AN ASSESSMENT OF DRUG-INDUCED ORAL ULCERS IN CARDIAC AND CANCER PATIENTS: A PHARMACOVIGILANCE STUDY IN GENERAL DENTAL PRACTICE”
Main Article Content
Keywords
Malignancy, Oral ulcers, Chemotherapy and drug induced oral ulcers
Abstract
Introduction: Drug-induced oral ulcers are a clinically significant yet underreported adverse drug reaction (ADR), especially among patients receiving chronic systemic therapies such as antiplatelets, antihypertensives, and chemotherapeutic agents. In India, a growing population of cardiac and cancer patients often presents to general dental practitioners with oral mucosal complaints that are overlooked or mis-attributed.
Aim of the Study: The study aims to determine the prevalence and characteristics of drug-induced oral ulcers and identify commonly implicated drugs. The objectives were to assess the types and symptomatology of the ulcers and their and their treatment.
Methods: A cross-sectional, observational study was conducted for six months in the department of Dentistry, of a tertiary Medical College. 246 adult patients diagnosed with cardiac or cancer conditions receiving systemic pharmacotherapy for one month were included. The patients presenting with oral ulcerative lesions were included. A structured proforma with demographic details, drug history, ulcer characteristics, and pain severity was used supported by Visual Analogue Scale (VAS) to assess the severity of the symptoms. Suspected ADRs were assessed using the WHO-UMC causality scale, and documented using the Indian Pharmacopoeia Commission's PvPI reporting tools. Data was analyzed using SPSS v25.
Results: Preliminary evidence suggested a high frequency of mucosal toxicity with methotrexate, everolimus, ACE inhibitors, and dual antiplatelet therapy. It was anticipated that a substantial proportion of dental practitioners remained unaware of ADR reporting systems, revealing a pharmaco-vigilance gap in dental settings.
Discussion: The integration of pharmaco-vigilance into general dental practice is essential for enhancing drug safety surveillance. Early identification and reporting of oral ADRs can improve interdisciplinary care and reduce the burden of avoidable complications in vulnerable populations. Moreover, routine training in ADR reporting and implementation of clinical decision tools may bolster vigilance among dentists.
Conclusion: The study provided critical insights into the burden, drug patterns, and reporting behavior related to drug-induced oral ulcers in medically complex patients. Findings are expected to inform policy and practice guidelines for strengthening pharmaco-vigilance in dental care systems in India and beyond.
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Dr. D. Kishore
Associate Professor of Dentistry, Viswabharathi Medical College and General Hospital, Penchikalapadu, Kurnool, Andhra Pradesh.
Dr. Md. Suhail
Assistant Professor of Dentistry, Viswabharathi Medical College and General Hospital, Penchikalapadu, Kurnool, Andhra Pradesh.
Dr. D. Shravya
Associate Professor of Pediatrics, Viswabharathi Medical College and General Hospital, Penchikalapadu, Kurnool, Andhra Pradesh.
Dr. S. Abida Ashroff Fathima
Senior Resident in Community Medicine, Viswabharathi Medical College and General Hospital, Penchikalapadu, Kurnool, Andhra Pradesh