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. 2024 Oct;42(5):500-509.
doi: 10.1007/s10637-024-01457-9. Epub 2024 Aug 12.

Post-marketing safety concerns with relugolix: a disproportionality analysis of the FDA adverse event reporting system

Chunyong Xia #  1 , Zhijing Liu #  2 , Jie Liu  1 , Li Lin  3 , Maohua Chen  4
Affiliations

Post-marketing safety concerns with relugolix: a disproportionality analysis of the FDA adverse event reporting system

Chunyong Xia et al. Invest New Drugs. 2024 Oct.

Abstract

Background: Relugolix has been used to treat advanced prostate cancer. This study assessed adverse events (AEs) associated with relugolix from the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: Disproportionality analysis, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed to quantify the signals of relugolix-associated AEs.

Results: A total of 5,059,213 reports of AEs were collected from the FAERS database, of which 5,662 reports were identified with relugolix as the "primary suspect (PS)". A total of 70 significant disproportionality PTs conforming to the four algorithms were simultaneously retained. Unexpected new AEs, such as erectile dysfunction, gynaecomastia, testicular atrophy, male genital atrophy, libido decreased might also occur.

Conclusion: This study found potential new AEs signals and might provide important support for clinical monitoring and risk identification of relugolix.

Keywords: Adverse events; Efficacy; FAERS; Prostate cancer; Relugolix; Safety.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests. Ethical approval: The FAERS database contains anonymized patient information. The Hospital Ethics Committee has confirmed that no ethical approval was required.

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