Conference on foetal valproate syndrome

Caused by taking specific drug during pregnancy
  • Deborah Condon

The detrimental impact of taking the epilepsy drug, sodium valproate, while pregnant was highlighted as part of a major conference recently.

Sodium valproate, sold in Ireland as Epilim, is a medicine licensed to treat epilepsy and bipolar disorder. However, if a woman becomes pregnant while taking this drug, her baby is at risk of experiencing serious birth defects and developmental disorders. This is known as foetal valproate syndrome.

Due to growing evidence, in February 2018, the European Medicines Agency recommended new restrictions on the use of the drug, including a pregnancy prevention programme.

In reponse to this, the HSE developed a detailed patient communication and support programme, in order to inform patients and healthcare workers about the risk of taking sodium valproate during pregnancy. This was done in partnership with healthcare experts and patient advocates from Epilepsy Ireland and OACS Ireland. It also supported the work of the Health Products Regulatory Authority (HPRA).

The recent conference was hosted by the HSE, Epilepsy Ireland and OACS Ireland, with the aim of bringing together patients and families who have been affected. Clinical experts were also on hand to share the latest information.

The conference also reviewed the work undertaken last year to update and contact patients who may have been unaware of the risks of taking this drug during pregnancy.

"Our priority in 2018 was firstly to remind patients taking Epilim of the risk of taking this medicine while pregnant. We also wanted to make contact with people who may have taken Epilim during a previous pregnancy, and may have had concerns about their child. This conference follows that work to identify and support people affected by foetal valproate syndrome," explained Dr Colin Doherty, a consultant neurologist at St James's Hospital and HSE clinical lead for women's health in epilepsy.

Also speaking at the conference, Prof Amanda Wood, of Aston University in the UK, pointed out that there are still ‘significant gaps in our knowledge about the longer term outcomes' for children who were exposed to this drug while still in the womb.

"We are committed to ensuring that surveillance of neurodevelopmental effects occurs early for new medicines, including anticonvulsants. The valproate story holds many lessons for the importance of fundamental research that provides an evidence base from which women can make informed decisions about their healthcare," she said.

Meanwhile, according to Peter Murphy, CEO of Epilepsy Ireland, this conference is a ‘landmark' for families that have been affected by sodium valproate.

"Real progress has been made over the past year by the joint efforts of patient advocacy groups and state bodies such as the HSE and HPRA, particularly in communicating the risks of valproate in women and proactively putting in place measures to reduce these risks in future.

"By bringing together families, health professionals and policy makers, we are launching an important conversation, which I hope will now act as a springboard for implementing the diagnostic and support services that families across the country deserve and urgently require," he commented.

The conference was told that during 2018, the HSE's patient support team provided expert support to anyone with concerns about previous exposure and the potential impact on their children.

"About 40 families came in touch with this team, most of whom were already known to the health services, and we were able to discuss their experience of Epilim, and if required, to refer them to a specialist team or to HSE-funded counselling supports," explained Dr Colm Henry, HSE chief clinical officer.

The HSE also noted that a specialist paediatric consultant has been appointed to Our Lady's Hospital, Crumlin, to support the medical diagnosis of foetal valproate syndrome. The HSE is also working to improve access to genetic testing and diagnosis.

The conference took place in Trinity College Dublin. For more information on sodium valproate, click here.


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