Table 2.
Selected reports with questionable causality assessed by LiverTox.
| Drug | LiverTox Category of Case Likelihood |
LiverTox iDILI Case Details, Confounding Variables, Alternative Causes and Comments |
|---|---|---|
| Abacavir | Category C: Probable | HEV, HSV, and VZV infections were not excluded. Comedication with nevirapine, lamivudine, lopinavir. Commentary: Consider better as alternative causes: HEV, HSV, VZV infection, or comedication. |
| Baclofen | Category D: Possible | No details of a specific case provided. No commentary. |
| Cabazitaxel | Category E: Unproven | No details of a specific case provided. No commentary. |
| Dabigatran | Category E: Unproven | No details of a specific case provided. No commentary. |
| Eculizumab | Category D: Possible | A specific case presented without details of exclusion of alternative causes. Small case series without details provided. No commentary. |
| Famciclovir | Category E: Unlikely | No details of a specific case provided. No commentary. |
| Gabapentin | Category C: Probable | No details of a specific case provided. No commentary. |
| Haloperidol | Category B: Highly likely | No details of a specific case provided. No commentary. |
| Ibalizumab | Category E: Unlikely | No details of a specific case provided. No commentary. |
| Ketamine | Category B: Highly likely | Single case, no acute DILI because ketamine was inhaled for 9 months. Tests for HAV, HBV, and HCV were unremarkable, as were those for autoantibodies and Wilson disease. Liver histology was suggestive of primary sclerosing cholangitis (PSC). Commentary: Rather than acute iDILI, PSC is the most likely diagnosis. |
| Labetalol | Category C: Probable | Single case presented with lethal outcome. Patient was negative for hepatitis A and B. No diagnosis was made, and the patient again received at two different occasions of labetalol, leading to lethal ALF. Commentary: Differential diagnosis of ALF poorly assessed. |
| Macitentan | Category E: Unlikely | No details of a specific case provided. No commentary. |
| Nabilone | Category E: NA | No details of a specific case provided. No commentary. |
| Obeticholic acid | Category B: Highly likely | Single case of a patient with PSC lacking exclusion of alternative causes. Commentary: Case is best seen as exacerbation of PSC rather than as acute iDILI. |
| Paclitaxel | Category D: Possible | Single case of a severely ill patient, with previous pelvic radiation and now carboplatin comedication, who experienced a severe hypersensitivity reaction and increased liver tests without assessing alternative causes. Commentary: Poorly documented case of unclear iDILI. |
| Quazepam | Category E: Unlikely | No details of a specific case provided. No commentary. |
| Rabeprazole | Category D: Possible | No details of a specific case provided. No commentary. |
| Safinamide | Category E: Unlikely | No details of a specific case provided. No commentary. |
| Tacrine | Category A: Highly probable | Single case presented, vague exclusion of alternative causes. Commentary: Poorly documented case. |
| Ursodiol | Category D: Possible | No details of a specific case provided. No commentary. |
| Valacyclovir | Category D: Possible | Single case presented of a patient with shingles; tests for hepatitis A, B, and C were negative, as were autoantibodies. Comedication with acetaminophen. Specific note: The possibility of varicella zoster-induced hepatitis should also be considered. Commentary: Increased values of ALT and ALP are best explained by the liver involvement of varicella zoster virus infection and not by iDILI. |
| Warfarin | Category C: Probable | No details of a specific case provided. No commentary. |
| Zafirlukast | Category C: Probable | Case 1: Patient was described as having no risk factors for viral hepatitis. Test for hepatitis A, B, and C were negative, as were autoantibodies, and other parameters to exclude alternative causes were not presented. Commentary: Insufficiently documented case, not allowing for a valid diagnosis.Case 2: Patient was reported as having no history of exposure to viral hepatitis, but details of hepatitis exclusion were not provided. Positive results of unintentional reexposure were described without presenting applied criteria. Commentary: Poorly documented case. |
Listed details were retrieved from an earlier publication [2]. Abbreviations: ALF, acute liver failure; ALP, alkaline phosphatase; ALT, alanine aminotransferase; iDILI, idiosyncratic drug-induced liver injury; NA, not available; PSC, primary sclerosing cholangitis.