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Pemoline‐associated fulminant liver failure: Testing the evidence for causation
Author(s) -
Berkovitch Matitiahu,
Pope Elena,
Phillips James,
Koren Gideon
Publication year - 1995
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/0009-9236(95)90233-3
Subject(s) - methylphenidate , fulminant hepatic failure , fulminant , medicine , pediatrics , liver transplantation , attention deficit hyperactivity disorder , psychiatry , transplantation
Background Pemoline is a central nervous system stimulant used in treating children with attention deficit‐hyperactivity disorder. Hepatotoxicity has been commonly reported in association with pemoline; however, only two reports of cases of fatal liver failure have been published. Objectives We report on a 14‐year‐old boy who received concomitant pemoline and methylphenidate in whom fulminant liver failure occurred and for whom liver transplantation failed. Other causes of fulminant liver failure were ruled out, and the liver biopsy was suggestive of drug toxicity. We estimated the probability that these three cases represent an increased risk of fulminant liver failure associated with pemoline. Results Based on the three known cases of fatal liver failure associated with pemoline use, we calculated that a child receiving pemoline has a relative risk of development of fulminant liver failure of 45.3 (95% confidence interval, 4.1 to 510). This highly significant association ( p < 0.001) suggests causation. Conclusions Because pemoline has been widely used in recent years, further studies are needed to better quantify this risk in children with attention deficit‐hyperactivity disorder. Clinical Pharmacology & Therapeutics (1995) 57 , 696–698; doi: