Use of sodium valproate and other antiseizure drug treatments in England and Wales: quantitative analysis of nationwide linked electronic health records
Caroline E Dale, Rohan Takhar, Yat Yi Fan, Fatemeh Torabi, Michail Katsoulis, Samuel Kim, Andrew Lambarth, Christopher Tomlinson, Tim Wilkinson, Tanja Mueller, Amanj Kurdi, Mark Ashworth, Mamas A Mamas, Kamlesh Khunti, Ashley Akbari, Andrew D Morris, Munir Pirmohamed, Anthony G Marson, David Williams, David Hunt, Cathie Sudlow, Reecha Sofat, on behalf of the CVD-COVID-UK/COVID-IMPACT Consortium
Sodium valproate/valproic acid is a teratogenic medicine highlighted as being of particular concern in the Cumberlege report ‘First do no Harm’ (July 2020), which aimed to reduce harm from medicines and devices. When used in pregnancy sodium valproate can be associated with a range of adverse effects including risk of spontaneous abortion, birth defects and neurodevelopmental disorders (autism, autism spectrum disorder, attention deficit/hyperactivity disorder and reduced IQ).
Key recommendations in the Cumberlege report, subsequently accepted by the UK Government, included establishing a registry of all women on anti-epileptic medicines who become pregnant, and the strengthening of the Medicines and Healthcare products Agency (MHRA) advice that “valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme (PPP) in place”. However, the Cumberlege report and the UK Government’s response were published during the COVID-19 pandemic when there was considerable disruption to services including medicines prescribing. There are no data on how or if Cumberlege has impacted on the use of sodium valproate in pregnancy at the national level.
The aim of this study was to; (i) investigate recent trends in the use of anti-epileptic drugs (AEDs), including sodium valproate, by women of childbearing potential (CBP) in England and Wales; (ii) to track aspects relating to implementation of the recommendations and response to the Cumberlege report; and (iii) to assess the impact of the COVID-19 pandemic on the report and the implementation of the Government’s response.
Published in BMJ Medicine: https://doi.org/10.1136/bmjmed-2023-000760 (citation to follow)
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This is a sub-project of project CCU014 approved by the CVD-COVID-UK / COVID-IMPACT Approvals & Oversight Board (sub-project: CCU014_03).
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