Recent media coverage of the drug sodium valproate has highlighted that, despite many years of research and campaigning that led to changes in policy and practice, the drug has still occasionally been prescribed to pregnant women with epilepsy, sometimes without discussion about the potential risks posed. In this piece, we share the response from our Chair, Professor Matthew Walker, on the importance of all women being informed of the risks associated with taking the anti-epileptic drug during pregnancy. We also provide information about how research funded by Epilepsy Research UK, in association with patient campaigning, influenced the changes in policy and practice introduced through the Cumberlege report around the prescribing of valproate. And we reflect on the work still to be done to ensure risks are managed for all women and babies.

In a statement responding to the story, Epilepsy Research UK Chair Professor Matthew Walker said: We strongly support the MHRA position that all women with epilepsy are informed of the risks of valproate and other anti-epileptic seizure medications during pregnancy. Unfortunately, for some women, valproate is the only medication that controls their epilepsy. More research is needed to identify safe alternatives. We also support greater access of all people with epilepsy to clinicians with expertise in epilepsy so that they can be offered the best and most up-to-date advice.

Dr Rebecca Bromley, a Neuropsychologist and researcher at the University of Manchester, has studied the use of antiepileptic medications in pregnancy for over 15 years. Dr Bromley’s ERUK-funded research provided key evidence which led to changes in policy and clinical practice, reducing the risk to countless babies of women with epilepsy. She discussed the journey to recognising the risks associated with sodium valproate, and how patient campaigning and research brought about vital change, in a recent blog. 

 In 2014, and again in 2018, medication regulators in Europe issued increasingly strong warnings that exposure in the womb to sodium valproate was associated with wide-ranging risks to foetal development. The recommendation was that use in women in their childbearing years should be avoided if possible. Valproate was widely licensed in the 1970s and had become one of the most prescribed medications around the world for epilepsy. An important and life-saving drug for some, over time became known to convey an increased risk of birth defects and lifelong developmental problems. 

After decades of use, there was a decline in the prescribing of sodium valproate as evidence of its risks to the foetus came to light. This was followed by a substantial regulatory intervention to further reduce the number of children exposed to the drug.  

Dr Bromley continues, “Documenting the risk associated with exposure to valproate in the womb was incredibly important. After all, we are talking about a preventable cause of physical and learning disability. Research was key to the changes made regarding the use of valproate, but the slow accumulation of evidence undoubtedly led to more children being exposed to valproate than was ultimately necessary. Change happened, but not soon enough and we need to look at how we do better.” 

The 2020 First Do No Harm Review put responding to patient concerns around valproate at the centre of the issue. Although it took time for their voices to be heard, patient-led campaigns were at the forefront of the changes. As Dr Bromley 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. These patient groups used the research evidence to argue for change. They wanted valproate to only be used when absolutely necessary and when woman had all the relevant information. The combination and collaboration of the research evidence and international patient campaigning were central to the changes we’ve seen for valproate regulation.” 

“As both Faye and Professor Walker have stated, sodium valproate has provided many women with a seizure-free life. But careful consideration is needed when planning pregnancy, no matter what anti-epileptic drug you are taking. It is essential to speak to your epilepsy nurse or neurologist before discontinuing any medications.” 

You can read Dr Rebecca Bromley’s full Research Blog here.

Related reading:

Faye Waddams’ Research Blog – a voice for women with epilepsy

Kim Morley’s Research Blog – epilepsy in pregnancy in the clinic

You can also watch Faye, Kim and Rebecca in our Research Roundtable webinar, where they joined us for a deeper dive into their various experiences in epilepsy and pregnancy, including impactful advocacy work, pioneering clinical practises and game-changing research.