Rechallenge After Drug-Induced Liver Injury: A Debate of the Merits and Hazards From Industry, the US Food and Drug Administration, and Clinical Academia
Nov
10
2025
Convention Center: Room 143, Level 1
9:45 AM - 10:45 AM
World Class Speakers
Description
Hepatologists are often asked if a patient can restart a medication after an episode of DILI. Utilizing a friendly debate format, presenters highlight key points about the risk/benefit analysis in rechallenge and how to indentify patients suitable for a rechallenge trial. In addition, specific case scenarios with common medications are addressed. Given the nuances involved, the panel comprises stakeholders from academia, the pharmaceutical industry, and regulatory agencies to provide their perspective on the issue of rechallenge after DILI.Journey Maps
Presentations
9:45 AM - 9:55 AM
Nov
10
2025
Washington, D.C.
Rechallenge: A Regulatory Perspective on Pros and Cons
Mark Avigan, MD, CM, FAASLD, Presenter
Drug-Induced Liver Injury
10:05 AM - 10:15 AM
Nov
10
2025
Washington, D.C.
Rechallenge: Pros and Cons From a Scientific Causality Perspective
James H Lewis, MD, FAASLD, Presenter
Drug-Induced Liver Injury
Objectives
- Summarize the existing data regarding rechallenge after an episode of DILI.
- Review the considerations to be weighed in determining whether to give an alternative medication from the same drug class after DILI from the original medication.
- Describe the circumstances in which to consider rechallenge.