IMPORTANT: Do not stop taking prescribed medication without consulting your doctor or epilepsy nurse. If you are concerned, please contact the helplines of Epilepsy Action (0808 800 5050) or Epilepsy Society (01494 601 400).
Anti-seizure medications and epilepsy have received a lot of attention in the media in the past few years. Most notably was a story run by The Sunday Times in 2022, highlighting the devasting harm sodium valproate has caused some women and their babies. Today, there are still many questions left unanswered that have often been reported in the media. Questions on the risk of sodium valproate and other anti-seizure medications, questions on the potential transmission of risk via paternal exposure and questions about whether too much folate may be associated with later childhood risks. It certainly has been a concerning 24 months for the epilepsy community.
But why are we here? Why in 2023 are there still rising concerns around anti-seizure medications which have been used for decades? It’s simple. We accepted a default that a lack of evidence of risk equates to evidence of safety. We’ve accepted long latencies between medication approvals and adequate risk and safety data and academic review articles concluding time and time again that “more data is needed for conclusions to be drawn”. Despite our lack of knowledge and evidence, we are surprised when new studies deliver unwanted results.
In 2014, and again in 2018, medication regulators in Europe issued increasingly strong warnings that exposure in the womb to sodium valproate (also known as valproic acid, epilim, depakine and other brand names) 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 commonly 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.
Change started in the form of a steady decline in prescribing the drug, as evidence of its risks to the foetus came to light. Then came substantial regulatory intervention to reduce further the number of exposed children. But these changes occurred after decades of use and we are now tasked with understanding what lessons can be learnt and what additional change can be made.
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.
Being more responsive to patient concerns was at the centre of the 2020 First Do No Harm Review. Patient-led campaigns were certainly at the forefront of the changes which occurred with valproate; although it took time for their voices to be heard. Without the campaigning from patient groups I am unsure as to whether we would have seen such significant regulatory intervention. 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. You can read more about how the evidence base evolved and led to the changes in the policy and clinical practice in my earlier Research Blog here.
There are many contributing factors as to why it took time to bring about the significant changes needed. Most significantly maybe is that early reports or signals were not given the credibility they deserved. They were not followed up with well- funded rigorous studies immediately. The experience with valproate has led to changes beyond just that of the medications used to treat epilepsy. The First Do No Harm Review concluded that more change is required to optimise maternal and foetal health in pregnancy and this includes research into the other anti-seizure medications.
Whilst all the newly emerging risks regarding anti-seizure medications require replication and extension, we need to use 2023 as the year to demand more… more investment in research, more data, and, most importantly, more safety for people with epilepsy.
It is critical that I note my appreciation to Epilepsy Research UK. Research money is hard to come by and our group has had more disappointment than success – as is the way of academic life. As an early supporter of both the UK Epilepsy and Pregnancy Register and the Liverpool and Manchester Neurodevelopment Group, Epilepsy Research UK funded key initiatives including the UK contribution to the important NEAD study. They continue funding us today to maximise the safety of pregnancy for both mother and child.
As well as directly funding research into this area, Epilepsy Research UK is working to deliver a research roadmap and campaign to drive strategic investment through the #Every1EndingEpilepsy programme. Funded and led by Epilepsy Research UK, the programme aims to radically advance research into epilepsy through collaboration, investment and community action. Importantly, reproduction and hormones is one of the four cross-cutting research themes of the programme. I’m proud to be part of the #Every1EndingEpilepsy programme and to be working together, with the epilepsy community, to advance research into epilepsy.
-Dr Rebecca Bromley
IMPORTANT: Do not stop taking prescribed medication without consulting your doctor or epilepsy nurse. If you are concerned, please contact the helplines of Epilepsy Action (0808 800 5050) or Epilepsy Society (01494 601 400).
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