Table 6.
The updated RUCAM scale for the hepatocellular injury.
| Suspected Product | Date | |
|---|---|---|
| Items for Hepatocellular Injury | Score | Result |
|
1. Time to onset from the beginning of the drug/herb consumption •5–90 days (rechallenge: 1–15 days) •<5 or >90 days (rechallenge: >15 days) Alternative: Time to onset from cessation of the drug/herb •≤15 days (except for slowly metabolized chemicals: >15 days) |
+2 +1 +1 |
□ □ □ |
|
2. Course of ALT after cessation of the drug/herb Percentage difference between ALT peak and ULN •Decrease ≥50% within 8 days •Decrease ≥50% within 30 days •No information or continued drug use •Decrease ≥50% after the 30th day •Decrease <50% after the 30th day or recurrent increase |
+3 +2 0 0 −2 |
□ □ □ □ □ |
|
3. Risk factors •Alcohol use (current drinks/d: >2 for women, >3 for men) •Alcohol use (current drinks/d: ≤2 for women, ≤3 for men) •Age ≥55 years •Age <55 years |
+1 0 +1 0 |
□ □ □ □ |
|
4. Concomitant drug(s)/herb(s) •None or no information •Concomitant drug/herb with incompatible time to onset •Concomitant drug/herb with time to onset 5–90 days •Concomitant drug/herb known as hepatotoxin and with time to onset •5–90 days •Concomitant drug/herb with evidence for its role in this case (positive rechallenge or validated test) |
0 0 −1 −2 −3 |
□ □ □ □ □ |
|
5. Search for alternative causes Group I (7 causes) •HAV: Anti-HAV-IgM •HBV: HBsAg, anti-HBc-IgM, HBV-DNA •HCV: Anti-HCV, HCV-RNA •HEV: Anti-HEV-IgM, anti-HEV-IgG, HEV-RNA •Hepatobiliary sonography/Doppler/CT/MRC •Alcoholism (AST/ALT ≥2) •Acute recent hypotension history (particularly if underlying heart disease) Group II (5 causes) •Complications of underlying disease(s), such as sepsis, metastatic malig-nancy, autoimmune hepatitis, chronic hepatitis B or C, primary biliary cholangitis or sclerosing cholangitis, genetic liver diseases •Infection suggested by PCR and titer change for CMV (anti-CMV-IgM, anti-CMV-IgG) •EBV (anti-EBV-IgM, anti-EBV-IgG) •HSV (anti-HSV-IgM, anti-HSV-IgG) •VZV (anti-VZV-IgM, anti-VZV-IgG) Evaluation of groups I and II •All causes-groups I and II—reasonably ruled out •The 7 causes of group I ruled out •6 or 5 causes of group I ruled out •Less than 5 causes of group I ruled out •Alternative cause highly probable |
Tick if negative □ □ □ □ □ □ □ □ □ □ □ □ +2 +1 0 −2 −3 |
Tick if not done □ □ □ □ □ □ □ □ □ □ □ □ □ □ □ □ □ |
|
6. Previous hepatotoxicity of the drug/herb •Reaction labelled in the product characteristics •Reaction published but unlabelled •Reaction unknown |
+2 +1 0 |
□ □ □ |
|
7. Response to unintentional reexposure •Doubling of ALT with the drug/herb alone, provided ALT below 5 × ULN before reexposure •Doubling of ALT with the drug(s)/herb(s) already given at the time of first reaction •Increase of ALT but less than ULN in the same conditions as for the first administration •Other situations |
+3 +1 −2 0 |
□ □ □ □ |
| Total score of the patient under consideration through combining individual scores: | ||
The above items specifically refer to the hepatocellular injury rather than to the cholestatic and/or mixed liver injury. Squared boxes above require either inclusion of a score related to the patient or a ticking if negative or not done. Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CMV, cytomegalovirus; CT, computer tomography; EBV, Epstein Barr virus; HAV, hepatitis A virus; HBc, hepatitis B core; HBsAg, hepatitis B antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; HEV, hepatitis E virus; HSV, herpes simplex virus; MRC, magnetic resonance cholangiography; RUCAM, Roussel Uclaf Causality Assessment Method; ULN, upper limit of the normal range; VZV, varicella zoster virus. Total score and resulting causality grading: ≤0, excluded; 1–2, unlikely; 3–5, possible; 6–8, probable; ≥9, highly probable. The table was retrieved from an earlier open access publication by Danan and Teschke [201].