Abstract

OXCARBAZEPINE-INDUCED TOXIC EPIDERMAL NECROLYSIS — A RARE BUT SERIOUS ADVERSE DRUG REACTION: A CASE REPORT

Dr. Likhith J.*, Dr. Mukunda N., Dr. Anuradha H. V.

ABSTRACT

Background: Toxic Epidermal Necrolysis (TEN) is a rare life-threatening mucocutaneous reaction belonging to the spectrum of Severe Cutaneous Adverse Reactions (SCARs). With an annual incidence of 0.4–1.2 cases per million population and a mortality rate of 30–50%, TEN demands early recognition and prompt management. Oxcarbazepine a keto-analog of carbamazepine developed to minimize hypersensitivity reactions, has been rarely implicated in TEN, particularly among carriers of the HLA-B*15:02 allele prevalent in Asian populations. Case Description: A 58-year-old female with known epilepsy and hypertension presented with a 3-day history of high-grade fever, malaise, and a rapidly progressing skin eruption following four weeks of oxcarbazepine 300 mg twice daily therapy. Clinical examination revealed erythematous maculopapular lesions evolving into flaccid bullae with positive Nikolsky’s sign, periorbital edema, conjunctival congestion, and genital mucosal erosions. Oxcarbazepine was immediately withdrawn and targeted pharmacological management was initiated, with complete re-epithelialization within 10 days. ADR Assessment: Causality was rated Probable according to WHO-UMC, severity Level 4b that is Severe according to Modified Hartwig & Siegel and preventability is Not Preventable as per Schumock & Thornton. Conclusion: This case highlights the imperative of HLA-B*15:02 genetic screening before initiating aromatic anticonvulsants in Asian populations, the value of standardized ADR assessment tools, and the critical role of pharmacovigilance reporting to national systems such as PvPI.

Keywords: Toxic Epidermal Necrolysis, Oxcarbazepine, Severe Cutaneous Adverse Reaction, HLA-B*15:02, Pharmacovigilance, Adverse Drug Reaction.