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Published on: May 29, 2020
Etifoxine-induced acute hepatitis: a case series
Céline Moch1, Fanny Rocher, Pascale Lainé
1Pharmacovigilance centre of Lyon, Lyon, France.
Summary
Etifoxine can cause acute liver injury, including severe hepatitis, in patients treated for anxiety. Prompt withdrawal of etifoxine led to recovery in most cases, highlighting a critical safety concern.
Area of Science:
- Hepatology
- Pharmacovigilance
- Clinical Toxicology
Background:
- Etifoxine is prescribed for anxiety-related psychosomatic symptoms.
- Recent reports indicate a potential link between etifoxine use and acute hepatitis.
- French pharmacovigilance centers have noted an increase in such cases.
Purpose of the Study:
- To investigate cases of etifoxine-induced liver injury.
- To analyze the characteristics and outcomes of etifoxine hepatitis.
- To assess the safety profile of etifoxine regarding hepatotoxicity.
Main Methods:
- Retrieved cases of liver disorders associated with etifoxine from the French pharmacovigilance database (since Nov 1995).
- Included cases with clear temporal association, no alternative causes, and sufficient data.
- Analyzed clinical presentation, laboratory findings, and patient outcomes.
Main Results:
- Eighteen cases of etifoxine-associated hepatitis were analyzed.
- Hepatitis onset occurred after a median of 18 days of treatment.
- Most cases involved cytolytic or mixed-type hepatitis; one required liver transplantation, but 15 patients recovered after drug withdrawal.
Conclusions:
- Etifoxine is confirmed to be a potential cause of acute liver injury.
- The severity of etifoxine-induced hepatitis can be significant, including fulminant cases.
- This serious adverse effect is not currently listed in the product's summary of characteristics.
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