EMA public hearing about valproate in pregnancy
26 September 2017
The European Medicines Agency (EMA) will today hold a public hearing about the risks of valproate and related drugs during pregnancy.
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.