A welcome move by EMA on its first public hearing where Patients, carers, doctors, pharmacists and academia shared their experience and reviews on the usage of a medicine that treats epilepsy, bipolar disorder and migraine called Valproate. The safety and usage of medicine on women and girls who are pregnant or of child bearing age was the nature of concern.
The hearing gave an opportunity to EU citizens representing a wide range of groups to express their opinions adding to the available scientific evidence in the evaluation of this medicine. The total number of attendees was 65, including 28 patients and patient representatives, 19 healthcare professionals and academics, 11 from pharmaceutical industry and 7 from media.
There were a total of 25 speaker contributions, grouped into 16 speaker slots. The public hearing concluded that Valproate use during pregnancy causes risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb.
The committee will take each and every input received from the participants and to publish an assessment report on steps to reduce the risk of valproate-containing medicines during pregnancy and in women of childbearing potential.