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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Neuropharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1465245

Adverse Event Profile of Lorazepam: A Real-World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database

Provisionally accepted
  • 1 The Affiliated Kangning Hospital of Wenzhou Medical University, Zhejiang Provincial Clinical Research Center for Mental Disorder, wenzhou, China
  • 2 Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China., wenzhou, China

The final, formatted version of the article will be published soon.

    Anxiety diagnoses have surged recently during and after the COVID-19 pandemic. Lorazepam is widely recognized for its efficacy in treatment of anxiety, as well as insomnia etc. However, the long-term safety profile of lorazepam in extensive patient populations has not been thoroughly established. This study aims to evaluate the potential lorazepam-associated adverse events (AEs) using data mining of the Food and Drug Administration Adverse Event Reporting System (FAERS) of the United States, seeking to provide a guidance for the future therapeutic practices. Our study revealed drug abuse, suicide attempt, sopor, delirium, and psychotic disorder were among the most prevalent AEs linked to lorazepam. In addition to common AEs, we also found that patients using lorazepam may have the risk of abnormal fat metabolism, cardiac impairment, and immunosuppression-related disorders. In general, our research has unveiled novel AE signals and expanded our understanding of the safety profile of lorazepam in clinical practices, providing guidance for its rational use.

    Keywords: Anxiety, Lorazepam, FAERS, adverse events, Data Mining

    Received: 16 Jul 2024; Accepted: 23 Oct 2024.

    Copyright: © 2024 Su, Huang, Chen and Li. 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: Zhengkang Su, The Affiliated Kangning Hospital of Wenzhou Medical University, Zhejiang Provincial Clinical Research Center for Mental Disorder, wenzhou, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.