Clinical-liver, pancreas, and biliary tractDrug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period
Section snippets
Materials and Methods
The study population was all cases of toxic liver disease assembled in the Regional Registry of Hepatotoxicity in southern Spain since its foundation in April 1994. The registry is coordinated by 2 of the authors (R.J.A. and M.I.L.). The operational structure of the registry, data recording, and case ascertainment have been summarily reported elsewhere.6 In addition, several of the cases reported here have been published in peer-reviewed journals as case reports or case series.6, 7, 8
The
Demographic and Clinical Characteristics
From April 1994 to August 2004, 570 cases were submitted by 32 participant clinical units to the coordinating center belonging to 9 autonomous regions. One hundred nine were excluded: 36 because of unreliable chronologic criteria, 59 because an alternative cause of injury could be identified, including choledocholithiasis (13), viral hepatitis (11), underlying malignancy (10), autoimmune hepatitis (6), ischemic hepatitis (6), nonalcoholic steatohepatitis (4), alcoholic hepatitis (3), systemic
Discussion
Drug-induced idiosyncratic hepatotoxicity remains a challenge of modern hepatology. Hepatotoxicity is typically detected after marketing when several thousand patients are exposed to the drug, and regulatory authorities are often compelled to make decisions based on scanty, fragmentary, and incomplete epidemiologic data.15 In addition, whereas a major challenge is to be able to identify predisposed subjects before they receive the drug, genetic and environmental factors that appear to operate
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Supported in part by a research grant from the Agencia Española del Medicamento.