Drug-Induced Liver Toxicity

Drugs sometimes cause serious injuries to the livers of patients, with loss of hepatic function leading to illness, disability, hospitalization, and even life threatening liver failure and death or need for liver transplantation. As our aging world population uses more and more drugs, as well as self-prescribed over-the-counter medications, so-called “dietary supplements,” special diets, alcohol, and is exposed also to environmental chemicals, chances of such injury are rising. In the United States, drug-induced liver injury (DILI) is now the leading cause of acute liver failure (ALF), exceeding all other causes combined [see below: recent graphic data from WM Lee and colleagues from the Acute Liver Failure Study Group, updated to include data through 2007]:

This website is intended to present up-to-date presentations and discussions on issues pertinent to DILI, as well as some background information from previous conferences. The site is sponsored by the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), together with the American Association for the Study of Liver Diseases (AASLD), the Drug-Induced Liver Injury Network (DILIN) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Pharmaceutical Research and Manufacturers of America (PhRMA).

If you wish to use any of the material posted at this website, please request permission from any of the authors to do so, and please cite the source of the material giving credit to them.

Please send critique, comment, and suggestions for improvement of this website to John R. Senior, M.D. (john.senior@fda.hhs.gov) or Lana Pauls, M.P.H. (lana.pauls@fda.hhs.gov).

2008 Meeting

The 2008 meeting was held on March 26-27 at the National Labor College in Silver Spring, Maryland.

• 2008 Meeting agenda, presentations, and presentation abstracts
  • For references cited in abstracts, click on the PMID number (blue hyperlink) to see the PubMed abstract of the citation. If available under copyright law, you may obtain the full paper as a .pdf file by clicking the box at the upper right of the PubMed website.
• Guidance for Industry (Draft): Drug-Induced Liver Injury: Premarketing Clinical Evaluation (posted 25 October 2007)
  • Comments received by 24 December 2007 for Docket No. 2007D-0396
  • Federal Register notice of Reopening of Comment Period; (announced March 6, 2008)
    Public conference was held on March 26 and 27, 2008. Additional written comments about the draft guidance or the conference will be accepted up to 30 June, 2008 for Docket No. FDA-2008-D-0128.  [PDF]

Previous Meetings

• AASLD-FDA-NIH-PhRMA- Hepatotoxicity Special Interest Group Conference, 2007
• AASLD-FDA-NIH-PhRMA- Hepatotoxicity Steering Group Meeting, 2006
• FDA-PhRMA-AASLD Hepatotoxicity Steering Committee Meeting, 2005
• Hepatotoxicity Steering Group Meeting, 2004
• Hepatocoxicity Steering Group Meeting, 2003
• Drug-Induced Liver Injury: A National and Global Problem, 2001
• CDER Staff College Course: Drugs and the liver: What they do to each other. April 19-20, 1999. Course agenda

Report serious adverse events to FDA's MedWatch at 1-800-FDA-1088; or
http://www.fda.gov/medwatch/how.htm
 

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Date created:  August 3, 2005, updated June 4, 2008

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