Liver injury with drugs used for multiple sclerosis: A contemporary analysis of the FDA Adverse Event Reporting System

Multiple Sclerosis : Clinical and Laboratory Research
Ippazio Cosimo AntonazzoEmanuel Raschi

Abstract

Drug-induced liver injury (DILI) has been observed in patients with multiple sclerosis (MS), raising concerns on the liver safety of MS drugs. To describe DILI events with MS drugs by analyzing the FDA Adverse Event Reporting System. DILI reports were extracted and classified in overall liver injury (OLI), including asymptomatic elevation of liver enzymes, and severe liver injury (SLI). We performed disproportionality analysis by calculating adjusted reporting odds ratios (RORs) with 95% confidence interval (CI) and case-by-case evaluation for concomitant drugs with hepatotoxic potential. Fampridine showed statistically significant ROR for both OLI and SLI, whereas teriflunomide and fingolimod generated solid disproportionality (ROR > 2) only for OLI (ROR, 2.31; 95% CI, 2.12-2.52; and 2.53; 2.40-2.66, respectively). Among monoclonal antibodies, only alemtuzumab generated higher-than-expected ROR for OLI (1.34; 1.09-1.65). We also detected the expected hepatotoxic potential of beta interferon and mitoxantrone. Concomitant reporting of hepatotoxic drugs ranged from 26% (dimethyl fumarate) to 90% (mitoxantrone). These real-world pharmacovigilance findings suggest that DILI might be a common feature of MS drugs and call for (1) for...Continue Reading

References

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Citations

Mar 5, 2019·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Babak SoleimaniDavid Hunt
Aug 5, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Milo GattiEmanuel Raschi
Jun 15, 2019·Cells·Frances K NallyClaire E McCoy
Mar 2, 2021·Expert Opinion on Drug Safety·Ariane G S AraujoAstrid Wiens
Dec 18, 2020·ACS Medicinal Chemistry Letters·Michele RossiMaria Laura Bolognesi
Dec 24, 2021·Medicine·Cristiane Munaretto FerreiraVanessa Terezinha Gubert

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