IDENTIFICATION OF THE CAUSES OF STEVENS-

JOHNSON SYNDROME ON PATIENTS ADMISSIONS AT

QUEEN ELIZABETH II HOSPITAL: A

PHARMACOVIGILANCE APPROACH

Author: Sebabatso C. Mthakathi

Presenter: Lineo Maja

Faculty of Health Sciences

Department of Pharmacy

INTRODUCTIONStevens-Johnson Syndrome (SJS)

is a serious mucocutaneous illness with systemic symptoms characterized by the presence of flat, atypical target lesions and the epidermal detachment is < 10% of the total body surface area (BSA).1

STEVENS-JOHNSON SYNDROME SJS is a very painful and distressing condition It is also a physically and psychologically

dreadful disease It is an immune complex hypersensitivity

reactions of drugs Some of drugs that may cause SJS include2:

Antibiotics Sulphonamides, e.g. cotrimoxazole Beta-lactams, e.g. penicillins, cephalosporins

Antifungals Imidazole antifungals

Antivirals Nevirapine (NNRTI)

Allopurinol

STEVENS-JOHNSON SYNDROME

Non-steroidal anti-inflammatory drugs (NSAIDS)

Naproxen, ibuprofenAnti-convulsants

Carbamazepine, phenytoin, phenobarbital, valproic acid

It affects both genders of all agesEpidemiology of SJS The reported incidence varies from 1.2

to 6 per million patient-years for SJS.3

STEVENS-JOHNSON SYNDROME The incidence rises with increasing age

and is at least a 1,000-fold higher in patients with HIV/AIDS.3

Regional differences in drug prescription, the genetic background of patients (human leukocyte antigen [HLA], metabolizing enzymes), the co-existance of cancer, or concomitant radiotherapy, can have an impact on the incidence of SJS and toxic epidermal necrolysis (TEN).4

AIM AND OBJECTIVES The aim of the study was to identify

the general causes of SJS

Objective was to identify the following:Drugs which were implicated in SJS

and those which were suspected to have caused SJS

The other causative factorsThe number of deaths associated

with SJS

METHODS A retrospective review of cases of

patients admitted at Queen Elizabeth II hospital with SJS diagnosis was carried out

Data to be captured were for time period of five years

(January 2005 to February 2010) Data from clinical notes/patients’ files

in the Medical Records Department was used

METHODS Pre-designed data collection form

was used to capture data Parameters included:

Demographic informationCausative agents of SJSManagement outcomeDrugs prescribed during

hospitalizationDrugs prescribed during hospital

discharge

METHODS To ensure confidentiality, names of

patients were not used Origin 6.0 statistical package was

used for data analysis Ethical approval was granted by the

Ministry of Health and Social Welfare

RESULTS A total of 31 cases of SJS were seen 81% were females while 19% were

males with ages ranging from 16-64 with the mean age of 33.5 years

Among SJS diagnosed patients;18 (58%) patients were retro viral

disease (RVD) positiveRVD status of the remaining 13

(42%) patients was unknown

RESULTS 76% cases of SJS were drug induced 24% cases of SJS were due to other

causes Nevirapine had the highest incidence

with 10 (34.5%) cases followed by Cotrimoxazole with 6 (20.7%)

Allopurinol and benzyl penicillin both had one incidence of 3.4%

RESULTS There were also other drugs suspected

to have caused SJS:3 cases (10.3%) of SJS were suspected to

have been due to penicillins2 cases (6.9%) due to anti-TB drugs,

isoniazid Conditions suspected to predispose

patients to SJS were:Allergies with the highest incidence of 4Pneumonia with the incidence of 3HIV with the incidence of 2

RESULTS Management outcomes were as follows: 6 deaths were noted (19%) 25 cases (81%) had improved and were

therefore discharged Drugs which were prescribed for

patients and why they were given:Antibiotics- to treat the infectionsTopical corticosteroids- to reduce

inflammationAnalgesics- to alleviate painThymol mouth wash- it has antibacterial

activity Intravenous fluids- for rehydration

CONCLUSION Awareness about the drugs implicated in

life threatening drug reactions will help physicians in preventing them by judicious use of the drugs.

STUDY LIMITATIONS Due to improper filing in the Medical

Records Department, finding study subjects was difficult

Documentation in the patients’ medical files was incomplete

The etiology of SJS was easy to postulate but difficult to prove because there were no skin biopsy done or laboratory tests available, skilful collection of patient histories remained the best tool for identifying a particular drug as the trigger of SJS

RECOMMENDATIONS A careful drug history is especially important

to identify and quickly discontinue possible inciting medications.

Nevirapine (NVP) had the highest incidence of SJS cases as a result, physicians have to consider seriously the risk of these life-threatening cutaneous reactions when prescribing a HAART regimen containing NVP.

When NVP has advantages over other NNRTIs, doctors and pharmacists must inform their patients of the risk of cutaneous reactions and provide clear guidelines of what to do in the case of skin eruptions.

REFERENCES1. Sharma K. V., Sethuraman G. & Minz A. 2008.

Stevens Johnson syndrome, toxic epidermal necrolysis and SJS-TEN overlap: A retrospective study of causative drugs and clinical outcome. Indian journal of dermatology venereology leprology, 74 (3): 238-240

2. Devi K., George S., Criton S. & Suja V., Sridevi P. K. 2005. Carbamazepine- The commonest cause of toxic epidermal necrolysis and Stevens Johnson Syndrome: A study of 7 years. Indian journal of dermatology venerelogy leprology, 71 (5): 325-328.

REFERENCES3. Tan S.-K. & Tay Y.-K. 2012. Profile and

pattern of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in a general hospital in Singapore: Treatment outcomes. Acta Dermato Venereologica, 92: 62-66.

4. Harr T. & French E. L. 2010. Toxic epidermal necrolysis and Stevens-Johnson syndrome. Orphanet journal of rare diseases, 5: 39.

Rea leboha Thank you