A MULTI-CENTER, LONGITUDINAL STUDY OF DRUG- AND CAM-INDUCED LIVER INJURY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Liver injury due to prescription and non-prescription medication use is a medical, scientific, and public health problem of increasing frequency and importance in the United States. Drug-induced liver injury (DILI) is the most common reason for non-approval, withdrawal, limitation in use, and clinical monitoring by the Food and Drug Administration (FDA). Establishing a diagnosis of DILI is problematic due to the presence of other potential causes of liver injury, a lack of standardized, objective and reproducible diagnostic criteria, and the need for drug discontinuation and observation. Drug-induced liver injury (DILI) is defined as the development of an acute or chronic liver disease from a drug or chemical with associated laboratory, clinical and pathological features. There have been few prospective studies of DILI that have provided meaningful data on risk factors, characteristics profiles, and possible mechanisms of hepatotoxicity. The Drug-Induced Liver Injury Network (DILIN) is a NIH funded network that was established in 2003, and Indiana University School of Medicine is one of the clinical centers. One of the initiatives undertaken by the DILIN is the current protocol. In this multicenter, longitudinal study of drug and CAM-induced liver injury, we would like to prospectively enroll patients with DILI (and suitable controls) for conducting genetic and non-genetic research related to DILI.