Table 5.
Proposals |
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1. Clinicians, as potential authors of RUCAM-based iDILI case reports, should be encouraged to submit their case reports directly to LiverTox. 2. Additional RUCAM-based iDILI cases should be retrieved from existing iDILI registries of various countries or regions [10], including, for example, Sweden [25], Iceland [30], Spain [24], and Latin America [31], all of which collect iDILI cases using a prospective approach. 3. Other RUCAM-based iDILI cases should be selected from the 81,856 cases published from 1993 to mid-2020 [26]. 4. From now on, the prerequisites for iDILI cases to be included in the LiverTox database and website should be: ● Liver injury must be defined as ALT higher than 5 × ULN (upper limit of normal) and/or ALP higher than 2 × ULN [12,27]; ● An informative case narrative with complete diagnostic and clinical details [27]; ● The R ratio must be calculated based on ALT and ALP values in order to classify the case as hepatocellular injury or cholestatic/mixed liver injury [27]; ● The case should be assessed with the updated RUCAM [27], and the final score should be provided. |
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; iDILI, idiosyncratic drug-induced liver injury; RUCAM, Roussel Uclaf Causality Assessment Method; ULN, upper limit of normal.