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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 he
patitis from FAERS database
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][font=-apple-system]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[/font][font=-apple-system], and 5
cases presented with transient elevations in antinuclear
antibodies or smooth muscle antibodies, indicative of
immune-mediated liver injury[/font][font=-apple-system]. The
exact mechanism remains unclear, but potential pathways include
Th2 cell induction or mitochondrial
damage[/font][font=-apple-system].[/font] [font=-apple-system]
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].[/font][/quote]
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