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Testing the Efficacy of Pharmacological Agents in a Pericardial Target Delivery Model in the Swine
Published on: July 7, 2016
Drug-Induced Noninfectious Myocarditis/Pericarditis: A Real-World Pharmacovigilance Study Using the FAERS Database.
Shijie Zhao1, Weiyi Chen2,3, Chao Tao3,4
1Department of Clinical Research, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, 610041, China.
Cardiovascular Toxicology
|May 21, 2026
Summary
This pharmacovigilance study identified drugs linked to noninfectious myocarditis/pericarditis using FDA adverse event data. Clozapine, nivolumab, and pembrolizumab were among the top suspected drugs, highlighting risks with immune checkpoint inhibitors.
Area of Science:
- Pharmacovigilance
- Cardiology
- Drug Safety
Background:
- Drug-induced noninfectious myocarditis/pericarditis is a serious adverse event.
- Identifying causative agents is crucial for patient safety and clinical management.
Purpose of the Study:
- To identify primary suspected drugs associated with drug-induced noninfectious myocarditis/pericarditis.
- To analyze adverse event reports from the FDA Adverse Event Reporting System (FAERS) database (2004-2023).
Main Methods:
- Utilized a standardized MedDRA query (SMQ) for "Noninfectious Myocarditis/Pericarditis".
- Employed disproportionality analyses: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN).
- Analyzed data at both SMQ and Preferred Term levels to detect drug signals.
Main Results:
- Identified 21,422 relevant adverse event reports and 953 primary suspect drugs.
- Detected potential drug signals for 193 (ROR), 163 (PRR), and 176 (BCPNN) drugs.
- Clozapine, nivolumab, and pembrolizumab were top suspected drugs; immune checkpoint inhibitors were a prominent category.
Conclusions:
- Findings provide a comprehensive overview of medications linked to drug-induced noninfectious myocarditis/pericarditis.
- Highlights the importance of monitoring for cardiac adverse events, especially with immune checkpoint inhibitors.
- Offers valuable reference information for clinicians to improve understanding and prevention strategies.
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