3. DESCRIBING THE
PROBLEM
Erosive lesions in the oral cavity with
multiple crusted lesions seen over the
lips
Fever
Rash
Pain in abdomen
Patient had been treated with oral
Azithromycin
5. • STEVENS-JOHNSON SYNDROME and TOXIC
EPIDERMAL NECROLYSIS ( SJS TEN)
• Characterized by blisters and epidermal
detachment resulting from epidermal necrosis
• SJS or TEN have no treatment of proven
efficacy.
• Best results come from early diagnosis,
immediate discontinuation of any suspected
drug and supportive therapy
6. OTHER DETAILS ABOUT THE
REACTION/PROBLEM
Date of reaction started- 28/05/2018
Date of recovery- Recovering
Seriousness of the reaction - Hospitalization
Outcomes- Recovering
7. DETAILS ABOUT THE
SUSPECTED DRUG
Suspected drug- Azithromycin
Route- oral
Frequency- Once daily
Reasons for using the drug- Fever
9. TREATMENT
Mucopain gel
Ointment Kenacort
Hexidine mouth wash
Syrup Calpol SOS
Multi Vitamin injection
IV fluid N/2 DNS
Metrogyl
10. Description according to NARANJO SCALE
1. Are there previous conclusive reports on this
reaction?
2. Did the adverse event appear after the suspected
drug was given ?
3. Did the adverse reaction improve when the drug
was discontinued or a specific antagonist was given
?
4. Did the adverse reaction appear when the drug was
re-administered ?
5. Are there alternative cause that could have caused
the reaction ?
6. Did the reaction reappear when a placebo was given
?
Yes
+1
+2
+1
+2
-1
-1
No
0
-1
0
-2
+2
+1
Don’t
know
0
0
0
0
0
0
Scor
e
+1
+2
+1
0
+2
0
11. DESCRIPTION
7 . Was the drug detected in any body fluid in toxic
concentration ?
8. Was the reaction more severe when the dose was
increased or less severe when the dose was
decreased ?
9. Did the patient have similar reaction to the same
or similar drugs in any previous exposure ?
10. Was the adverse event confirmed by any
objective evidence ?
ADR SCORE
YES
+1
+1
+1
+1
NO
0
0
0
0
DON’T
KNOW
0
0
0
0
SCORE
0
0
0
0
6
• Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et
al. A method for estimating the probability of adverse drug
reactions. Clin Pharmacol Ther. 1981;30:239–45. [PubMed]
12. PROBABLE/ LIKELY
•Event or laboratory test abnormality , with
reasonable time relationship to drug intake .
•Unlikely to be attributed to disease or other
drugs .
•Response to withdrawal clinically reasonable
•Re challenge not required .
WHO – UMC CAUSALITY
CATEGORIES
• The use of the WHO–UMC system for standardised case causality
assessment. Accessed from: http://www.WHO-
UMC.org/graphics/4409.pdf {last accessed on 2011 Feb 12]
13. REFERNCES
• Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I,
Roberts EA, et al. A method for estimating the probability
of adverse drug reactions. Clin Pharmacol Ther.
1981;30:239–45. [PubMed]
• The use of the WHO–UMC system for standardised
case causality assessment. Accessed from:
http://www.WHO-UMC.org/graphics/4409.pdf
{last accessed on 2011 Feb 12]