Predicting the outcome of drug-induced liver disease

Drug-induced liver disease (DILD), a potential complication seen with some medications, is usually not life-threatening, but may occasionally be more severe with a high mortality, requiring a liver transplant in selected cases. During the last decade, drug-induced liver injury has led to the withdrawal of a number of drugs from the market. Hy's rule, an observation by the late Dr. Hyman Zimmerman, states that the combination of high liver cell damage as measured by liver enzymes and jaundice induced by a drug is associated with a fatality rate of 10-50 percent. This rule has been advocated by the FDA for assessing the liver toxicity of newly developed drugs, but it has never been scientifically validated.

A study by Einar Bjrnsson, M.D., Ph.D. and Rolf Olsson, M.D., Ph.D. of the department of internal medicine at Sahlgrenska University Hospital in Gothenburg, Sweden and published in the August 2005 issue of Hepatology, analyzed reports of suspected drug-induced liver injury received by the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) in order to evaluate the validity of Hy's rule and determine what factors might predict the outcome of different forms of DILD.

Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD), published by John Wiley & Sons, Inc. is available online via Wiley InterScience at http://www.interscience.wiley.com/journal/hepatology.

A total of 784 reports were included in the analysis, each with bilirubin greater than twice upper normal limits and ALT (a liver enzyme that when elevated indicates liver damage) greater than three times upper normal limits. Of these, 409 cases had hepatocellular or HC liver injury (damage to liver cells); while 206 had cholestatic (bile flow) injury and 169 had mixed liver injury. In 633 cases, one drug was suspected of causing the liver injury, while in 151 cases more t

Contact: Amy Molnar
John Wiley & Sons, Inc.

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