EMA’s PRAC to Hold First Public Hearing on Use of Valproate Medicines

Regulatory News

The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its first public hearing on 26 September 2017 to discuss the safety of using valproate-containing medicines in the treatment of various conditions for women and girls who are pregnant or of childbearing age. 

The public element of the meeting means EU citizens will be invited to share their experiences with these medicines, which are approved nationally in the EU to treat epilepsy, bipolar disorder and in some countries, migraines, according to EMA.

In 2013, the US Food and Drug Administration (FDA) advised health professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, "are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant."

PRAC Meeting

The European regulator said Friday that a list of specific questions for the public, a summary of safety concerns and information on how to participate will be published at the beginning of July.

The decision to hold the meeting follows the adoption of rules of procedure on the organization and conduct of public hearings and a simulation training in 2016.

Also on Friday, EMA announced that PRAC has concluded that there is no evidence of a change in the known risk of neutropenic enterocolitis after treatment with docetaxel, a cancer medicine.