The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its very first public hearing on 26 September 2017 to review the use of using valproate-containing medicines in women and girls who are pregnant or of childbearing age.
As it is a public meeting, EU citizens will be able to share their experiences of these medicines, which are approved nationally in the EU to treat epilepsy, bipolar disorder and in some countries, migraines.
Further information, including a list of specific questions on which information from the public is sought, a summary of the safety concerns, as well as practical information on how to participate and an application form will be published at the beginning of July.
There are serious risks including birth abnormalities with the use of valproate-containing medicines. In 2013, the US Food and Drug Administration contraindicated a number of medicines in this class in pregnant women for the prevention of migraine headaches.
The decision to hold the meeting follows the adoption of new rules that will give EU citizens a voice in the evaluation of the safety of medicines.
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