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Updated: Jul 23, 2026
08:18
A Model of Chronic Nutrient Infusion in the Rat
Published on: August 14, 2013
Troglitazone (Rezulin) and hepatic injury
1Pharmaceutical Assessments, Inc., 104 Foxhall Lane, Narberth, PA 19072, USA. gfaich@yahoo.com
Pharmacoepidemiology and Drug Safety
|February 7, 2002
Summary
Severe liver disease reports linked to troglitazone decreased over time. This decline in oral hypoglycemic agent hepatotoxicity may be due to enhanced monitoring and publicity.
Area of Science:
- Pharmacovigilance
- Hepatology
- Clinical Pharmacology
Background:
- Troglitazone, an oral hypoglycemic agent, was associated with severe liver injury.
- Understanding the trends in reported liver disease is crucial for patient safety.
Purpose of the Study:
- To analyze US rates of severe liver disease reported for troglitazone (March 1997-February 2000).
- To assess the impact of publicity on troglitazone hepatotoxicity reporting.
Main Methods:
- Utilized FDA and Parke-Davis reports of liver failure, jaundice, or hyperbilirubinemia.
- Calculated incidence rates based on patient and person-time exposure estimates.
- Quantified media and medical literature publicity regarding troglitazone hepatotoxicity.
Main Results:
- 83 cases of liver failure were reported; 59% were possibly or probably linked to troglitazone.
- Reported hepatic failure rates per 100,000 person-years decreased from 8.3 to 2.7 over three years.
- Publicity included 470 lay press and 158 medical literature articles on hepatotoxicity.
Conclusions:
- Reported severe liver disease rates declined significantly during troglitazone's marketing.
- This decline may be attributed to stricter monitoring and improved patient selection due to publicized hepatotoxicity risks.
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