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.
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.