Adverse drug events associated with metreleptin administration: a real-world pharmacovigilance study from 2014 to 2024 using the FAERS database.

Background: This study analyzed adverse drug event (ADE) signals associated with metreleptin using the FDA Adverse Event Reporting System (FAERS) to provide insights for safe clinical use.

Research Design And Methods: Data from 1 January 2014, to 31 March 2024, were extracted. Signal intensity for adverse events was assessed using reporting odds ratio (ROR), Medicines and Healthcare Products Regulatory Agency (MHRA), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods. Time-to-onset (TTO) correlations were evaluated using the Weibull shape parameter (WSP). Logistic regression identified potential hospitalization risk factors.

Results: 4,000 ADE reports were identified, with 1,025 significant events mainly involving females (66.73%) and reported by healthcare professionals (67.80%), primarily from the United States (84.10%). 101 preferred term (PT) signals were confirmed by all methods, with 57 PTs not listed on the drug label. Overall TTO was 547 days (IQR: 113-1325), with gastrointestinal disorders and investigations as hospitalization risk factors.

Conclusions: This study provides critical insights into the TTO of ADEs related to metreleptin, informing safe clinical application and emphasizing the importance of monitoring potential side effects.