Rethinking Drug-Induced Liver Injury—A New Era of Pharmacovigilance

Accurately diagnosing drug-induced liver injury (DILI) is a persistent challenge due to the increasing number of drugs available in the market. The reported incidence of DILI fails to acknowledge the high mortality rates and healthcare costs associated with DILI-associated acute liver failure. Despite the availability of a reference for hepatotoxic risk, identifying the medications responsible for DILI remains difficult. In this study, the authors used pharmacoepidemiologic methods to analyze US Department of Veterans Affairs data and reevaluate the actual risk of DILI for nearly 200 potentially hepatotoxic medications. They identified 17 medications associated with high rates of hospitalization for severe acute liver injury, 11 of which were not classified as highly hepatotoxic based on existing case report data. Additionally, 7 medications classified as low risk in this study were categorized as high risk in the reference. These findings question current clinical practices in identifying culprit medications in DILI.