Posted by Michael Wonder on 29 Oct 2017
PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage
27 October 2017 - Zinbryta to be used only in a restricted patient group, with strict liver monitoring
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver.
The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
