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Session 8 - Risk Factors for Idiosyncratic DILI
Session Chair(s)
John R. Senior, MD
Associate Director for Science, Office of Surveillance and Epidemiology, CDER
FDA, United States
A great unknown challenge is how to identify the patient who is especially susceptible to drug-induced injury, or who may not be able to adapt to the drug after an initial mild injury and thenceforth be able to tolerate the drug, before giving the drug, or in time to stop it before irreversible damage occurs. Serious DILI is usually rare, but we have no biomarker, genetic test, or other way to know who will get it in advance. We rely on observation of the patient's response to the new (for them) drug . Whether early symptoms, such as nausea, fatigue, right upper abdominal discomfort, or some other symptom may come first, or whether slight elevations of serum transaminase activity(or gammaglutamyl transpeptidase, or other) activity comes first, we don't yet know. For now, either symptoms or serum enzyme elevations should be reported very promptly and rechecked within a few days to find out whether they are worsening or improving, and what can be learned by additional tests, questions, or other ways to diagnose the most likely or probable cause of the abnormalities. In this session, we shall explore the question of whether underlying liver diseases of various types (fatty liver-steatohepatitis, alcoholic liver disease, or viral hepatitis C, B or other) can be distinguished from drug-induced injury, i.e., acute-on-chronic injury, and if the diseases may either enhance or diminish drug-effects. These difficult distinctions will be discussed by master clinicians whose work it is to make such diagnoses in practice, or in evaluation of new drugs.
Speaker(s)
Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NAFLD/ NASH) and the Risk of Idiosyncratic DILI
Raj K. Vuppalanchi, MD
Indiana University School of Medicine, United States
Associate Professor of Medicine, Division of Gastroenterology
Alcohol/ Concomitant Drugs and the Risk of Idiosyncratic DILI
James W. Freston, MD, PhD
University of Connecticut Health Center, United States
Emeritus Professor of Medicine and Clinical Pharmacology
The Risk of Idiosyncratic DILI in Patients with Viral Hepatitis B and C
Kendall Marcus, MD
FDA, United States
Deputy Division Director Antiviral Products, CDER
Utility of Data Standards: Learning from Hepatitis C
Jeffry Florian, PhD
FDA, United States
Clinical Analyst, Division of Pharmacometrics, OND, CDER
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