Judith Cottin1, Sabrina Pierre2, Véronique Pizzoglio2, Corinne Simon3, Geneviève Durrieu4, Nathalie Bleyzac2, Aurore Gouraud2, Jérôme Dumortier5. 1. Service Hospitalo-Universitaire de Pharmacotoxicologie, Centre de Pharmacovigilance, Hospices Civils de Lyon, CHU-Lyon, 69003 Lyon, France. Electronic address: judith.cottin@chu-lyon.fr. 2. Service Hospitalo-Universitaire de Pharmacotoxicologie, Centre de Pharmacovigilance, Hospices Civils de Lyon, CHU-Lyon, 69003 Lyon, France. 3. Service de Pharmacosurveillance, Centre Régional de Pharmacovigilance, CHRU Tours, 37044 Tours, France. 4. Service de Pharmacologie Médicale et Clinique, Centre Régional de PharmacoVigilance, de Pharmaco-épidémiologie et d'Informations sur le Médicament, INSERM U 1027, Faculté de Médecine, Centre Hospitalier Universitaire, 31000 Toulouse, France. 5. Service d'Hépato-gastro-entérologie, Hôpital Edouard-Herriot, Hospices Civils de Lyon, 69003 Lyon, France.
Abstract
PURPOSE: Hepatotoxicity associated with methylprednisolone (MP) is rarely reported in the literature. The aim of the present study was to review the characteristics of acute liver injury associated with intravenous (IV) or oral MP registered in the French pharmacovigilance database (FPD). METHODS: All cases with MP coded as suspected, concomitant, or interacting drug associated with liver injury as the adverse effect reported up to May 2016 were extracted from the FPD. Cases were identified using the "Drug related hepatic disorders" Standard Medical Query. RESULTS: A total of 97 cases of liver injury associated with MP were analysed; 58.8% were women and the median age was 46 years (range: 1-91). MP was used for an autoimmune disease in 47.6% of cases including 26 cases of multiple sclerosis, and was IV in 79.4% of cases. Nearly three-quarters of patients (73,2%) had a hepatocellular type of injury, the severity of which was mainly mild (45%) or moderate (31%). Most patients (92%) spontaneously and fully recovered within a mean 38.4 days. A rechallenge using the IV route was performed in 13 patients and for 10 (76.9%) this was positive (the initial type of injury was hepatocellular for all these cases). Regarding IV route of administration (n=77), MP was coded as the only suspected drug in 22% of cases. DISCUSSION: The results suggest that IV MP causality should be considered in case of acute liver injury while data for oral MP is insufficient; systematic liver monitoring for high-dose IV MP may be recommended.
PURPOSE:Hepatotoxicity associated with methylprednisolone (MP) is rarely reported in the literature. The aim of the present study was to review the characteristics of acute liver injury associated with intravenous (IV) or oral MP registered in the French pharmacovigilance database (FPD). METHODS: All cases with MP coded as suspected, concomitant, or interacting drug associated with liver injury as the adverse effect reported up to May 2016 were extracted from the FPD. Cases were identified using the "Drug related hepatic disorders" Standard Medical Query. RESULTS: A total of 97 cases of liver injury associated with MP were analysed; 58.8% were women and the median age was 46 years (range: 1-91). MP was used for an autoimmune disease in 47.6% of cases including 26 cases of multiple sclerosis, and was IV in 79.4% of cases. Nearly three-quarters of patients (73,2%) had a hepatocellular type of injury, the severity of which was mainly mild (45%) or moderate (31%). Most patients (92%) spontaneously and fully recovered within a mean 38.4 days. A rechallenge using the IV route was performed in 13 patients and for 10 (76.9%) this was positive (the initial type of injury was hepatocellular for all these cases). Regarding IV route of administration (n=77), MP was coded as the only suspected drug in 22% of cases. DISCUSSION: The results suggest that IV MP causality should be considered in case of acute liver injury while data for oral MP is insufficient; systematic liver monitoring for high-dose IV MP may be recommended.