Retrospective analysis of Steven Johnson syndrome and toxic epidermal necrolysis over a period of 5 years from northern Karnataka, India

Naveen, K; Pai, Varadraj V; Rai, Vijetha; Athanikar, Sharatchandra B

doi:10.4103/0253-7613.106441

Cited by 23 publications

(21 citation statements)

References 20 publications

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“…Experiencing serious ADEs in the productive age group of 20-40 years imposes great burden on the patient physically, mentally and economically. Higher prevalence of serious ADEs in 20-40 years age group was also seen in a study by Naveen, et al 13 Male preponderance was observed in the present study, (74%) which was much higher as compared to other studies from Miran Brvar et al from Slovenia in which males constituted 57% of the patients with serious ADEs. 14 In the present study, serious ADEs were caused mainly by Anti epileptic drugs (AED) (32%) followed by Anti HIV drugs and Anti tubercular drugs (18% each).…”

Section: Discussionsupporting

confidence: 78%

Profile of serious adverse drug events in a tertiary care hospital of South India - a five years experience

Jayanthi

Pasha

Sushma

2017

Int J Basic Clin Pharmacol

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Background: Adverse drug event (ADE) is said to be serious, when it is life-threatening, leads to hospitalization, disability, congenital anomaly, death or requires intervention to prevent permanent impairment or damage. The present study aimed to determine the pattern, causality, preventability of serious ADEs.Methods: This retrospective study was carried out to profile serious ADEs reported from Bangalore Medical College and Research Institute to Adverse Drug Reaction (ADR) Monitoring Centre, under Pharmacovigilance Programme of India from 2012 to 2016. Patient demographics, clinical and drug data, details of the ADE, onset time, causal drug details, outcome and severity were collected as per CDSCO form. Causality was assessed by WHO-ADR probability scale, preventability by modified Schumock and Thornton scale.Results: A total of 809 ADEs were reported, of which 50 (6.18%) were serious in nature. Male preponderance (74%) was observed, with 42% among patients aged 20-40 years. 56% of serious ADEs were reported from department of Dermatology. Steven Johnson Syndrome (SJS) (20%) contributed for most of the ADEs. Antiepileptics caused maximum number of serious ADEs (32%). 76% of the ADEs were found to be ‘probable’ and 4% were definitely preventable. 56% of them was life threatening and 86% required intensive interventions. 16% patients experienced serious ADEs during hospital stay.Conclusions: Serious ADEs constituted 6.18% of all ADEs reported. SJS was commonly seen with antimicrobials and hepatotoxicity with ATT. Antiepileptics and ATT contributed for majority of them. This study highlights the importance of monitoring and timely management of serious ADEs to commonly prescribed medications.

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Section: Discussionsupporting

confidence: 78%

Profile of serious adverse drug events in a tertiary care hospital of South India - a five years experience

Jayanthi

Pasha

Sushma

2017

Int J Basic Clin Pharmacol

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“…4 As reported, the rate of occurrence of SJS & TEN to medications is low. 2,5 However, drugs are most commonly implicated for SJS, TEN and SJS-TEN overlap and other possible causes are infections, immunizations, environment chemicals and radiation therapy. 2,5 The incidence of SJS ranges from 1.2 to 6 patients per million per year, while for TEN it ranges from 0.4 to 1.2 patients per million per year.…”

Section: Introductionmentioning

confidence: 99%

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

Lihite¹,

Lahkar²,

Borah³

et al. 2016

JYP

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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 and 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%) and 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 was 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.

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“…3 Steven Johnson Syndrome associated with administration of Ofloxacin had been reported. 4 Similar reactions have been documented with ciprofloxacin and levofloxacin (a L-racemic isomer of ofloxacin). 5 In a systematic review of cutaneous drug reactions on Indian Population Patel et.al.…”

Section: Introductionmentioning

confidence: 60%

Comparative analysis of cutaneous drug reactions among different fluoroquinolones: an experimental study

Devadarshini

Pattnaik

Samal

et al. 2017

Int J Basic Clin Pharmacol

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Background: Fluoroquinolones are generally well tolerated; most adverse effects are mild and common are GI upset. But recent literatures suggest increase reports of Cutaneous Drug reactions (CDRs) including SJS with Fluoroquinolones. However there is insufficient data both in animal and clinical study regarding comparative Analysis of CDRs among different Fluoroquinolones. Hence the present study was under taken to evaluate incidence of comparative CDRs among different Fluoroquinolones.Methods: 96 Albino mice were divided into 16 groups of 6 each. Ciprofloxacin, Ofloxacin, Levofloxacin and Moxifloxacin were administered in Group 1-4, 5-8, 9-12 and 13-16 at the dose of 50/100/150/200mg/kg respectively. The following parameters were observed i.e. Number and % of mice developed CDRs with type and severity. Duration of exposure till development of CDRs, time to Recovery and Mortality in each group.Results: Ofloxacin produced maximum number of CDRs i.e. in 33.3% mice which was significantly higher than that with levofloxacin (p=0.006*). The incidence of CDRs with Ciprofloxacin was 16.67 % and Moxifloxacin16.67 %, but no statistically significant difference than Ofloxacin. The onset for CDRs was significantly earlier with Ofloxacin among the Fluoroquinolones (P=0.013*). The reactions varied from severe dermatitis to serious exfoliation of the skin with ofloxacin and Ciprofloxacin, Alopecia with Moxifloxacin but no cutaneous reactions to Levofloxacin. Mortality was found only with Ofloxacin (12.5%).Conclusions: CDRs are common and may present as severe skin exfoliation or Alopecia with Fluoroquinolones. The CDRs are Maximum with Ofloxacin without significant difference from ciprofloxacin but significantly higher than levofloxacin which has least potential for CDRs. Fatality may occur with Ofloxacin.

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Retrospective analysis of Steven Johnson syndrome and toxic epidermal necrolysis over a period of 5 years from northern Karnataka, India

Cited by 23 publications

References 20 publications

Profile of serious adverse drug events in a tertiary care hospital of South India - a five years experience

Profile of serious adverse drug events in a tertiary care hospital of South India - a five years experience

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

Comparative analysis of cutaneous drug reactions among different fluoroquinolones: an experimental study

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