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

Abstract

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.

• Authors: Einar Björnsson, Pernilla Jerlstad, Annika Bergqvist, Rolf Olsson
• Journal: Scandinavian journal of gastroenterology (Scand J Gastroenterol) Vol. 40 Issue 9 Pg. 1095-101 (Sep 2005) ISSN: 0036-5521 [Print] England
• PMID: 16165719 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• 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, mortality, surgery)
• Liver Transplantation (statistics & numerical data)
• Male
• Middle Aged
• Retrospective Studies
• Sulfamethoxazole (adverse effects)
• Survival Rate
• Sweden (epidemiology)