Table 1.
| Elements necessary for the diagnostic evaluation of DILI |
| Known duration of exposure |
| Concomitant medications and diseases |
| Response to dechallenge (and rechallenge if performed) |
| Presence or absence of symptoms, rash, eosinophilia |
| Performing sufficient exclusionary tests (viral serology, imaging, etc.) to reflect the injury pattern and acuteness of liver function tests (e.g., acute viral serology for A, B and C and autoimmune hepatitis when presenting with acute hepatocellular injury; routine testing for hepatitis E virus not recommended because of the problems with current commercial assays; Epstein-Barr virus, cytomegalovirus, and other viral serology if lymphadenopathy, atypical lymphocytosis present) |
| Sufficient time to determine clinical outcome - did the event resolve or become chronic? |
| Use of liver biopsy |
| Often not required if the acute injury resolves |
| Helpful in confirming clinical suspicion of DILI but rarely pathognomonic |
| Useful to differentiate between Drug-Induced autoimmune hepatitis and idiopathic autoimmune hepatitis |
| Useful to rule out underlying chronic viral hepatitis, non-alcoholic fatty liver disease, alcoholic liver disease, or other chronic liver disease |
| Used to exclude DILI where re-exposure or ongoing use of an agent is expected |
| Rechallenge: Generally best avoided, unless there is no alternative treatment |
| Use of Causality Assessment Methods |
| Roussel Uclaf Causality Assessment Method is best considered an adjunct to expert opinion (it should not be the sole diagnostic method) |
| Consensus opinion |
| Expert consultation |
| For patients with chronic viral hepatitis, DILI requires a high index of suspicion, knowledge of a stable clinical course before the new medication, and monitoring of viral loads to rule out flares of the underlying disease |
| Assigning causality to herbal compounds and dietary supplements can be especially difficult; require knowledge of all ingredients and their purity |
DILI: Drug-induced liver injury.