Novel insights into post-marketing AEs associated with leuprorelin: A comprehensive analysis utilizing the FAERS database

Abstract

Purpose: This research focused on meticulously tracking and identifying adverse reactions associated with leuprorelin, a drug prescribed for conditions such as prostate cancer, endometriosis, uterine fibroids, and early-onset puberty. The main objective was to enhance patient safety and offer informed guidance on the appropriate use of this treatment.

Methods: From the first quarter of 2004 to the fourth quarter of 2023, a comprehensive analysis was conducted on a significant number of adverse event reports (AERs) from the FDA Adverse Event Reporting System (FAERS) database. Data mining with dismutation analysis was conducted to quantify signals associated with adverse events (AEs) related to leuprorelin, utilizing powerful algorithms such as ROR, PRR, BCPNN, and EBGM.

Results: A total of 102 positive reaction terms (PT) spanning 24 System Organ Classes (SOCs) were identified from an analysis of 60,709 reports associated with leuprorelin use. Notably, several previously unrecognized adverse reactions were uncovered, including Artificial Menopause, Ovarian Adhesion, Follicular Cystitis, Intercepted product preparation error, among others. These findings underscore the importance of exercising additional vigilance regarding the potential adverse effects of leuprorelin, such as Abscess Sterile, Injection site granuloma, Intercepted medication error, and Bulbospinal muscular atrophy congenital.

Conclusions: This research has successfully uncovered new and unforeseen signals associated with adverse drug reactions (ADRs) following leuprorelin administration. The study provides valuable insights into the intricate connection between ADRs and leuprorelin usage. The results underscore the crucial significance of continuous surveillance and meticulous monitoring to promptly identify and manage AEs, ultimately enhancing patient safety and well-being while undergoing leuprorelin therapy.

Keywords: BCPNN; EBGM; FAERS; Leuprorelin; PRR; ROR.

Fig. 1

The flow diagram of selecting leuprorelin -related AEs from FAERS database. (DEMO, demographic and administrative information; DRUG, drug Information; REAC, preferred terminology for adverse drug reactions; PS, primary suspect drug).