Posted by Michael Wonder on 11 Jul 2017
EMA seeks views of public during its safety review of valproate
11 July 2017 - Registration opens for first public hearing
The EMA is inviting citizens to share their experience with valproate – a medicine that treats epilepsy, bipolar disorder and migraine – at its very first public hearing on 26 September 2017 at the Agency’s offices in London.
The public hearing is part of a review by EMA’s Pharmacovigilance Risk Assessment Committee that looks at the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age. There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that EU-wide risk minimisation measures currently in place do not seem to be sufficiently effective.
