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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Cardiovascular and Smooth Muscle Pharmacology
Volume 15 - 2024 |
doi: 10.3389/fphar.2024.1523136
This article is part of the Research Topic Advanced Therapeutic Strategies and Safety Profiles in Heart Failure with Reduced Ejection Fraction View all 3 articles
Drug-induced heart failure: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database
Provisionally accepted- 1 Shengli Clinical College of Fujian Medical University, Department of Pharmacy, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou 350001, China., Fuzhou, Fujian Province, China
- 2 College of Pharmacy, Fujian Medical University, Fuzhou 350004, China., Fuzhou, China
- 3 Department of pharmacy, Xiamen Medical College, Xiamen 361023, China., Xiamen, China
Objective: Although there are certain drug categories associated with heart failure (HF), most of the associated risks are unclear. We investigated the top drugs associated with HF and acute HF (AHF) reported in the FDA Adverse Event Reporting System (FAERS).Methods: We reviewed publicly available FAERS databases from 2004 to 2023. Using the search terms "cardiac failure" or "cardiac failure acute" and classifying cases by drug name, we processed and analyzed drug reports related to HF or AHF.Results: From 2004 to 2023, 17,379,609 adverse drug events were reported by FAERS, of which 240,050 (1.38%) were reported as HF. Among those with HF, the male-to-female ratio was 0.94 and 52.37% were >65 years old; 46.2% were from the United States. There were 5971 patients with AHF. We identified 38 drugs and 13 drug classes with a potential high risk of causing HF, and 41 drugs and 19 drug classes were associated with AHF. The median onset times of HF and AHF were 83 days (IQR: 11-416) and 49 days (IQR: 8-259), respectively. The Weibull shape parameter (WSP) test showed early failure-type profile characteristics.Conclusion: This study highlights key drugs associated with drug-induced HF and AHF, emphasizing the importance of early risk assessment and close monitoring, particularly during the initial stages of treatment. These findings contribute to a better understanding of drug-induced HF and provide a basis for future research on its underlying mechanisms.
Keywords: Heart Failure, adverse events, Pharmacovigilance, FAERS, Data Mining
Received: 05 Nov 2024; Accepted: 24 Dec 2024.
Copyright: © 2024 Huang, Chen, Chen, Lin, Chen, Gao and Chen. 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:
Min Chen, Shengli Clinical College of Fujian Medical University, Department of Pharmacy, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou 350001, China., Fuzhou, Fujian Province, China
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