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Medical Science Monitor Basic Research


Hepatotoxicity Induced by Fluvastatin: A Reversible Acute Cholestatic Liver Injury

Unusual clinical course, Challenging differential diagnosis, Unusual or unexpected effect of treatment, Diagnostic / therapeutic accidents, Adverse events of drug therapy

Najah S. Alanazi, Tahani S. Alenazi, Khalidah A. Alenzi

Saudi Arabia Regional Drug Information & Pharmacovigilance Centre, Ministry of Health, Tabuk, Saudi Arabia

Am J Case Rep 2021; 22:e931418

DOI: 10.12659/AJCR.931418

Available online: 2021-07-01

Published: 2021-08-12

BACKGROUND: Fluvastatin, a commonly prescribed statin, is indicated for treatment of hypercholesterolemia in persons at high risk for coronary, cerebrovascular, and peripheral artery disease. However, there have been rare reports of liver injury or renal failure associated with use of fluvastatin.
CASE REPORT: We describe the case of a 69-year-old Saudi man with a medical history of diabetes mellitus and hypercholesterolemia for 2 years, on metformin, gliclazide modified release, daily aspirin, and simvastatin. Fluvastatin 40 mg daily was administered instead of simvastatin for 7 weeks before the patient was admitted to the hospital with fatigue, weakness, abdominal pain, loss of appetite, vomiting, itching, and elevated liver enzymes. Discontinuation of fluvastatin and other combined therapies led to a decrease in liver enzymes. He was diagnosed with fluvastatin-induced cholestatic liver injury and acute kidney disease.
CONCLUSIONS: The Naranjo scale indicates a probable relationship between cholestatic liver injury and fluvastatin, as well as a possible relationship between cholestatic injury and gliclazide and metformin. In our case report, we describe the synergistic effect of several factors in contributing to liver injuries, such as age, long-term gliclazide intake, and fluvastatin. Accordingly, we recommend close monitoring of patients’ liver and kidney function, especially in the elderly and those with polypharmacy, while allowing sufficient time for the liver function to recover from a reversible reaction to fluvastatin.

Keywords: Chemical and Drug Induced Liver Injury, Cholestasis, fluvastatin, Gliclazide, Metformin