Table 1.
RUCAM Causality Assessment Tool Assessment for Hepatocellular Injury (R Ratio = 33).
| Assessment | Descriptor | Score |
|---|---|---|
| Time of onset from cessation of the drug | ≤15 d | +1 |
| Course after stopping drug (decrease in ALT between peak value and ULN) | Decrease by ≥50% within 8 d | +3 |
| Risk factors (alcohol and age ≥55) | Patient denies alcohol use and is <55 | 0 |
| Concomitant drugs | Both amiodarone and sotalol stopped >15 d prior to event. Warfarin use has suggestive time of onset but is typically associated with cholestatic injury. | 0 |
| Exclusion of other causes of liver injury | Group I causes: Hepatitis A, B, and C; biliary obstruction, alcoholism, and recent history of hypotension/shock/ischemia ruled out. Group II causes: Complications of underlying autoimmune hepatitis, sepsis, chronic HBV or HCV, primary biliary cirrhosis, sclerosing cholangitis, CMV, EBV, and HSV ruled out. All causes in groups I and II ruled out |
+2 |
| Previous information on hepatotoxicity of the drug | Reaction labeled in product characteristics | +2 |
| Response to readministration | Compatible, dofetilide readministered on day 2 following labs being taken for that day. ALT proceeds to increase and peak on day 5. | +1 |
| Total score: 9 | Interpretation: Scores of 9 or greater imply dofetilide is a “highly probable” cause of liver injury. | |
Note. The Roussel Uclaf Causality Assessment Method (RUCAM) for drug-induced liver injury (DILI). R ratio calculated from alanine aminotransferase (ALT) and alkaline phosphatase (ALK P) values on hospital day 5. Calculation: R ratio = (ALT / ALT ULN) ÷ (ALK P / ALK P ULN), where ALT ULN = 40 and ALK P ULN = 130. CMV = cytomegalovirus; EBV = Epstein-Barr virus; HBV = Hepatitis B Virus; HCV = Hepatitis C Virus; HSV = herpes simplex virus; ULN = Upper Limit of Normal.