P25 Pharmacovigilance assessment of Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) with antibacterial drugs using FDA adverse event reporting system data

Abstract Background Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe and potentially life-threatening skin reactions associated with certain medications, including antibacterial drugs. This study outlines a comprehensive pharmacovigilance study using the US FDA Adverse Event Reporting System (FAERS) data to assess this association. Methods All SJS/TEN cases of antibacterial drugs as primary suspected drugs were extracted from the US FDA FAERS from 2004 to 2023. Descriptive analyses were performed to evaluate the prevalence of SJS/TEN among antibacterial drug users. Disproportionate analyses were conducted by estimating the reporting odds ratio (ROR) and the information component (IC). Results Out of a total of 38 185 cases of SJS/TEN reported in the FAERS, 16 104 (42.17%) cases are due to antibacterial drug use suspects. 332 cases of SJS/TEN overlap from the year 2019 reported. Gender analysis of SJS/TEN shows females (51.2%) are more prone than males (39.29%) and not specified (9.51%). Mortality rate of SJS/TEN due to drug adverse reaction is 21% (7995). The SJS/TEN signal was detected majorly in cotrimoxazole, amoxicillin, ciprofloxacin, vancomycin, levofloxacin, piperacillin sodium/tazobactam sodium, amoxicillin/clavulanate potassium and clarithromycin. The ROR (95% CI) of cotrimoxazole, amoxicillin, ciprofloxacin, vancomycin, levofloxacin, piperacillin sodium/tazobactam sodium, amoxicillin/clavulanate potassium and clarithromycin were 53.74 (57.62–50.12), 0.67 (0.72–0.63), 0.54 (0.58–0.50), 0.85 (0.91–0.79), 0.30 (0.32–0.27), 0.89 (0.96–0.82), 11.27 (12.39–10.25) and 0.50, (0.55–0.46), respectively. Conclusions This pharmacovigilance assessment of FAERS shows 42.17% association of antibacterial drugs in suspected cases of SJS/TEN. This reminds the medical workers to pay attention to the severe adverse effects of antibacterial drugs leading to SJS/TEN.