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Volume 14 Issue 1 (January) 2025

Original Articles

A prospective study of cutaneous adverse drug reactions at a tertiary care hospital in central India
Dr. Raja Wasim Bakshi, Dr. J L Marko, Dr. Anand Dubey, Dr. Stephen Nand, Dr. Swapnil Mujumdar, Dr. Saman Aatif Saulat, Dr. Tarun Kumar, Dr. Amruthadevi T S

Background: Cutaneous adverse drug reactions (CADRs) encompass a broad spectrum of clinical manifestations ranging from mild erythematous rashes to severe, life-threatening conditions such as Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These reactions pose considerable challenges in clinical practice, particularly in resource-limited settings where early identification, causality assessment, and prompt management can mitigate morbidity and mortality. Methods: A 12-month prospective study was conducted at a tertiary care hospital in Central India. Patients from various departments with clinically suspected CADRs were enrolled after obtaining informed consent and Institutional Ethics Committee approval. Detailed histories—including drug, personal, and family histories—were recorded. Clinical diagnosis was established through expert dermatologist consultation and morphological criteria. Causality was assessed using both the WHO-UMC and Naranjo scales, while severity was analyzed by an adapted Hartwig rating scale. Statistical analysis was performed using descriptive statistics (mean, standard deviation, percentages). Results: A total of 188 patients were evaluated, of which 70 were included in the final analysis based on complete data and confirmed causality assessments. The prevalence of CADRs was slightly higher in males (57.2%). Fixed drug eruption (FDE) emerged as the most common clinical type, followed by erythematous drug eruptions and urticarial reactions. Analgesics/NSAIDs, antibiotics, and corticosteroids were frequently implicated drug groups. Most reactions were of moderate severity (89.9%), while 1.1% were severe. Drug withdrawal, along with appropriate adjunctive therapy, led to recovery or improvement in the majority of cases. Conclusion: CADRs represent a notable source of morbidity in clinical settings, underscoring the need for heightened vigilance, especially with commonly implicated drug classes. Early diagnosis, thorough history-taking, and systematic causality assessments can reduce the risk of severe outcomes. Further large-scale studies are recommended to better characterize CADRs and to improve preventive measures.

 
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