THE European Medicines Agency has finalised a review of multiple sclerosis medicine Zinbryta (daclizumab beta), confirming findings that risks associated with the drug outweigh its benefits.
The agency's Pharmacovigilance Risk Assessment Committee (PRAC) has also confirmed a recommendation to suspend hydroxyethyl-starch (HES) solutions for infusion across the EU, because they continued to be used in critically ill patients despite restrictions introduced in 2013 to reduce the risk of kidney injury.
The PRAC has recommended new measures to minimise the risk of rare but serious liver injury with Esmya for uterine fibroids, concluding the medicine must not be used in women with liver problems and that regular liver tests are required for other patients.
The EMA said it was also evaluating preliminary results from a study which found four cases of birth defects such as spina bifida in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.
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