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DEVAANSH SYNGLE
2nd MBBS
SGRRIM & HS
PATIENT DETAILS
 Patient ID: 1116477
 Treating doctor: Dr Bharti
 Department: Paediatrics
 Patient initials: BR
 Age: 9 yrs
 Sex: Female
 Weight: 27 kg
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
 Steven Johnson Syndrome
DIAGNOSIS
• 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
OTHER DETAILS ABOUT THE
REACTION/PROBLEM
 Date of reaction started- 28/05/2018
 Date of recovery- Recovering
 Seriousness of the reaction - Hospitalization
 Outcomes- Recovering
DETAILS ABOUT THE
SUSPECTED DRUG
 Suspected drug- Azithromycin
 Route- oral
 Frequency- Once daily
 Reasons for using the drug- Fever
DIAGNOSTIC TESTS
 Complete Blood Count (CBC)
 SGOT
 SGPT
 Blood Culture
TREATMENT
 Mucopain gel
 Ointment Kenacort
 Hexidine mouth wash
 Syrup Calpol SOS
 Multi Vitamin injection
 IV fluid N/2 DNS
 Metrogyl
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
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]
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]
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]
Adverse Drug Reaction: Steven Johnson Syndrome

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Adverse Drug Reaction: Steven Johnson Syndrome

  • 2. PATIENT DETAILS  Patient ID: 1116477  Treating doctor: Dr Bharti  Department: Paediatrics  Patient initials: BR  Age: 9 yrs  Sex: Female  Weight: 27 kg
  • 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
  • 4.  Steven Johnson Syndrome DIAGNOSIS
  • 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
  • 8. DIAGNOSTIC TESTS  Complete Blood Count (CBC)  SGOT  SGPT  Blood Culture
  • 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]