Drug induced stevens johnson syndrome and toxic epidermal necrolysis: a study by spontaneous adverse drug reaction reporting system

Stevens Johnson Syndrome (SJS) and Toxic epidermal necrolysis (TEN) are severe adverse cutaneous drug reactions that predominantly involve the skin and mucous membranes. Drugs are most commonly implicated and present study focuses on spontaneous adverse drug reaction reporting of drug induced SJS and TEN by using suspected adverse drug reaction reporting form provided by Pharmacoviglance Program of India (PvPI). Total of 18 adverse drug reactions of SJS, TEN and SJS-TEN overlap reports were collected from Rajiv Gandhi Government General Hospital & Madras Medical College, Chennai from May 2015 to October 2018. Among 18 ADR reports collected, 11 were SJS, 3 were TEN and 4 were SJS-TEN overlap cases. Out of 18 reports, 8 were female patients and 10 were male patients in the age group of 3-19 yrs (F-6, M-1) and 20-60 yrs (F-2, M-9). Total of 22 drugs were the offending drugs and 4 reports were found with multiple drugs and 14 were implicated with single drug. It was found that the most implicated class of drugs were antiepileptic drugs (n=8) followed by NSAIDs (n=4) and antimicrobials (n=2) as single offending drugs. All the reports fall under “probable” category according to WHO-UMC causality assessment scale, all were serious cases and all the patients recovered.