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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
Summary
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- Troglitazone was withdrawn from the U.S. market due to severe liver injury.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.
- 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.