Ketoconazole-induced hepatitis: a case with a definite cause-effect relationship.

Area of Science:

• Hepatology
• Clinical Pharmacology
• Drug-Induced Liver Injury (DILI)

Background:

• Ketoconazole is a widely used antifungal agent.
• Drug-induced liver injury (DILI) is a significant concern with many medications.
• Establishing causality for DILI can be challenging.

Observation:

• A female patient developed acute hepatitis after 180 days of ketoconazole (200 mg/day).
• Liver injury recurred upon unintentional re-exposure to ketoconazole six months later.
• Histological examination showed acute hepatitis with potential progression to chronicity.

Findings:

• A definitive causal link between ketoconazole and acute liver disease was established through rechallenge.
• The patient exhibited prominent accumulation of perisinusoidal lipocytes (Ito cells) on liver biopsy.
• Clinical and biochemical parameters indicative of hepatic injury were documented.

Implications:

• This case underscores the potential hepatotoxicity of ketoconazole.
• Physicians should monitor liver function in patients receiving long-term ketoconazole therapy.
• Further research into the mechanisms of ketoconazole-induced liver injury, including Ito cell involvement, is warranted.