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 2014].

The title of the slide is Etiology (cause) of Acute Liver Failure in U.S. adults, dated January 2015 to reflect data gather from 1998-2014 by the Acute Liver Failure Study Group. The slide shows a series of 11 vertical red bars indicating the number of cases for each cause of acute liver failure about which the Study Group had received reports in the past 17 years, totaling 2224. The bars range in height corresponding to numbers from 15 to 1025, the first two bars on the left representing 1025 cases caused by overdoses of acetaminophen (commonly called Tylenol in the U.S, or paracetamol in England), 46% of the total, and 238 caused by prescription drugs, 11% of the total. The next eight smaller bars represent cases of liver failure caused by various liver diseases such as viral hepatitis B or A, impaired blood flow to liver, autoimmune reactions, and rare other problems ranging from 15 to 159 cases and totaling 687 cases, 31%, or much less than the 1263 caused by drugs, 57%. The last column on the right is for 274 cases, 12% of the total, where the cause could not be determined from the reported information available.

This website presents 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 disclaimer icon (AASLD), the Drug-Induced Liver Injury Network disclaimer icon (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).

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