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Related Experiment Videos

Troglitazone-induced liver failure: a case study.

David J Graham1, Lanh Green, John R Senior

  • 1Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, HFD-400, Room 15B-32, Rockville, MD 20857, USA. grahamd@cder.fda.gov

The American Journal of Medicine
|April 12, 2003
PubMed
Summary
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Troglitazone use increased liver failure risk, with most cases progressing rapidly. Continued drug use elevated hepatic failure risk, suggesting monthly monitoring may be ineffective.

Area of Science:

  • Hepatology
  • Clinical Pharmacology
  • Drug Safety

Background:

  • Troglitazone was withdrawn from the U.S. market due to severe liver injury.
  • This study investigates the clinical characteristics and risk of liver failure associated with troglitazone.

Observation:

  • 94 cases of liver failure (89 acute, 5 chronic) were reported to the FDA.
  • Acute liver injury often occurred rapidly, within one month, and recovery without transplantation was rare.
  • The incidence of liver failure remained elevated for at least 26 months of troglitazone use.

Findings:

  • The number needed to harm was estimated to be between 600 to 1500 patients at 26 months.
  • Rapid progression to irreversible liver injury occurred in a significant proportion of patients.

Related Experiment Videos

  • The cumulative risk of hepatic failure increased with continued troglitazone exposure.

    • Implications:

    • Monthly monitoring of liver enzymes may not effectively prevent troglitazone-induced acute liver failure.
    • The findings raise concerns about the safety profile of troglitazone and similar drugs.
    • Understanding the time course of liver injury is crucial for managing drug-induced hepatotoxicity.