Abstract

EXPLORING FIXED DRUG ERUPTION: UNRAVELING CLINICAL PATTERNS, CULPRIT DRUGS, AND RECURRENCE RISK—EVIDENCE FROM A PROSPECTIVE STUDY IN A NORTH INDIAN TERTIARY CARE CENTER

Dr. Ankit Kumar*, Prof. Devendra Katiyar, Prof. Parul Verma, Dr. Sagar Agarwal

ABSTRACT

Background: Fixed drug eruption (FDE) is a distinctive form of cutaneous adverse drug reaction characterized by recurrence of lesions at the same anatomical site upon re-exposure to the offending drug. Despite being a common adverse cutaneous drug reaction, data regarding clinical patterns, causative medications and recurrence characteristics from North India remain limited. Aim: To evaluate the clinical characteristics, causative drugs and recurrence patterns of fixed drug eruption in patients attending a tertiary care teaching hospital. Materials and Methods: A prospective observational study was conducted over one year in collaboration between the Departments of Pharmacology and Dermatology at King George's Medical University, Lucknow. Thirty-two clinically diagnosed FDE patients fulfilling inclusion criteria were enrolled after obtaining informed consent. Demographic characteristics, lesion morphology, anatomical distribution, causative drugs, latency period, recurrence pattern and causality assessment were recorded. Causality was assessed using the Naranjo ADR Probability Scale and WHO-UMC causality assessment system. Data were analyzed using descriptive statistics. Results: Thirty-two patients were included in the study. The majority belonged to the 18–45-year age group (68.8%) and males constituted 65.6% of patients. Patch-type FDE was the most common clinical presentation (50%), followed by macular (21.9%) and bullous variants (21.9%). The trunk and extremities were the most commonly involved anatomical sites. Fixed drug combination fixed drug combination antibiotics were the most frequent causative drug group (50%), followed by NSAIDs (21.9%). Recurrence at the same anatomical site was observed in 63.2% of recurrent cases. Residual hyperpigmentation was present in all patients. Most cases were mild and no life-threatening outcomes were observed. Conclusion: FDE predominantly affects young adult males and is commonly associated with antimicrobial agents and NSAIDs. Recognition of characteristic recurrence patterns and prompt withdrawal of culprit drugs remain essential for prevention of repeated episodes.

Keywords: Fixed Drug Eruption; Cutaneous Adverse Drug Reaction; Fluoroquinolones; Fixed drug combinations; Pharmacovigilance; Naranjo Scale, WHO-UMC Scale.