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Common Drug-induced Liver
Injury in Children
Harshad Devarbhavi, MD, DM.
Prof & Head: Gastroenterology
St. John’s Medical College Hospital, Bangalore
Vignette 1
• Fifteen year old girl
• Headache, vomiting, neck-rigidity,
seizures
• CSF: Cells 8, Proteins 45, Glucose: 64
• Empirical Rx with 4-drug ATD
• Five days later: Vomiting increased,
onset of encephalopathy
T. proteins 6.9 6.6
Albumin 3.6 3.2
T. Bilirubin 1.1 4.2
D. Bilirubin 0.5 3.6
AST 30 155
ALT 28 237
ALP 120 104
GGT 43 134
Patient I
T.Proteins 6.9 6.6 5.9
Albumin 3.6 3.2 2.3
T. Bilirubin 1.1 4.2 9
D. Bilirubin 0.5 3.6 7
AST 30 155 1212
ALT 28 237 1456
ALP 120 104 123
GGT 43 134 112
Patient I
INR 4.6
Labs, imaging
• HAV –ve
• HBV –ve
• HCV –ve
• HEV –ve
• ANA –ve
• SMA –ve
• LKM -ve
• USG: CBD 4 mm,
• Liver 9 cm, spleen 7cm,
no ascites
• Child died 12 days after admission
due to hyper acute liver failure
Vignette 2
• Two year 7 month old girl, 11 kg
• 4-drug ATT 2 months
• Jaundice 20 days
• Irritability, altered sleep pattern, grade
III coma, 15 days
• ATT given for LRTI
Common drug induced liver injury in children -dr.  harshad devarbhai
• T. bilirubin 11.6 18.8
• D. bilirubin 7 11.0
• AST 1290 178
• ALT: 860 273
• PT/INR >3`/11
• HAV,HBV,HCV,HEV,HIV: negative
Child died 8 days
after admission
Reports of DILI in children are
rare
• Children constitute 8.7% patients with
DILI
• DILIN 5-7%
• Spain 4%
Common drug induced liver injury in children -dr.  harshad devarbhai
Common drug induced liver injury in children -dr.  harshad devarbhai
Common drug induced liver injury in children -dr.  harshad devarbhai
SJMCH
(1)
DILIN (2) Spain (3) VIGIBASE
(4)
N=39 N=30 N=36 6595
ATT=22
Dapsone=4
TMP SMX=1
Ciprofloxacin=1
Augmentin=1
Minocycline=4
Azithro=3
Amoxicillin=2
Oxacillin=1
Levofloxacin=1
SMX=1
Augmentin=11
ATT=4
Meropenem=4
Cloxacillin=1
TMP SMX=1
Amoxicillin=1
Minocyclin=117
Ceftriaxone=104
Azithromycin=63
Erythromycin=60
TMP SMX=48
Amoxicillin=38
Clarithromy=35
1. Devarbhavi H. Hepatology 2011
2. Molleston JP. JPGN 2011
3. Hita E O. Annales de Pediatria 2013
4. Ferrajolo C. Br J Clin Pharmacol 2010
Common drug induced liver injury in children -dr.  harshad devarbhai
Recent Drugs Implicated in
DILI in Children
• Amiodorone
• Propylthiouracil
• Montelukast
• TMP-SMX
• MTX
• Fondoparinux
• Herbals
Common drug induced liver injury in children -dr.  harshad devarbhai
Devarbhavi H and Andrade R. Sem Liv Dis 2014
Devarbhavi H and Andrade R. Sem Liv Dis 2014
Pediatric DILI
• Rare cause of acute and chronic liver disease
• Can cause asymptomatic elevation of liver
tests, chronic liver disease and ALF
• Acetaminophen common in west, ATT in
India
• Data are sparse in terms of clinical
characteristics and outcome
• Children, intrinsically to be at low risk
for DILI
– Absence of comorbidities
– Differential susceptibilities to certain
drugs
– Medications given for a shorter time
• Challenges:
– fixed drug, weight based or surface based
formulation,
– immaturity of metabolizing enzyme,
– lack of awareness of DILI
Pediatric DILI-ALF
• In a multicenter study of 348 children
with ALF in the US, PCT toxicity in 48
(14%)
• Idiosyncratic DILI in 5%
• Valproate (3), INH (2), and one each of
bactrim, cytoxan/dilantin, dilantin, iron,
minocycline, MTX
Squires Jr. RH. J Pediatrics 2006;148:652-658
Drug-related hepatotoxicity and
acute liver failure
• Twenty percent of ALF in children
• Entire spectrum: hepatitis,cholestasis,
“transaminitis”
• Potential for progression to ALF
• Most common cause of DILI-ALF is
paracetamol 15%, others (ATT/AED-
5%)
Drug Adults Children Recovery
APAP 39% 14% 94%
Non-APAP 13% 5% 5%
Drug-induced ALF
Squires Jr. RH. J Pediatrics 2006;148:652-658
Children vs adults:
pharmacokinetic and adverse –
effect differences
• In children, cytochrome P450 (CYP)-
catalyzed metabolism is increased
• UDP glucoronosyl transferase
catalyzed metabolism is not different
from adults
• Children often receive higher mg/kg
dose compared to adults
Valproate Hepatotoxicity: Risk
Factors
• Age < 3 years
• Patients on polytherapy
• Patients with development delay
• Mortality decreasing with rational
prescribing including monotherapy
Dreifuss FE. Neurology 1987;37:379-85
Scheffner D. Epilepsia 1988;29:530-42
Dreifuss FE. Neurology 1989;39:201-7
Valproate hepatotoxicity
• Occurs in children with pre-existing
mitochondrial disease or IEM
• VPA inhibition of beta-oxidation and
toxicity from VPA metabolites
• Infants and children have higher
concentration ratio of metabolites
• Polytherapy with enzyme inducers
increases formation of hepatotoxic
metabolites
Metabolism of antiepileptic drugs
(AED): newborn to elderly
• In general metabolic rates are fastest in children;
AED half-lives are short
• Children need larger doses on mg/kg basis than
adults
– phenytoin dosage in adults is 4-6 mg/kg, but children
need a dosage 3-5 times higher. Elderly 3-4 mg/kg
• Likewise half life of CBZ is shortest in children
and elderly
• Amount of VPA metabolized to 4-ene is > 2 fold
higher in children than adults, which may explain
the different profile of hepatotoxicity seen by age.
Epilepsia 1992;33:S32-40
DILI
• Patterns
– Acute Hepatitis
– Chronic Hepatitis
– Acute cholestasis
– Mixed
– Chronic cholestasis
– NASH
– Fibrosis/cirrhosis
– Microvesicular fatty
– VOD
– Peliosis hepatis
– Adenoma
• Drugs
– AED, PCT, INH, ATT
– Nirofurantoin
– Amoxicillin-Clavulinate
– Phenytoin, sulfonamides
– CPZ
– Amiodarone
– Methotrexate
– NRTI
– Cyclophosphamide
– AZT
– Hormones
Hepatotoxicity Spectrum
Fulminant Hepatitis - Hepatic FailureFulminant Hepatitis - Hepatic Failure
Reversible Clinical Drug
Induced Liver Injury
Asymptomatic
>5x ULN ALT/AST
Asymptomatic
≤ 5x ULN ALT/AST
Background noise:
HBV/HIV infections,
con-meds,
Acute vital hepatitis: 14.7%
How is hepatotoxicity defined?
Grade 3 toxicity
Grade 4 toxicity
Normal
Grade 1 or 2 toxicity
ALT or AST level
(# of times upper limit
of normal)
1
5
10
0
ULN →
“Severe
hepatotoxicity”
RUCAM Causality Assessment
• Temporal relationship
• Course
• Risk factors
• Concomitant drug
• Nondrug causes
• Previous information
• Rechallenge
RUCAM
• Highly probable >8
• Probable: 6-8
• Possible: 3-5
• Unlikely: 1-2
• Excluded: <0
Comparison of
mechanisms of toxicity
Basis for Injury Experimental
reproducibility
Dose
dependence
Incidence
in humans
Latent
Period
Intrinsic
hepatotoxicity
Yes Yes High Often
short,
relatively
consistent
Idiosyncratic
reaction
No
No
Low Often
long and
variable
Idiosyncratic Hepatotoxicity
Basis for Injury Onset Dose
dependence
Rash, fever,
eosinophilia
Rechallenge
Hypersensitivity
hepatotoxicity
1-5 wk no ++ Rapid +ve
Metabolic
hepatotoxicity
2-52 wk No _ variable
INH-ALF in children
(Wu SS etal. Transplantation 2007;27:173-9)
• 1987-1997, 84 U.S. centers
• 20 cases
• Spontaneous recover 20%, 10 (50%)
OLT, 6 (20%) died awaiting OLT
• Mean age:9.8 y, Duration of INH 3.3 M
• Notably 5 patients with symptoms of
hepatitis were initially told not to stop
treatment
Incidence of clinical hepatitis
• Children
–INH+RIF = 6.9%*
–INH+RIF+PYZ= 7%**
• Adults
–2.7%*
*Steele Chest 1991
**Roy B JGH 2006
Antituberculosis drugs and
their discoveries
• Streptomycin 1944
• Isoniazid 1952
• Pyrazinamide 1952
• Ethambutol 1961
• Rifampicin 1966
• Fluroquinolone 1980
Lessons
• Think drugs at all times
• Drugs have signature pattern
• Stop drugs to minimize
morbidity
Enhanced awareness of DILI,
of commonly prescribed
medications may minimize the
frequency of serious
hepatotoxicity and ALF in
pediatric patients
Treatment
• Prompt discontinuation
• N-acetyl cysteine for ATT-DILI
• Steroids for DRESS
• L- Carnitine for Valproate DILI
Thank you

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Common drug induced liver injury in children -dr. harshad devarbhai

  • 1. Common Drug-induced Liver Injury in Children Harshad Devarbhavi, MD, DM. Prof & Head: Gastroenterology St. John’s Medical College Hospital, Bangalore
  • 2. Vignette 1 • Fifteen year old girl • Headache, vomiting, neck-rigidity, seizures • CSF: Cells 8, Proteins 45, Glucose: 64 • Empirical Rx with 4-drug ATD • Five days later: Vomiting increased, onset of encephalopathy
  • 3. T. proteins 6.9 6.6 Albumin 3.6 3.2 T. Bilirubin 1.1 4.2 D. Bilirubin 0.5 3.6 AST 30 155 ALT 28 237 ALP 120 104 GGT 43 134 Patient I
  • 4. T.Proteins 6.9 6.6 5.9 Albumin 3.6 3.2 2.3 T. Bilirubin 1.1 4.2 9 D. Bilirubin 0.5 3.6 7 AST 30 155 1212 ALT 28 237 1456 ALP 120 104 123 GGT 43 134 112 Patient I INR 4.6
  • 5. Labs, imaging • HAV –ve • HBV –ve • HCV –ve • HEV –ve • ANA –ve • SMA –ve • LKM -ve • USG: CBD 4 mm, • Liver 9 cm, spleen 7cm, no ascites
  • 6. • Child died 12 days after admission due to hyper acute liver failure
  • 7. Vignette 2 • Two year 7 month old girl, 11 kg • 4-drug ATT 2 months • Jaundice 20 days • Irritability, altered sleep pattern, grade III coma, 15 days • ATT given for LRTI
  • 9. • T. bilirubin 11.6 18.8 • D. bilirubin 7 11.0 • AST 1290 178 • ALT: 860 273 • PT/INR >3`/11 • HAV,HBV,HCV,HEV,HIV: negative
  • 10. Child died 8 days after admission
  • 11. Reports of DILI in children are rare • Children constitute 8.7% patients with DILI • DILIN 5-7% • Spain 4%
  • 15. SJMCH (1) DILIN (2) Spain (3) VIGIBASE (4) N=39 N=30 N=36 6595 ATT=22 Dapsone=4 TMP SMX=1 Ciprofloxacin=1 Augmentin=1 Minocycline=4 Azithro=3 Amoxicillin=2 Oxacillin=1 Levofloxacin=1 SMX=1 Augmentin=11 ATT=4 Meropenem=4 Cloxacillin=1 TMP SMX=1 Amoxicillin=1 Minocyclin=117 Ceftriaxone=104 Azithromycin=63 Erythromycin=60 TMP SMX=48 Amoxicillin=38 Clarithromy=35 1. Devarbhavi H. Hepatology 2011 2. Molleston JP. JPGN 2011 3. Hita E O. Annales de Pediatria 2013 4. Ferrajolo C. Br J Clin Pharmacol 2010
  • 17. Recent Drugs Implicated in DILI in Children • Amiodorone • Propylthiouracil • Montelukast • TMP-SMX • MTX • Fondoparinux • Herbals
  • 19. Devarbhavi H and Andrade R. Sem Liv Dis 2014
  • 20. Devarbhavi H and Andrade R. Sem Liv Dis 2014
  • 21. Pediatric DILI • Rare cause of acute and chronic liver disease • Can cause asymptomatic elevation of liver tests, chronic liver disease and ALF • Acetaminophen common in west, ATT in India • Data are sparse in terms of clinical characteristics and outcome
  • 22. • Children, intrinsically to be at low risk for DILI – Absence of comorbidities – Differential susceptibilities to certain drugs – Medications given for a shorter time • Challenges: – fixed drug, weight based or surface based formulation, – immaturity of metabolizing enzyme, – lack of awareness of DILI
  • 23. Pediatric DILI-ALF • In a multicenter study of 348 children with ALF in the US, PCT toxicity in 48 (14%) • Idiosyncratic DILI in 5% • Valproate (3), INH (2), and one each of bactrim, cytoxan/dilantin, dilantin, iron, minocycline, MTX Squires Jr. RH. J Pediatrics 2006;148:652-658
  • 24. Drug-related hepatotoxicity and acute liver failure • Twenty percent of ALF in children • Entire spectrum: hepatitis,cholestasis, “transaminitis” • Potential for progression to ALF • Most common cause of DILI-ALF is paracetamol 15%, others (ATT/AED- 5%)
  • 25. Drug Adults Children Recovery APAP 39% 14% 94% Non-APAP 13% 5% 5% Drug-induced ALF Squires Jr. RH. J Pediatrics 2006;148:652-658
  • 26. Children vs adults: pharmacokinetic and adverse – effect differences • In children, cytochrome P450 (CYP)- catalyzed metabolism is increased • UDP glucoronosyl transferase catalyzed metabolism is not different from adults • Children often receive higher mg/kg dose compared to adults
  • 27. Valproate Hepatotoxicity: Risk Factors • Age < 3 years • Patients on polytherapy • Patients with development delay • Mortality decreasing with rational prescribing including monotherapy Dreifuss FE. Neurology 1987;37:379-85 Scheffner D. Epilepsia 1988;29:530-42 Dreifuss FE. Neurology 1989;39:201-7
  • 28. Valproate hepatotoxicity • Occurs in children with pre-existing mitochondrial disease or IEM • VPA inhibition of beta-oxidation and toxicity from VPA metabolites • Infants and children have higher concentration ratio of metabolites • Polytherapy with enzyme inducers increases formation of hepatotoxic metabolites
  • 29. Metabolism of antiepileptic drugs (AED): newborn to elderly • In general metabolic rates are fastest in children; AED half-lives are short • Children need larger doses on mg/kg basis than adults – phenytoin dosage in adults is 4-6 mg/kg, but children need a dosage 3-5 times higher. Elderly 3-4 mg/kg • Likewise half life of CBZ is shortest in children and elderly • Amount of VPA metabolized to 4-ene is > 2 fold higher in children than adults, which may explain the different profile of hepatotoxicity seen by age. Epilepsia 1992;33:S32-40
  • 30. DILI • Patterns – Acute Hepatitis – Chronic Hepatitis – Acute cholestasis – Mixed – Chronic cholestasis – NASH – Fibrosis/cirrhosis – Microvesicular fatty – VOD – Peliosis hepatis – Adenoma • Drugs – AED, PCT, INH, ATT – Nirofurantoin – Amoxicillin-Clavulinate – Phenytoin, sulfonamides – CPZ – Amiodarone – Methotrexate – NRTI – Cyclophosphamide – AZT – Hormones
  • 31. Hepatotoxicity Spectrum Fulminant Hepatitis - Hepatic FailureFulminant Hepatitis - Hepatic Failure Reversible Clinical Drug Induced Liver Injury Asymptomatic >5x ULN ALT/AST Asymptomatic ≤ 5x ULN ALT/AST Background noise: HBV/HIV infections, con-meds, Acute vital hepatitis: 14.7%
  • 32. How is hepatotoxicity defined? Grade 3 toxicity Grade 4 toxicity Normal Grade 1 or 2 toxicity ALT or AST level (# of times upper limit of normal) 1 5 10 0 ULN → “Severe hepatotoxicity”
  • 33. RUCAM Causality Assessment • Temporal relationship • Course • Risk factors • Concomitant drug • Nondrug causes • Previous information • Rechallenge
  • 34. RUCAM • Highly probable >8 • Probable: 6-8 • Possible: 3-5 • Unlikely: 1-2 • Excluded: <0
  • 35. Comparison of mechanisms of toxicity Basis for Injury Experimental reproducibility Dose dependence Incidence in humans Latent Period Intrinsic hepatotoxicity Yes Yes High Often short, relatively consistent Idiosyncratic reaction No No Low Often long and variable
  • 36. Idiosyncratic Hepatotoxicity Basis for Injury Onset Dose dependence Rash, fever, eosinophilia Rechallenge Hypersensitivity hepatotoxicity 1-5 wk no ++ Rapid +ve Metabolic hepatotoxicity 2-52 wk No _ variable
  • 37. INH-ALF in children (Wu SS etal. Transplantation 2007;27:173-9) • 1987-1997, 84 U.S. centers • 20 cases • Spontaneous recover 20%, 10 (50%) OLT, 6 (20%) died awaiting OLT • Mean age:9.8 y, Duration of INH 3.3 M • Notably 5 patients with symptoms of hepatitis were initially told not to stop treatment
  • 38. Incidence of clinical hepatitis • Children –INH+RIF = 6.9%* –INH+RIF+PYZ= 7%** • Adults –2.7%* *Steele Chest 1991 **Roy B JGH 2006
  • 39. Antituberculosis drugs and their discoveries • Streptomycin 1944 • Isoniazid 1952 • Pyrazinamide 1952 • Ethambutol 1961 • Rifampicin 1966 • Fluroquinolone 1980
  • 40. Lessons • Think drugs at all times • Drugs have signature pattern • Stop drugs to minimize morbidity
  • 41. Enhanced awareness of DILI, of commonly prescribed medications may minimize the frequency of serious hepatotoxicity and ALF in pediatric patients
  • 42. Treatment • Prompt discontinuation • N-acetyl cysteine for ATT-DILI • Steroids for DRESS • L- Carnitine for Valproate DILI