Profile of cutaneous adverse drug reactions of carbamazepine

Abstract

Background: Carbamazepine, a commonly used antiepileptic drug is known to produce adverse effects including dangerous reactions like cutaneous hypersensitivity reactions such as drug induced hypersensitivity syndrome (DHS), Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The FDA released a warning that serious and potentially fatal skin reactions may occur after carbamazepine in patients positive for the HLA-B*1502 allele which occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. This study profiles the cutaneous adverse drug reactions reported in this institute over a period of 3 years.Methods: This retrospective study was conducted at Tirunelveli Medical College Hospital by analysing patient case records based on adverse drug reactions reported between August 2014 and July 2017 in the adverse drug reaction monitoring centre. The age, gender, diagnosis, type of cutaneous ADR, duration of treatment, seriousness of reaction and outcome were recorded and analysed.Results: Among the total 25 reactions 36% were benign and 64% were severe reactions. According to Pharmaco vigilance Program of India 80% of the reactions were serious and 20% non serious. The commonest benign skin reaction was maculopapular eruption. SJS and TEN were the two very serious reactions which affected 8 patients totally. Exfoliative dermatitis was reported in 7 patients and Drug Hypersensitivity Syndrome (DHS) in one patient.Conclusions: Severe cutaneous reactions occur after carbamazepine and prevention of ADR requires prediction of predisposition which requires special studies of HLA or genomic assessment. These are the issues of interest for future research.