22-11-2014 | European Medicines Agency Valproate Ruling Explained

Background

The European Medicines Agency (EMA) is an EU regulatory body, responsible for the evaluation of medicines developed being used in the EU.

Valproate is a commonly used anti-epileptic drug (AED). It is also used in the treatment of other conditions including migraine and bipolar disorder. It is also sometimes known as valproic acid, sodium valproate or valproate semisodium.

A number of recent studies found developmental problems in up to 40% of young children exposed to valproate in the womb. These problems included delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability. Previous studies had found that children exposed to valproate in the womb were at increased risk of autism, ADHD and malformations such as cleft palate at birth.

The Ruling

Because of this, the EMA has decided to strengthen warnings on the use of valproate in women and girls.

What should I do now?

What happens next?

These recommendations must now be implemented in all EU countries. In Ireland, this will be the task of the Health Products Regulatory Authority (HPRA). All healthcare professionals will be notified of the new ruling and given educational materials. More information on this will be available shortly.