EMA public hearing about valproate in pregnancy

Posted Sep 26 2017 in Living with epilepsy

26 September 2017

The European Medicines Agency (EMA) will today hold a public hearing about the risks of valproate and related drugs during pregnancy.

The background to and aims of the hearing are outlined here (document downloaded from the EMA website), and you can follow the event live from 12:45 here (click ‘Public hearing’ tab).

Seizure control during pregnancy is very important; however, babies exposed to valproate (and related drugs) in the womb are at a significantly increased risk of congenital abnormalities and cognitive and behavioural difficulties. Some develop a condition known as foetal valproate syndrome, which is described here.

The EMA hearing will explore whether enough is being done to inform women who take valproate (and related substances) about the potential dangers during pregnancy. Ultimately, it will help inform new EMA recommendations about these drugs.

In February 2016, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a toolkit containing important information for healthcare professionals and women with epilepsy concerning valproate medicines in pregnancy. However, a review conducted by UK epilepsy charities has shown that this information is not reaching women with epilepsy as effectively as hoped. The MHRA is investigating this and fully supports today’s EMA hearing.

Emma Friedmann was not informed about the risks of  taking valproate during pregnancy, and she now cares for a son with foetal valproate syndrome. You can read her story here.

Epilepsy Research UK has funded groundbreaking research into the effects of exposure to antiepileptic drugs in the womb. Read more here.



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