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Retrospective Study

A Study of Drug-Induded Liver Injury Due to Phenytoin, Isoniazid, Amoxicillin/Clavulanic Acid, and Valproic Acid

Background

Drug-induced liver injury (DILI) is the most common reason for regulatory actions concerning drugs in development and in clinical practice. Fortunately, severe DILI leading to jaundice is an infrequent event, with an annual incidence ranging from 1 in 10,000 to 1 in 1,000,000 prescription-years. The idiosyncratic nature of DILI plus its low incidence has hampered our ability to identify clinical, environmental, and genetic susceptibility factors. As a result, there is a great need to improve our detection, definition, and understanding of the mechanism of DILI.

To stimulate research, the NIDDK has established the Drug-Induced Liver Injury Network to conduct controlled, clinical studies into DILI.

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ILIAD's Research Goals

• Establish a database of patients with severe DILI due to 4 specific drugs.
• Establish a bank of biological specimens (serum, DNA, and immortalized lymphocytes) from DILI cases and controls.
• Maintain a registry of DILI cases with annual contact.

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How You can Help

We need your help with patient recruitment. If you have patients who are eligible, we want to hear from you.

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Eligibility Criteria

• Alive, with DILI onset on or after January 1, 1994.
• Age > 2 years old at enrollment.
• The implicated medication is: isoniazid (INH), pheny-toin (Dilantin), combination clavulanic acid/amoxicillin (Augmentin), or valproic acid (Depakote).
• Peak total serum bilirubin > 2.5 mg/dl or if valproic acid, INR > 1.5 / hospitalized.
• Detailed documentation of the event for causality as-sessment.

If you have a patient that meets the criteria contact the DILIN clinical site that is nearest to you.

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Study Protocol

• Screening criteria are reviewed during the initial contact with the subject.
• Clinical data are collected using a telephone or personal interview format.
• Detailed data are abstracted from medical records and charts.
• A blood sample is drawn and forwarded to a repository.

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