Methylprednisolone-induced hepatotoxicity: experiences from global adverse drug reaction surveillance.

We identified a possible link between methylprednisolone and hepatotoxicity in VigiBase, the WHO global database of individual case safety reports (ICSRs), using a novel statistical method [1]. VigiBase is the world’s largest ICSR repository, containing 8.4 million reports as of October 2013. Methylprednisolone’s labelling information mentions transient increases in liver enzyme serum levels and hepatomegaly, but not clinically relevant hepatotoxicity [2]. However, a literature review of high-dose methylprednisolone by Gutkowski et al. identified 11 cases, including one Death .Our results urge for clinically manifest hepatotoxicity to be considered a probable adverse reaction of high-dose methylprednisolone. For low-dose methylprednisolone the evidence is not compelling. The typical clinical consequences of methylprednisolone-induced hepatotoxicity appear to be serious and reversible, but although no lethal case was found that clearly implicated methylprednisolone, severe liver damage is by definition potentially life-threatening. This emphasises the clinical importance of this adverse reaction.