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Retrospective Study

Idiosyncratic Liver Injury Associated with Drugs

Purpose | Liver Injury | Participate | Privacy | Requirements | Benefits | Procedures | Download Brochure PDF

Purpose

The purpose of this study is to establish a nationwide registry of people who have experienced idiosyncratic (unusual) liver injury due to taking certain prescribed medications. The four medications are isoniazid (INH), phenytoin (Dilantin), combination clavulanic acid/amoxicillin (Augmentin), or valproic acid (Depakote). It is a nonprofit study sponsored by the National Institute of Diabetes & Digestive & Kidney Diseases, U.S. National Institutes of Health (NIH).

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Liver Injury due to Drugs—A Serious Concern

Liver injury due to drugs is the main reason drugs do not get approved by the U.S. Food and Drug Administration or get removed from the market after initial approval. Through the participation of you and others like you, we hope to be able to discover why people have unwanted liver reactions to certain drugs. Being able to study people who have had such reactions is the only way we are able to identify the reasons for these reactions.

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Voluntary Participation

Your participation is entirely voluntary and will not cost you anything. You will receive a nominal fee to cover any expenses associated with the study and to compensate you for your effort.

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Privacy Protection

Your identity will be kept confidential; your name will not be on the blood sample you give, and any results of the blood sample will not go into your medical records. Your records will be kept confidential; the only people who may review them are representatives of the NIH, the institutional review board, and the data coordinating center at the Duke Clinical Research Institute.

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What will be Required of You

If you decide to take part in this study, you will be asked to give us permission to look at your medical records and take a small sample of blood. You will also be given the option to be followed up, by someone on the study team contacting you (usually by phone) once a year, for up to 20 years. You may drop out of the study at any time. You might also be offered opportunities to take part in other studies, but this would be completely up to you.

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Benefits to You and Others

You may receive no direct benefit from this study, except for the satisfaction of knowing that you have contributed in an important way to medical research that may benefit others in the future. If we are able to discover why people have unwanted reactions to drugs, we may be able to test people before giving them medications and prevent these reactions. It may also make it possible to design safer drugs in the future, which would benefit everyone.

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The Study Will Proceed as Follows:

1. Please review the enclosed consent forms and the release-of-medical-information form. Someone connected with the study will call to go over the documents with you and answer any questions you may have.
2. The study contact person will also schedule a time(s) to complete a questionnaire (which can be done over the telephone) and to collect a blood sample. Both may be able to be completed at the same visit. For the questionnaire, you will need the following information:
   • Month and year when you started taking the medication, and month and year when you started having the liver problems
   • Other drugs and herbal preparations you were taking around this time
   • Names of all the doctors who were helping you during this time
   • Any related information about the members of your family
3. Then you will be asked to sign the consent and release-of-medical-information forms and provide them to the DILIN study team.
4. Once you have given the blood sample, your participation has ended for the first year. Thereafter, someone from the study team will try to get in touch with you annually just to keep your contact information up to date.

Remember that you may withdraw from the study at any time and request that your blood sample be destroyed.

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