Fulminant drug-induced hepatic failure leading to death or liver transplantation in Sweden

Scand J Gastroenterol. 2005 Sep;40(9):1095-101. doi: 10.1080/00365520510023846.


Objective: There are only a few data on the prevalence of drug-induced liver injury associated with fatal outcome. The aim of this study was to determine the nature and number of suspected adverse drug-induced liver disease associated with fatalities and/or liver transplantation since reporting of adverse drug reactions (ADRs) started in Sweden.

Material and methods: All reports of suspected hepatic ADRs with fatal outcome received by the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) from 1966 to 2002 were reviewed and causality assessed.

Results: The SADRAC received 151 reports of suspected ADRs with fatal outcome from liver injury; 48 cases were either unlikely or excluded. Of the remaining 103 cases, 13 (13%) were highly probable, 48 (47%) probable and 42 (41%) possible. The median age of the 103 patients was 64 years (47-77 interquartile range (IQR)) and 59 (57%) were males. The majority of cases were classified as hepatocellular (75%), with only 15% cholestatic and 10% mixed. Halothane, paracetamol, flucloxacillin, sulfamethoxazole/trimethoprim and diclofenac were the most common drugs associated with fatal outcome. Seventeen patients underwent liver transplantation, most commonly because of paracetamol and disulfiram toxicity.

Conclusions: A wide range of suspected ADRs are associated with fatalities. Antibiotics and analgesics are associated with the greatest number of reports of deaths.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetaminophen / adverse effects
  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data
  • Aged
  • Aged, 80 and over
  • Analgesics, Non-Narcotic / adverse effects
  • Anesthetics, Inhalation / adverse effects
  • Anti-Infective Agents / adverse effects
  • Child
  • Diclofenac / adverse effects
  • Female
  • Floxacillin / adverse effects
  • Halothane / adverse effects
  • Humans
  • Liver Failure, Acute / chemically induced*
  • Liver Failure, Acute / mortality*
  • Liver Failure, Acute / surgery
  • Liver Transplantation / statistics & numerical data*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Sulfamethoxazole / adverse effects
  • Survival Rate
  • Sweden / epidemiology


  • Analgesics, Non-Narcotic
  • Anesthetics, Inhalation
  • Anti-Infective Agents
  • Diclofenac
  • Acetaminophen
  • Floxacillin
  • Sulfamethoxazole
  • Halothane