PHARMACOVIGILANCE BY ECG MONITORING: DETECTION OF CARDIAC ADVERSE DRUG REACTIONS AMONG DIFFERENT THERAPEUTIC CLASSES

Abstract

Background: Drug-induced cardiovascular adverse drug reactions, including QT/QTc prolongation, conduction abnormalities, and arrhythmias, remain one of the major global safety challenges. Despite its simplicity and diagnostic value, the electrocardiogram is underutilized in real-world pharmacovigilance, particularly in outpatient and resource-limited settings. This review assesses the contribution of ECG monitoring to the detection of cardiac ADRs across major therapeutic classes.

Methods: This systematic review was conducted within the PECO framework. Detailed searches across MEDLINE/PubMed, EMBASE, Web of Science, Scopus, and grey literature sources were conducted. Eligible studies were trials involving human subjects receiving medications, with cardiac outcomes documented by ECG. Data extractions included ECG parameters related to the study drugs, demographic data, and clinical outcomes.

Results: In studies representing more than 1.7 million patients, ECG-detected cardiac ADRs occurred in about 1.06% of the exposed, with higher frequencies among psychotropic (1.8%) and chemotherapeutic agents (1.6%). The most frequent abnormality was QT/QTc prolongation, followed by conduction delays and arrhythmias. Automated EHR-based systems (NLP+RDI) showed high performance: sensitivity 93.8%, specificity 91.8%, and a reduction in manual review workload of approximately 75%. Demographic and clinical risk factors consistently identified as associated with higher ADR risk included older age, male sex, polypharmacy, and pre-existing cardiovascular disease.

Conclusion: ECG-based pharmacovigilance represents a robust and scalable approach toward cardiac ADR detection across diverse drug classes. Routine ECG monitoring, integrated with automated EHR-driven detection, offers a more sensitive, timely, and efficient approach to identifying ADRs, particularly in real-world, polypharmacy settings.

                 

Peer Review History:

Received 26 September 2025;   Reviewed 10 November 2025; Accepted  22 December; Available online 15 January 2026

Academic Editor: Dr. Gehan Fawzy Abdel Raoof Kandeel, Pharmacognosy Department, National Research Centre, Dokki, 12622,  Giza, Egypt, gehankandeel9@yahoo.com 

Reviewers:

Dr. Tamer Elhabibi, Suez Canal University, Egypt, tamer_hassan@pharm.suez.edu.eg

Dr. Sameh Abdelmoneem Mohammed Ali, Faculty of Pharmacy, Beni-Suef University, Egypt, same7_pharma18@yahoo.com