Purpose
To establish a nationwide registry of people who have experienced liver injury within the past 6 months after using certain drugs or herbal medicines (also called Herbal and Dietary Supplements, or HDSs). We want to understand why some people have unwanted liver reactions after taking certain drugs or HDSs and why other people do not.
Voluntary Participation
Your participation is voluntary and will cost you nothing. You will receive a nominal fee to cover any expenses associated with the study and to compensate you for your effort. You may drop out of the study at any time.
Benefits
You may not receive any direct benefit from this study, but you are contributing in an important way to medical research that may benefit others in the future. If we can discover why people have unwanted reactions to drugs, we may be able to design safer drugs in the future.
How the Study Will Proceed
- A member of the study team will review 2 forms with you in person: a consent and a release of medical information. You will have the opportunity to ask any questions you may have about the study. If you are still interested in participating, you will be asked to sign the forms.
- You will then receive a physical exam, answer questions about your medical history, and complete questionnaires about your quality of life and current symptoms. You will be asked for the following information:
- Date you started taking the medication that may have caused a liver problem
- Other drugs and herbal medicines you were taking and when
- Your medical history
- Any family history of liver problems
- History about your smoking and alcohol use
- Your blood will be drawn for genetics research studies and a urine sample will be collected.
- Some case subjects will be asked to have a liver ultrasound performed. If one has been performed in the past, they will be asked to agree to release the results to the study team.
- You will be contacted (usually by mail) each year for several years and asked to update your contact information. This follow-up is important to learn about the long-term effects of the liver reaction and for possible enrollment into future studies.
Remember: You may withdraw from the study at any time and request that your blood sample be destroyed.