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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1448144
This article is part of the Research Topic Advances in Drug-induced Diseases Volume II View all 29 articles

Adverse Event Profile of Albumin-bound Paclitaxel: A Real-World Pharmacovigilance Analysis

Provisionally accepted
Yuanqiong Duan Yuanqiong Duan 1Ying Wang Ying Wang 2Shentao Lu Shentao Lu 2Mei Zeng Mei Zeng 3Liu Lubin Liu Lubin 2Qian Dai Qian Dai 3Rutie Yin Rutie Yin 1*
  • 1 West China Second University Hospital, Sichuan University, Chengdu, China
  • 2 Chongqing Health Center for Women and Children, Chongqing, Chongqing, China
  • 3 Institute of Rheumatology and Immunology, Affiliated Hospital of North Sichuan Medical College, nanchong, China

The final, formatted version of the article will be published soon.

    Abraxane plays a crucial role in the treatment of various types of cancer, despite the considerable attention it has garnered for its adverse drug events (ADEs).Nevertheless, there is currently a significant lack of comprehensive real-world pharmacovigilance studies on the ADEs associated with Abraxane.We conducted a retrospective analysis of ADEs associated with Abraxane using data mining from the FAERS database, analyzing data from 2005 to 2023. In a realworld setting, we quantified and visualized the signals of these ADEs using four pharmacovigilance algorithms.The FAERS database identified a total of 10,230 adverse event reports associated with Abraxane. The study revealed that Abraxane-related adverse drug events involved 27 system organ classes (SOC), with the strongest signals associated with the lymphatic and hematological systems and hepatobiliary disorders. Additionally, we identified 70 significant Preferred Terms (PT) signals, which included some critical adverse events not highlighted in the product labeling, such as cystoid macular edema. Further analysis of the timing of adverse reactions showed a median onset time of 41 days. Most adverse events (AEs) occurred within the first month of using Abraxane (43.5%), although some were still possible one year after treatment (3.5%).Gender-specific analysis indicated that high-risk AEs differed between females (nausea, vomiting, and erythema) and males (febrile neutropenia, disseminated intravascular coagulation, and upper gastrointestinal bleeding).The examined results provide crucial recommendations for optimizing the administration of Abraxane, enhancing its effectiveness, and mitigating potential adverse effects. This knowledge will substantially facilitate the implementation of the substance in clinical settings.

    Keywords: Albumin-bound paclitaxel, Adverse drug events, FDA Adverse Event Reporting System, Signal mining, pharmacovigilance analysis, Real-world study

    Received: 12 Jun 2024; Accepted: 08 Oct 2024.

    Copyright: © 2024 Duan, Wang, Lu, Zeng, Lubin, Dai and Yin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Rutie Yin, West China Second University Hospital, Sichuan University, Chengdu, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.