January Epilepsy Blog UK

Epilepsy in Pregnancy
Making sure women’s voices are heard

Children who are exposed to certain prescribed medications in the womb can be at risk of poorer physical or neuro development. Over the past decade, research funded by Epilepsy Research UK has led to changes in policy and clinical practice relating to the use of epilepsy medication during pregnancy, including sodium valproate. On the Research Blog this month, we look at epilepsy during pregnancy, the journey in recognising the risks associated with sodium valproate and how research into epilepsy can make pregnancy safer for both mother and baby.

After being diagnosed with epilepsy when she was seven, Faye was able to control her seizures with medication for most of her life. However, becoming pregnant in 2014 provoked her epilepsy and ended a seizure-free run of two years. She found there was little support available for women like her with epilepsy during pregnancy.

“I’d always considered myself quite clued up on my epilepsy… life had other ideas for me,” Faye says. “I realised I knew little of the journey I would take as a woman having a child, and that if I felt this way then so would many others.”

Faye began blogging to share her experience and was overwhelmed with the response she got from other women in the same situation. “I found myself in a position to be the support to women that I so badly needed when I was pregnant.”

Sodium valproate is an effective antiepileptic drug (AED) that can also be prescribed for bipolar disorder and migraines. From the early 1970s, valproate was widely used as a treatment for epilepsy. But by the mid-1980s, doctors started reporting cases of physical birth abnormalities in children born to mothers who took valproate during pregnancy. Further research showed that valproate was also linked to developmental delays and long-term learning difficulties in children.

In all, it’s estimated that using sodium valproate during pregnancy carries a 1 in 10 risk of a physical birth abnormalities and 4 in 10 risk of a developmental delay or autism. But it took until 2018 for the European Medicines Agency to ban the use of valproate in women of childbearing age unless they are on a pregnancy prevention plan.

Why did it take so long for the concerns about the effects of sodium valproate to be properly recognised? A 2020 investigation led by Baroness Julia Cumberlege aimed to find out. The Independent Medicines and Medical Devices Safety Review found that not enough credibility was given to the early reports of birth defects – in short, the voices of women with epilepsy and scientists were not being listened to.

Research funded by Epilepsy Research UK and carried out by Dr Rebecca Bromley provided key evidence that sodium valproate was harming unborn babies. Alongside the efforts of campaigners, this work provided the evidence needed to drive change.

On the Research Blog later this month, Rebecca will provide an update on what has happened since the Cumberlege Review. She will also talk about her Epilepsy Research UK-funded work investigating the impact of seizures during pregnancy on children later in life.

The Cumberlege Review provided a timely reminder that there is much more research needed to make pregnancy safer for both women with epilepsy and their unborn children. Kim Morley is a midwife and nurse who specialises in epilepsy. On the Research Blog later this month, Kim will share her journey in providing care to women with epilepsy, and how being a voice for these women has contributed to highlighting their specific needs as well as developing her involvement in research.

The central finding of the Cumberlege Review was that the voices of people affected should have been listened to, but were not. In spite of this, Dr Rebecca Bromley believes that patient-led campaigns combined with research evidence were crucial for driving the changes in the use of valproate.

“Without the campaigning from patient groups I am unsure as to whether we would have seen such significant regulatory intervention,” Rebecca says. “Having attended many regulatory review meetings, it was the patient campaigners, I believe, that brought the severity of the possible deficits to life; in a way the research evidence alone was failing to do.”

To keep the pressure on and the momentum going, the Valproate Stakeholders Network was formed in 2016. It includes representatives from the MHRA (the UK medicines regulator) and epilepsy charities, including Epilepsy Research UK, as well as healthcare professionals. But most importantly, the network also involves people affected by sodium valproate and epilepsy during pregnancy, including Faye.

Next week on the Research Blog, Faye shares her own experience of pregnancy and motherhood and her role as a patient representative. Faye is determined to ensure that the voices of pregnant women with epilepsy are not ignored again. “My passion is to give women a voice and then a choice, especially when it’s something as important and life-changing as becoming a Mum.”

Keep an eye on the Research Blog in January, where Faye, Rebecca, and Kim will be sharing their perspectives on sodium valproate and epilepsy during pregnancy. They’ll also be speaking at our Research Roundtable webinar later this month – sign up to our E:Bulletin to be notified of when you can register for the session.

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