cqvip:Background/Aims:Limited systematic data exists on the incidence of drug-induced hepatotoxicity due to disulfiram and the most important prognostic markers.We aimed to determine the nature and frequency of suspected disulfiram hepatotoxicity in Sweden.Methods:All reports of suspected hepatic adverse drug reactions(ADR)associated with disulfiram received by the Swedish Adverse Drug Reactions Advisory Committee(SADRAC)1966-2002 were reviewed.Causality assessment was based on the International Consensus Criteria.Results:A total of 82 reports of disulfiram suspected ADRs had at least a possible causal relationship.Eight patients died or underwent liver transplantation(Tx).Mortality or Tx was 16%in patients with jaundice.The median age of the patients(65%males)was 45 years with a median duration of treatment of 42 days.Bilirubin was higher(P < 0.0001)in the deceased/transplanted patients compared to surviving patients.No difference was observed in age or duration of therapy between deceased and transplanted and those who recovered.Eosinophilic infiltration in liver biopsies was associated with a favourable outcome,hepatocyte drop-out with a poor outcome.Conclusions:Disulfiram associated hepatitis has a considerable mortality risk.Histological signs of immunoallergy seem to be common.Bilirubin and hepatocyte drop-out were the only predictors for death or transplantation.
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