PEMOLINE-ASSOCIATED FULMINANT LIVER-FAILURE - TESTING THE EVIDENCE FOR CAUSATION

Background: Pemoline is a central nervous system stimulant used in tre ating children with attention deficit-hyperactivity disorder. Hepatoto xicity has been commonly reported in association with pemoline; howeve r, only two reports of cases of fatal liver failure have been publishe d. 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 d rug toxicity. We estimated the probability that these three cases repr esent an increased risk of fulminant liver failure associated with pem oline. Results: Based on the three known cases of fatal liver failure associated with pemoline use, we calculated that a child receiving pem oline has a relative risk of development of fulminant liver failure of 45.3 (95% confidence interval, 4.1 to 510). This highly significant a ssociation (p < 0.001) suggests causation. Conclusions: Because pemoli ne has been widely used in recent years, further studies are needed to better quantify this risk in children with attention deficit-hyperact ivity disorder.