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Updated: Jun 5, 2025

A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
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A 13-years pharmacovigilance analysis of novel hormonal agents in prostate cancer using the FDA adverse event

Haiwei Xiao1, Tao Qin2,3, Yanping Wen4

  • 1Department of Traditional Chinese Medicine, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, Guangdong Province, China.

Expert Opinion on Drug Safety
|December 13, 2024
PubMed
Abstract

Insights

Novel hormonal agents (NHAs) for prostate cancer show specific adverse events. Vascular disorders are a risk for all NHAs, especially with chemotherapy or PARP inhibitors. Individual drugs have unique toxicity profiles.

Area of Science:

  • Oncology
  • Pharmacovigilance
  • Drug Safety

Background:

  • Novel hormonal agents (NHAs) are crucial in prostate cancer therapy.
  • Real-world data on NHA toxicity remains incompletely understood.
  • This study investigates adverse events (AEs) associated with NHAs.

Purpose of the Study:

  • To analyze the safety profiles of NHAs.
  • To identify and compare specific adverse event signals across different NHAs.
  • To provide real-world safety insights for clinical decision-making.

Main Methods:

  • Utilized the US FDA Adverse Event Reporting System (FAERS) database.
  • Employed disproportionality analysis to detect safety signals.
  • Compared AE profiles among abiraterone, apalutamide, enzalutamide, and darolutamide.

Main Results:

  • All NHAs showed safety signals in vascular disorders, with increased risk when combined with docetaxel or PARP inhibitors (blood/lymphatic system).
  • Apalutamide, enzalutamide, and darolutamide had nervous system disorder signals; abiraterone did not.
  • Specific AEs: Apalutamide (skin/subcutaneous), Enzalutamide (gastrointestinal), Abiraterone (cardiac/hepatobiliary).

Conclusions:

  • This study provides a comprehensive overview of NHA safety signals.
  • Findings serve as a valuable reference for selecting NHAs.
  • Highlights the need for further prospective research on NHA-associated toxicities.
Keywords:
FAERSNovel hormone agentsabirateroneadverse eventsapalutamidedarolutamideenzalutamideprostate cancer

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