EMA Launches New Safety Review of Prenatal Valproate Exposure

Deborah Brauser

March 10, 2017

A new safety review has been launched by the European Medicines Agency (EMA) into the use of valproate by women who are already pregnant or are of childbearing age, the agency announced today.

Its Pharmacovigilance and Risk Assessment Committee (PRAC) will also be organizing a public hearing in order to hear directly from European Union (EU) patients who have had experience with valproate-containing medications.

Although the agents are approved in the EU to treat bipolar disorder and epilepsy, and in some countries to treat migraines, the EMA conducted an earlier safety review in 2014 because of the increased risk for malformations and developmental problems after fetal exposure to the drugs.

After the 2014 assessment, the EU strengthened warnings on valproate use in women and girls. However, there's skepticism over whether those measures were actually effective and whether more recommendations are now needed.

The PRAC has never before held a public hearing as part of a safety review of a medication, but it "will give EU citizens a voice…and empower them to express their views on issues related to the safety of certain medicines and the management of risks," they said in a release.

After the committee conducts its first round of scientific evidence assessments, it is expected to set a date for the hearing during its June meeting. Information on the date, as well as how to register, will be displayed on the EMA's website.

"While the [new] review is ongoing, patients prescribed valproate who have any concerns about their medication should discuss them with their healthcare professionals," notes the agency.

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