Drug-Induced Liver Injury Network (DILIN)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Drug-Induced Liver Injury Network (DILIN) to collect and analyze cases of severe liver injury caused by prescription drugs, over-the-counter drugs, and alternative medicines, such as herbal products and supplements.]]>
Inclusion Criteria: Age > 2 years at enrollment into the study. Evidence of liver injury that is known or suspected to be related to consumption of a drug or CAM product in the 6-month period prior to enrollment. Written Informed consent from the patient or the patient's legal guardian. Documented clinically important DILI, defined as any of the following: ALT or AST > 5 x ULN or A P'ase > 2 x ULN observed on at least 2 consecutive blood draws in patients with previously normal values. If baseline (BL) ALT, AST or A P'ase are known to be elevated, then ALT or AST > 5 x BL or A P'ase > 2 x BL on at least 2 consecutive blood draws. "Baseline" is defined as the average of at least 2 measurements performed during the 12-month period prior to starting the DILI medication. Any elevation of ALT, A P'ase, or AST, associated with (a) increased total bilirubin [≥ 2.5 mg/dL], in the absence of prior diagnosis of liver disease, Gilbert's syndrome, or evidence of hemolysis or (b) coagulopathy with INR > 1.5 in absence of coumadin therapy or known vitamin K deficiency. Exclusion Criteria: Patients with any of the following will not be eligible for participation: Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be the primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy, or radiology. Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease which may confound the ability to make a diagnosis of DILI. Acetaminophen hepatotoxicity Liver transplant or allogeneic bone marrow transplant prior to the development of drug- or CAM-induced liver injury. ]]>
The DILIN network has been active since 2003 and has enrolled over 2,000 patients with drug-induced liver injury.]]>