Case Report
Copyright ©The Author(s) 2019.
World J Hepatol. Nov 27, 2019; 11(11): 735-742
Published online Nov 27, 2019. doi: 10.4254/wjh.v11.i11.735
Table 3 The Council of International Organizations of Medical Sciences and Roussel Uclaf Causality Assessment Method Scale
CriteriaScore
Time from drug intake until reaction onset
5-90 d+2
< 5 or > 90 d+1
Time from drug withdrawal until reaction onset
< 15 d+1
> 15 d0
Alcohol risk
Present+1
Absent0
Age
> 55 yr+1
< 55 yr0
Course of reaction
> 50% improvement within 8 d+3
> 50% improvement within 30 d+2
Worsening or < 50% improvement in 30 d-1
Concomitant therapy
Time to onset incompatible0
Time to onset compatible but with unknown reaction-1
Time to onset compatible but known reaction Role proved in the case-2 -3
None or information not available0
Exclusion of non-drug related causes
Ruled out+2
Possible or not investigated0
Probable-3
Previous information on hepatotoxicity
Reaction unknown0
Reaction published but unlabeled+1
Reaction labeled in the product’s characteristics+2
Response to re-administration
Positive+3
Compatible+2
Negative-2
Not available or not interpretable0
Plasma concentration of drug known as toxic+3
Validated laboratory test with high specificity, sensitivity, and predictive values positive+3
Validated laboratory test with high specificity, sensitivity, and predictive values negative-3
Interpretation of score for drug induced liver injury:
> 8 definite drug induced liver injury
6-8 probable drug induced liver injury
3-5 Possible drug induced liver injury
1-2 Unlikely drug induced liver injury
< 0 drug induced liver injury excluded