OBJECTIVE: Etifoxine is approved for the treatment of psychosomatic manifestations of anxiety. Several cases of acute hepatitis have been recently notified to the French pharmacovigilance centres. Our aim was to review all relevant cases of etifoxine hepatitis. METHODS: All cases of liver disorders involving etifoxine and reported since November 1995 were extracted from the French pharmacovigilance database. Only cases with suggestive chronological events, no other drug-related or non-drug causes, and sufficient information, were included. RESULTS: Of the 30 selected cases, 18 were retained for further analysis. The median duration of treatment before the onset of symptoms was 18 days (11 to 61 days). The results of liver tests evidenced cytolytic hepatitis in 15 cases and mixed-type hepatitis in 3. One patient also exposed to lisinopril/hydrochlorothiazide developed a fulminant hepatitis that required liver transplantation and six other patients had biological signs of severity. Except for the transplanted patient, 15 patients fully recovered within 3 months, and two clearly improved (further outcome unknown) after etifoxine withdrawal. CONCLUSION: One previously published case and our series confirm that etifoxine can cause acute liver injury with a possibly severe outcome. This adverse effect is not mentioned in the summary of the product characteristics.
OBJECTIVE:Etifoxine is approved for the treatment of psychosomatic manifestations of anxiety. Several cases of acute hepatitis have been recently notified to the French pharmacovigilance centres. Our aim was to review all relevant cases of etifoxinehepatitis. METHODS: All cases of liver disorders involving etifoxine and reported since November 1995 were extracted from the French pharmacovigilance database. Only cases with suggestive chronological events, no other drug-related or non-drug causes, and sufficient information, were included. RESULTS: Of the 30 selected cases, 18 were retained for further analysis. The median duration of treatment before the onset of symptoms was 18 days (11 to 61 days). The results of liver tests evidenced cytolytic hepatitis in 15 cases and mixed-type hepatitis in 3. One patient also exposed to lisinopril/hydrochlorothiazide developed a fulminant hepatitis that required liver transplantation and six other patients had biological signs of severity. Except for the transplanted patient, 15 patients fully recovered within 3 months, and two clearly improved (further outcome unknown) after etifoxine withdrawal. CONCLUSION: One previously published case and our series confirm that etifoxine can cause acute liver injury with a possibly severe outcome. This adverse effect is not mentioned in the summary of the product characteristics.