Jiao, Yan-Nan Shen, Tie-Jun Wang, Chao-He Zhang

Abstract read
In one paragraph

Article in International journal of nanomedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Co-delivery of SN38 and rapamycin albumin bound nanoparticles against breast Cancer.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2025
    Article
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  7. Article
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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

7 authors.

Yue-Chen ZhaoDepartment of Radiation Oncology, The Second Hospital of Jilin University, Changchun, Jilin, People's Republic of China.ORCID 0000-0002-7098-5322
Xin LiDepartment of Radiology, The Second Hospital of Jilin University, Changchun, Jilin, People's Republic of China.
Chao-Qun WangDepartment of Gynaecology, Aviation General Hospital, Beijing, People's Republic of China.
Yan JiaoDepartment of Hepatobiliary and Pancreatic Surgery, General Surgery Center, First Hospital of Jilin University, Changchun, People's Republic of China.ORCID 0000-0001-6914-7949
Yan-Nan ShenNHC Key Laboratory of Radiobiology, School of Public Health, Jilin University, Changchun, Jilin, People's Republic of China.
Tie-Jun Wang *Department of Radiation Oncology, The Second Hospital of Jilin University, Changchun, Jilin, People's Republic of China.ORCID 0000-0002-2362-8007
Chao-He Zhang *Department of Hematology and Oncology, The Second Hospital of Jilin University, Changchun, Jilin, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Abraxane (nanoparticle albumin-bound paclitaxel) is a chemotherapeutic employed commonly for the management of various cancers including breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma. Although it has clinically beneficial properties, Abraxane is accompanied by multiple adverse events (AEs) that require close observation. This study aims to evaluate the AE profile of Abraxane using recently available data from January 2004 through December 2023 in the FDA Adverse Event Reporting System (FAERS). Patients and Methods: The data for Abraxane-related AEs were obtained from the FAERS database. The dataset consisted of patient demographic characteristics as well as information on the types and outcomes of AEs reported. Reporting odds ratios (ROR) as well as proportional reporting ratio (PRR), considering the used definition of anti-cancer agent and AEs, were calculated to investigate any association with Abraxane. Results: A total of 10,310 reports associated with Abraxane AEs were identified. Blood and lymphatic system disorders were the most frequent (ROR 6.44), followed by hepatobiliary (ROR 3.16), infections (ROR 1.45), and gastrointestinal disorders (ROR 1.42). Serious outcomes included hospitalization in 36.35% and death in 29.76% of cases. The top adverse reactions matched known profiles, including peripheral sensory neuropathy (ROR: 49.48). The analysis also found new adverse reactions, such as scleroderma-like reactions (ROR: 95.4) and vascular pseudoaneurysm ruptures (ROR: 87.71). Conclusion: Our results re-emphasize the importance of a robust Post Marketing Surveillance system and suggest this FAERS database based analysis provides an updated, independent information on Abraxane related AEs to enrich its safety profile. A process of continuous vigilance and additional investigations on specific areas that may have some undesired events are imperative to increase our knowledge on how Abraxane should be handled in terms of its safety.

Indexed as

Adverse Drug Reaction Reporting SystemsAlbumin-Bound PaclitaxelDatabases, FactualAdultAgedAntineoplastic AgentsDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMiddle AgedNeoplasmsUnited StatesUnited States Food and Drug AdministrationAlbumin-Bound PaclitaxelAntineoplastic AgentsAbraxaneadverse eventsFAERS databasepharmacovigilancesignal detection

Identifiers

PMID39558918
PMCPMC11572439

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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.