Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in vietnamese spontaneous adverse drug reaction database: A subgroup approach to disproportionality analysis.

Abstract

Despite the numerous studies investigating drug-induced Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), the understanding and quantitative data in developing countries remain limited. The study aimed to describe and quantify the drug-related risk of SJS/TEN in a resource-limited context using the Vietnamese spontaneous reporting database (VSRD) of adverse drug reactions. Spontaneous reports relating to medium- and late-onset severe cutaneous adverse reactions (MLOSCAR) and SJS/TEN recorded in the VSRD from 2010 to 2015 were retrospectively analysed. The demographic characteristics and drug information were described and compared between SJS/TEN and other MLOSCAR reports. The drug-induced SJS/TEN signals were estimated using subgrouped disproportionality analysis with calculation of the reporting odds ratio (ROR) and the respective 95% confidence interval (CI). The VSRD received 2,849 MLOSCAR reports, 136 of which focus on SJS/TEN over a 6-year period. About 60% of SJS/TEN patients were male, and the majority of them were adults (mean age 42.5±22.9). Up to 91.8% of drugs induced SJS/TEN within 1-28days, and 45% SJS/TEN cases were evaluated as life-threatening. Positive signals were generated with carbamazepine (n=25, ROR [95% CI]=11.99 [7.07-19.92]), allopurinol (n=15, ROR [95% CI]=4.2 [2.20-7.59]), traditional/herbal medicines (n=7, ROR [95% CI]=2.76 [1.12-5.86]), colchicine (n=4, ROR [95% CI]=6.22 [1.69-18.72]), valproic acid (n=3, ROR [95% CI]=8.71 [1.89-30.19]) and meloxicam (n=3, ROR [95% CI]=7.09 [1.55-24.29]), which are well known for SJS/TEN. Cefixime (n=5, ROR [95% CI]=3.34 [1.13-8.00]) and paracetamol (n=22, ROR [95% CI]=5.23 [3.10-8.49]) also generated positive signals despite their popularity in Vietnam. This first Vietnamese population-based study has highlighted original characteristics and signals of drug-induced SJS/TEN, which are relatively consistent with other worldwide data and typical for a developing country.