Sodium Valproate Syndrome – Are we repeating mistakes?

The firm is currently acting for approximately 15 families whose children have been affected by exposure in utero to the common anti-epileptic drug sodium valproate (Epilim). The firm expects the first such case to come before the High Court this Autumn.

Despite political statements and HSE provided genetic testing, our clients continue to experience a dearth of supports.

Furthermore, despite such HSE genetic testing finding sodium valproate to be the cause of our clients injuries, liability remains in issue in all cases. This, of course, adds to the families distress.

This is further compounded by recent reports that women are still not being informed of the risk of taking epilepsy drug sodium valproate whilst pregnant.

Although the risks of taking valproate whilst pregnant have been known since its availability in Ireland in the 1970s, for decades Irish women have been prescribed the drug without any warning from their doctors.

A report by the HSE estimates that between 153 and 341 children will have experienced a major congenital malformation and up to 1,250 children will have experienced a neurodevelopmental delay from exposure to valproate between 1975 and 2015. 30-40% of children who are exposed to valproate whilst in the womb will have developmental disorders and approximately 10% will have congenital malformations, according to Epilepsy Ireland.

In a survey by Epilepsy Ireland in 2020, it found that one in three women are unaware that taking sodium valproate (Epilim) whilst pregnant can cause learning and development problems in children. One in six were unaware that use of the drug in pregnancy can cause birth defects. Read more about the Sodium Valproate Scandal.

In 2018, the Oireachtas Joint Committee on Health (in line with international recommendations) published a report on fetal valproate syndrome (FVS) – also known as fetal anti-convulsant syndrome (FACS). Its recommendations were that;

a) A register should be created to record all women who were prescribed valproate during pregnancy.

b) A register should be created to record all persons affected by fetal valproate syndrome.

Neither of these registers have yet been established in Ireland.

c) That a full suite of services to assist families impacted by the taking of valproate whilst pregnant be established.

Our experience from our own clients is that families are still awaiting access to these promised services leaving them to pay privately thousands of euros for therapies and other costs.

The Minister for Health Stephen Donnelly committed to holding an inquiry into the historical use of valproate. However, over a year since this commitment was made this inquiry has yet to take place into the risks of sodium valproate in pregnancy and postnatally. The comparable UK report was highly critical of the information provided to women in that jurisdiction – our notes from that review can be found here.