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   DIR Return to: COPAXONE, GLATOPA (glatiramer acetate)
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       #Post#: 4708--------------------------------------------------
       Real-world pharmacovigilance study of drug-induced autoimmune
       hepatitis from FAERS database
   DIR By: agate
       Date: February 9, 2025, 3:21 pm
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       From Nature (February 8, 2025)--"Real-world pharmacovigilance
       study of drug-induced autoimmune hepatitis from the FAERS
       database":
  HTML https://www.nature.com/articles/s41598-025-89272-x
       This part concerns glatiramer acetate:
       --- Quote ---
       > Glatiramer acetate, commonly used for multiple sclerosis due
       to its favorable safety profile, has been implicated in over 50
       reported cases of liver injury in the FAERS [FDA Adverse Event
       Reporting System] database. Among these, 3 cases involved
       classic AIH requiring prolonged immunosuppressive therapy, and 5
       cases presented with transient elevations in antinuclear
       antibodies or smooth muscle antibodies, indicative of
       immune-mediated liver injury. The exact mechanism remains
       unclear, but potential pathways include Th2 cell induction or
       mitochondrial damage.  Routine liver function monitoring is
       recommended during the initial 6 months of treatment,
       particularly for elderly patients, those with chronic liver
       disease, or those with a history of DILI [drug-induced liver
       injury].
       --- End Quote ---
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