ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Experimental Pharmacology and Drug Discovery
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1563238
This article is part of the Research TopicInsights in Experimental Pharmacology and Drug Discovery: 2024View all 10 articles
Adverse drug events associated with Insulin glargine: a real-world pharmacovigilance study based on the FAERS database
Provisionally accepted
- 1Department of Pharmacy, The First Hospital of Changsha, Changsha, Hunan, China, Changsha, China
- 2Department of Pharmacy, The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China, Changsha, China
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Background: Insulin glargine is a long-acting drug and the first synthetic insulin to mimic human metabolism. The safety of insulin glargine in the real world remains to be further investigated. This study aims to analyze insulin glargine-related adverse events (ADEs) to guide its safe clinical use.: This study collected ADE reports from the FDA Adverse Event Reporting System (FAERS) between the first quarter of 2004 and the third quarter of 2024, where insulin glargine was identified as the primary suspect drug. Four disproportionate analytical methods were employed to analyze positive signals for drug-related ADEs, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). The study also describes the time to onset of ADEs and uses the Weibull distribution to analyze the temporal trend of ADEs occurrence over time. Results: This study included 97,350 ADE reports, containing 228,258 ADEs, and identified 130 ADEs with positive signal. The study confirmed several known ADEs, such as hypoglycemia, injection site pain and acquired lipodystrophy. Additionally, several unexpected ADEs were identified, including pancreatic neoplasm, medullary thyroid cancer, and bone marrow tumor cell infiltration. 28.13% of ADEs occurred within the first month. The Weibull distribution indicated that the occurrence of ADEs decreased over time.This study explored the real-world safety of insulin glargine and revealed several unexpected ADEs. These findings provide new insights into the safety profile of insulin glargine for clinicians.
Keywords: Insulin glargine, adverse drug event, FAERS, Pharmacovigilance, Diabetes Mellitus
Received: 19 Jan 2025; Accepted: 18 Apr 2025.
Copyright: © 2025 Tongtong, He, Xiong and Juanjuan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Huang Juanjuan, Department of Pharmacy, The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China, Changsha, China
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