Methylprednisolone-related liver injury: A descriptive study using the French pharmacovigilance database - 11/10/20
, Sabrina Pierre a, Véronique Pizzoglio a, Corinne Simon b, Geneviève Durrieu c, Nathalie Bleyzac a, Aurore Gouraud a, Jérôme Dumortier dBienvenue sur EM-consulte, la référence des professionnels de santé.
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| pages | 12 |
| Iconographies | 1 |
| Vidéos | 0 |
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Résumé |
Key Points |
• | Intravenous methylprednisolone causality should be considered in case of acute liver injury. |
• | Liver injury was mainly hepatocellular. |
• | Data for oral methylprednisolone is insufficient to draw any conclusion. |
• | Systematic liver monitoring for high-dose intravenous methylprednisolone may be of value. |
Summary |
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.
Le texte complet de cet article est disponible en PDF.Keywords : Liver injury, Methylprednisolone, Pharmacovigilance, Safety
Plan
Vol 44 - N° 5
P. 662-673 - octobre 2020 Retour au numéro
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