Methylprednisolone‐Induced Liver Injury: Insights From FAERS Analysis and Comparison With DILIN Findings

We read with great interest the recent article by Ahmad et al. [1], which provides valuable insights into methylprednisolone-induced liver injury (MP-DILI) using data from the well-established Drug-Induced Liver Injury Network (DILIN). To further investigate this important drug safety issue and validate their findings, we conducted a comprehensive analysis of MP-related adverse events reported in the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q3 2024. Among the 21,635 MP-related adverse event reports identified, 218 cases of MP-DILI were reported. As illustrated in Figure 1, the characteristics of these cases closely align with the key findings from Ahmad et al. and other recent studies [2-4]. Females comprised the majority (69%) of MP-DILI cases (Panel A), and most patients (75%) were between 18 and 65 years old (Panel B). Notably, multiple sclerosis was the most common indication for MP use, accounting for 34% of all reported diagnoses (Panel C). The seriousness of MP-DILI was underscored by the fact that 91% of cases resulted in hospitalisation or other significant adverse events (Panel D). Interestingly, the mean time to onset of MP-DILI was 33.4 days, closely mirroring the 30-day latency reported by Ahmad et al. Furthermore, a survival curve analysis fitted by the Weibull distribution revealed that MP-DILI had a significantly different time to onset compared to other MP adverse events, with both being early-onset phenomena (Panel E). This finding suggests that close monitoring for liver injury is crucial in the first few weeks following MP administration. In conclusion, this comprehensive FAERS analysis strongly validates the key findings of Ahmad et al. and provides additional real-world evidence on the characteristics and impact of MP-DILI. These complementary insights underscore the importance of this drug safety issue and the need for heightened awareness, vigilant monitoring and proactive management strategies, especially in patients with multiple sclerosis receiving intravenous methylprednisolone. Further research is warranted to elucidate the underlying mechanisms and develop targeted approaches for the prevention and early detection of MP-DILI in clinical practice. Fangcai Yang: conceptualization, writing – original draft, and critical analysis of the original study. Wukun Ge: writing – review and editing, validation of scientific content, and contribution to the discussion of clinical implications. Shuangli Zhang: project administration, supervision, writing – review and editing, and correspondence with the journal. All authors read and approved the final version of the manuscript. The authors disclose no conflicts. This data can be accessed through the FDA's FAERS Public Dashboard at https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.