1 Volume 2017; Issue 03 Journal of Pharmacovigilance and Pharma- cotherapeutics Research Article Russom M, et al. J Pharmacovigil Pharm Ther: JPPT-114. Toxic Epidermal Necrolysis, Stevens - Johnson syndrome and Ery- thema Multiform associated with Chlorpheniramine Mulugeta Russom 1* , Merhawi Debesai1, Mehari Zeregabr 1 , Filmon Tesfai 2 , Gelila Abrham 3 *1 Eritrean Pharmacovigilance Centre, Ministry of Health, Eritrea 2 National Medicines and Food Administration, Asmara, Eritrea 3 Tesseney Hospital, Tesseney, Eritrea * Corresponding author: Mulugeta Russom, Eritrean Pharmacovigilance Centre, Ministry of Health, Asmara, Eritrea. Tel: +2917197450; Email: satiswt@gmail.com Citation: Russom M, Debesai M, Zeregabr M, Tesfai F, Abrham G (2017) Toxic Epidermal Necrolysis, Stevens - Johnson syn- drome and Erythema Multiform associated with Chlorpheniramine. J Pharmacovigil Pharm Ther: JPPT-114. DOI: 10.29011/JPPT- 114. 100114 Received Date: 24 June, 2017; Accepted Date: 10 July, 2017; Published Date: 15 July, 2017 Abstract Introduction: Stevens - Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Erythema Multiform (EM) are very rare but potentially fatal cutaneous reactions. As of the publication of this case report, the association of Chlorpheniramine and the serious cutaneous reactions EM, SJS and TEN is not documented in literature. However, inthe international adverse drug reaction database (VigiBase) we found a total of 53 cases of EM, SJS, and TEN submitted from different parts of the world in- cluding Eritrea. This case study, based on data retrieved from VigiBase, was therefore aimed at assessing the causal association of TEN, SJS and EM with the use of Chlorpheniramine. Method: Search was made in the VigiBase, using VigiLyze with ‘Chlorpheniramine’, ‘Chlorpheniramine maleate’ and ‘Chlo- rphenamine’ as drug substance and ‘EryhthemaMutiforme’, ‘Stevens-Johnson syndrome’ and ‘Toxic epidermal Necrolysis’ as reactionMedDRA terms. Possible duplicates were eliminated using VigiMatch. Retrieved cases were then subjected to causality assessment using Austin Bradford-Hill criteria. Results: From 1973 to April 2017, a total of 53 serious cutaneous reactions including SJS (26), EM (14), TEN (8) and epider- mal Necrolysis (5) were reported to the global database. Chlorpheniramine was the only suspected drug in 15 of the cases with no concomitants except for one case. The median time to onset was found to be three days and in four of the cases, reaction outcome was marked as ‘fatal’ and in 13 as ‘not yet recovered’. Conclusion: This case series assessment found a suggestive causal association between Chlorpheniramine and the serious cutaneous reactions under discussion. Introduction Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are life-threatening cutaneous reactions mostly manifested with drugs [1-9]; though larger cases of Erythema Mul- tiform (EM) can be explained with certain infections [10]. These serious cutaneous reactions are generally characterized by targe- toid erythematous lesions, epidermal Necrolysis, skin sloughing and detachment that usually involves the trunk, face and mucous membranes including the eyes, genitals and lips with varying de- grees [11]. They are very rare events with an average incidence proportion of one case per million populations per year [2,12]. Chlorpheniramine is used in the symptomatic control of al- lergic conditions which respond to antihistamines including hay fever, urticaria, vasomotor rhinitis, food allergy, drug and serum reactions, pruritus vulvae, pruritus aniand insect bites [13]. As of the publication of this cases report, the association of Chlorphe- DOI: 10.29011/JPPT-114. 100114