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Updated: Jun 4, 2025

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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Adverse drug events associated with metreleptin administration: a real-world pharmacovigilance study from 2014 to

Jinhao He1, Xuehu Luo1, Jie Liu1

  • 1Department of Pharmacy, The Third Affiliated Hospital of Chengdu Medical College, Pidu District People's Hospital of Chengdu, Chengdu, Sichuan, China.

Expert Opinion on Drug Safety
|December 18, 2024
PubMed
Abstract

Insights

This study identified over 100 adverse drug event signals for metreleptin, with 57 new signals not on the drug label. Gastrointestinal issues were linked to hospitalization, informing safer clinical use.

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Clinical Pharmacology

Background:

  • Adverse drug events (ADEs) are a significant concern in patient care.
  • Metreleptin is used for specific metabolic disorders, necessitating safety monitoring.
  • Understanding ADE signals is crucial for optimizing therapeutic strategies.

Purpose of the Study:

  • To analyze adverse drug event (ADE) signals associated with metreleptin.
  • To provide insights for the safe clinical use of metreleptin.
  • To identify potential risk factors for hospitalization related to metreleptin therapy.

Main Methods:

  • Utilized the FDA Adverse Event Reporting System (FAERS) database from January 2014 to March 2024.
  • Assessed signal intensity using multiple statistical methods: ROR, MHRA, BCPNN, and MGPS.
  • Analyzed time-to-onset (TTO) with Weibull shape parameter (WSP) and identified hospitalization risk factors via logistic regression.

Main Results:

  • Identified 4,000 ADE reports, with 1,025 significant events, predominantly in females and reported by healthcare professionals.
  • Confirmed 101 preferred term (PT) signals across all methods, including 57 PTs not previously listed on the drug label.
  • Observed a median TTO of 547 days; gastrointestinal disorders and investigations were identified as hospitalization risk factors.

Conclusions:

  • The study highlights critical insights into the time-to-onset of metreleptin-associated ADEs.
  • Findings emphasize the importance of ongoing monitoring for potential side effects.
  • Results inform safer clinical application of metreleptin, improving patient outcomes.
Keywords:
FAERS databaseadverse drug eventslipodystmphic syndmmesmetreleptinreal-world study

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