An Observational Retrospective Analysis to Study the Clinical and Epidemiological Aspects of Severe Cutaneous Adverse Drug Reactions

Background: Severe cutaneous adverse reactions (SCARs) are rare but potentially life-threatening conditions leading to significant morbidity and mortality. They include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), SJS-TEN complex, acute generalized exanthematous pustulosis (AGEP), and Exfoliative Dermatitis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Objective: To study the clinical and epidemiological aspects of severe cutaneous adverse drug reactions (SCARS). Materials and Methods: A retrospective study at a tertiary care hospital in Western India reviewed SCARs cases from January 2018 to September 2021. Clinical and epidemiological data were extracted using a predesigned pro forma and analyzed. Data from case sheets, clinical charts, and treatment records were reviewed. Causality was assessed using WHO-Uppsala criteria and the Naranjo scale, while SCORTEN criteria evaluated SJS/TEN prognosis. Diagnoses were based on RegiSCAR criteria for DRESS and clinical history for AGEP, Exfoliative dermatitis, SJS, TEN, and SJS/TEN overlap. Investigations included CBC, urine examination, blood sugar, and liver/renal function tests. Key parameters analyzed were patient demographics, culprit drugs, latent period, systemic complications, treatment, and outcomes. Results and Analysis: The study included 13 patients with SCARs, accounting for 0.04% of hospital admissions and 0.13% of dermatology visits. Patients ranged from 6 to 81 years old (mean age 33.1). Diagnoses included seven cases of SJS-TEN complex, 4 of DRESS, 1 of exfoliative dermatitis, and 1 of AGEP. Implicated drugs were antibiotics (30.8%), antiepileptics (23.1%), nonsteroidal anti-inflammatory drugs NSAIDs (15.4%), anti-tuberculosis treatment (ATT) (15.4%), and antiretroviral therapy (ART) (15.4%). Latency between drug intake and symptoms varied between 4 and 33 days. Limitations: There maybe the selection bias or misidentification of certain offending drugs, as re-challenge tests were not performed in any cases due to ethical considerations. Consequently, we can only speculate about the identity of the causative drugs. Conclusion: SCARs impact health significantly, affecting all the ages and often males with SJS/TEN and exfoliative dermatitis. The common triggers are antibiotics, anticonvulsants, NSAIDs, ATT, and ART. Effective management involves early diagnosis, stopping the offending drug, and multidisciplinary care to prevent deterioration and aid recovery.