Biomarkers for the diagnosis and management of drug-induced liver injury.

There is a pressing need for new clinical tests that will help physicians distinguish drug-induced liver injury (DILI) from other, more common causes of liver injury, and that can identify which specific drug is the culprit when DILI occurs in the setting of polypharmacy. In situations where there are few alternative treatments, new tests are needed that can differentiate patients with DILI who would develop progressive liver injury if treatment is not stopped from patients who can safely continue drug therapy via "adaptation." Although there has been little progress in developing and validating such tests, new insights into the mechanisms underlying DILI suggest that the desired biomarkers probably exist and can be discovered through the application of new technologies for blood and possibly urine analyses. Such discovery efforts will require the establishment of well-annotated serum and urine banks from prospective clinical trials of drugs capable of causing progressive liver injury.