Home J Young Pharm, Vol 8/Issue 2/2016 A study on drug induced Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and SJS-TEN overlap in a tertiary care hospital of Northeast India

A study on drug induced Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and SJS-TEN overlap in a tertiary care hospital of Northeast India

by [email protected]
Published on:January 2016
Journal of Young Pharmacists, 2016; 8(2):149-153
Short Communication | doi:10.5530/jyp.2016.2.18
Authors:
Ratan J. Lihite,1 Mangala Lahkar,2 Ajoy Borah,3 Debeeka Hazarika,4 Sukhjinder Singh51Department of Pharmacology, ADR Monitoring Centre (Pharmacovigilance Programme of India, IPC-NCC, Ministry of Health & Family welfare, GoI), Gauhati Medical College & Hospital, Guwahati-781032, Assam, INDIA.

2Department of Pharmacology & NIPER-Guwahati,  Gauhati Medical College & Hospital, Guwahati-781032, Assam, INDIA.

3Department of Pharmacology, Gauhati Medical College & Hospital, Guwahati-781032, Assam, INDIA.

4Department of Dermatology & STD, Gauhati Medical College & Hospital, Guwahati-781032, Assam, INDIA.

5Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER) (Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, GoI), Guwahati-781032, Assam, INDIA.

Abstract: Background: Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and SJS-TEN overlap are rare, but potentially life-threatening, reactions to medications. From Northeast India, limited epidemiological data is available on these cutaneous drug reactions. Aims: The purpose of this study was to assess the drug-induced SJS/TEN cases of a tertiary care hospital of Northeast India. Methods: This cross sectional study was conducted in Gauhati Medical College & Hospital of Guwahati city, Northeast India. WHO–UMC probability assessment system and ALDEN were used for causality assessment of reported SJS/TEN cases. Results are presented in percentage; mean (standard deviation), and median (interquartile range difference). Results: Forty five cases of drug induced SJS (42.22%), TEN (55.55%) & SJS-TEN (2.22%) overlap were reported. Out of these, 25 patients were males and 20 patients were females. The mean age of the patients was 29.69 (17.57) year. The median time duration between drug intake and onset of symptoms for SJS/TEN was 25(4) and the median duration of hospital stay by patients was 13(8). The most offending groups of drugs were antimicrobials (35.55%), followed by anticonvulsants (28.89%), antipyretics (17.78%), and nonsteroidal anti-inflammatory drugs (6.67%). In individual drug category, paracetamol (17.77%) & phenytoin (15.55%) were among the commonly reported offending drugs. Altered liver function test was commonly reported complication in SJS/TEN patients. As per ALDEN, drug causality was very probable in 16 cases whereas by WHO-UMC assessment system, 1 case was certain while 29 cases were probable. Limitations: Statistical significance among the variables has not shown and large study sample may be required for interpretation of results to arrive at a definite conclusion. Conclusions: Antimicrobials, anticonvulsants, and antipyretics were commonly reported group of offending drugs to cause SJS/TEN in patients. Paracetamol & phenytoin were commonly reported individual offending drugs.

Key words:  SJS, TEN, Northeast India, Paracetamol, Anticonvulsants, Offending drugs