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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1419196

Dexmedetomidine: A real-world safety analysis base on FDA adverse event reporting system database

Provisionally accepted
Yichun Shuai Yichun Shuai 1Zhe Chen Zhe Chen 2,3Qiaoqian Wan Qiaoqian Wan 1Jinzheng Wu Jinzheng Wu 1*Xin Wang Xin Wang 1*
  • 1 Department of Anesthesiology, Second Xiangya Hospital, Central South University, Changsha, China
  • 2 Second Xiangya Hospital, Central South University, Changsha, Hunan Province, China
  • 3 Department of Thoracic Surgery, Second Xiangya Hospital, Central South University, Changsha, China

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

    Objective: Using the FDA adverse event reporting system (FAERS) database to analyze the safety profile of Dexmedetomidine and provide guidance for clinical application. Methods: Data from the FAERS database from the first quarter of 2004 to the third quarter of 2023 were collected. Reporting odds ratio (ROR), the proportional reporting ratio (PRR), and the Bayesian confidence propagation neural network (BCPNN) were employed to detect and assess adverse events associated with Dexmedetomidine. Results: A total of 1910 reports of Dexmedetomidine as the primary suspect drug were obtained. After screening, 892 preferred terms were obtained, including 52 new preferred terms not mentioned in the drug insert. The common adverse events of Dexmedetomidine include bradycardia, cardiac arrest, hypotension, diabetes insipidus, arteriospasm coronary and agitation. Notably, cardiac disorders exhibited the highest number of reports and the highest signal intensity in the system organ class. Among the new preferred terms, those with high signal intensity include transcranial electrical motor evoked potential monitoring abnormal, acute motor axonal neuropathy, trigemino-cardiac reflex, glossoptosis, floppy iris syndrome, phaeochromocytoma crisis, postresuscitation encephalopathy and diabetes insipidus. Conclusion: This study mined and evaluated adverse events associated with Dexmedetomidine and also identified new adverse events. This could help alert clinicians to new adverse events not mentioned in the drug inserts, reducing the risk of drug.

    Keywords: Adverse event, Dexmedetomidine, FDA Adverse Event Reporting System, Real-world, Safety

    Received: 17 Apr 2024; Accepted: 12 Aug 2024.

    Copyright: © 2024 Shuai, Chen, Wan, Wu and Wang. 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:
    Jinzheng Wu, Department of Anesthesiology, Second Xiangya Hospital, Central South University, Changsha, China
    Xin Wang, Department of Anesthesiology, Second Xiangya Hospital, Central South University, Changsha, 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.