DILIN - Prospective Study

Inclusion criteria

• ✓. ALT or AST \>5 x ULN or A P'ase \>2 x ULN confirmed on at least 2 consecutive blood draws in patients with previously normal values.
• ✓. If baseline (BL) ALT, AST or A P'ase are known to be elevated, then ALT or AST \>5 x BL or A P'ase \>2 x BL on at least 2 consecutive blood draws. "Baseline" is defined as the average of at least 2 measurements performed during the 12-month period prior to starting the DILI medication.
• ✓. Any elevation of ALT, A P'ase, or AST, associated with (a) increased total bilirubin \[ ≥ 2.5 mg/dL\], in absence of prior diagnosis of liver disease, Gilbert's syndrome, or evidence of hemolysis or (b) coagulopathy with INR \> 1.5 in absence of coumadin therapy or known vitamin K deficiency.