The European Medicines Agency (EMA) is to hold a public hearing as part of its safety review on the use of valproate-containing medicines in women who are pregnant or of childbearing age. This is the first time a public hearing has been held during an EMA safety review.
In 2014, the EMA recommended measures to strengthen warnings and restrictions on the use of valproate medicines in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb. Some EU member states have since carried out additional assessments of the impact of the measures at national level and concerns have been raised about how effective the measures have been in increasing awareness and reducing valproate use appropriately in its various indications. The French medicines regulator, ANSM, requested the EMA review the effectiveness of the measures and consider whether further EU-wide action is warranted.
The public hearing will take place on 26 September 2017 at the Agency’s premises in London. A list of the specific questions to be addressed, a summary of the safety concerns, information on how to participate and application forms, will be published at the beginning of July.