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, and limitation in use by the Food and Drug Administration (FDA). The goal of this multi-center study is to develop an improved means of detecting, defining, and studying DILI in the United States. Subjects who have taken a drug, an over-the-counter (non-prescription) medicine, or an herbal remedy (known collectively as complementary or alternative medicines- CAM) and either did or did not develop a liver reaction while taking the drug in question are potential candidates for participation. Patients enrolled that did suffer a liver reaction are known as cases, and those that did not suffer a liver reaction are known as controls. Participation for both case and control subjects will begin with a baseline visit. This visit will include a medical history and interview and completion of demographic, pharmacy history, alcohol and tobacco use, symptoms, and quality of life questionnaires. Blood and urine samples will be collected for future research studies including genetic testing. A minority of case patients may need to undergo a liver biopsy or liver ultrasound to clarify the diagnosis or severity of liver disease. All case subjects will return for a 6 month follow-up visit wherein a medical interview, questionnaires, and blood and urine samples will be collected as well as a liver ultrasound. Case subjects with evidence of ongoing liver injury at 6 months will be asked to return at 12 months and yearly thereafter for a follow-up medical interview, questionnaires, and urine and blood sample collections. A liver biopsy may be recommended for case subjects with evidence of persistent liver injury at 12 months. Yearly contacts will be made to both case and control subjects to update contact information and to possibly invite subjects to take part in future research studies.
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