12 October 2023
- Rate of women with epilepsy dying sudden death during and after pregnancy nearly doubles during period in which restrictions on key medication introduced, new MBRRACE report shows.
- Report also highlights wider issues in excluding pregnant women from clinical research, and urges that the benefits and risks of medications and vaccines are properly communicated so women can make their own informed choices about what is right for them.
- Too often, a focus on the fetus - whether real or hypothetical - can compromise the care a woman of reproductive age receive may receive.
Findings from the 10th MBRRACE-UK report of Saving Lives, Improving Mothers' Care raise serious issues surrounding how the risks and benefits of medications, including vaccination, are communicated to women in relation to pregnancy, with concerns about potential harm to the fetus sometimes outweighing the health needs of women themselves. The report highlights the initial confused messaging about the safety of the Covid vaccine in pregnancy due to lack of research evidence, and consequent widespread vaccine hesitancy amongst clinicians and pregnant and postpartum women. A total of 45 women died from COVID-19 pneumonitis between March 2020 and December 2021. Thirty-three of these women died during or up to six weeks after the end of pregnancy and a further 12 women died more than six weeks after the end of pregnancy. Only one woman who died from COVID-19 pneumonitis had received any vaccine doses.
Seventeen women died during or up to a year after the end of pregnancy in the UK and Ireland in 2019-21 from causes related to epilepsy, of whom 14 died from Sudden Unexpected Death in Epilepsy (SUDEP). The SUDEP death rate represents a near doubling of the rate of SUDEP between 2013-15 and 2019-21, which corresponds to the period in which the MHRA introduced new restrictions on access to Sodium Valproate, a seizure control medication, for women of reproductive age. Sodium Valproate has been at the centre of controversy because of the historic failure to inform women about its potential to increase the risk of fetal abnormalities and developmental delay in children if taken during pregnancy, causing huge harm to women and their families. The new framework however goes beyond principles of informed consent which apply to the provision of other medications, with valproate no longer able to be provided to women of childbearing age unless it is the only medication suitable and she has a Pregnancy Prevention Programme (PPP) in place. As a result, large numbers of women of reproductive age have undergone a medication change even if they have no intention of becoming pregnant, with the potential of poorer seizure control as result. None of the women who deaths were reported in the MBRACCE analysis were using Sodium Valproate.
Clare Murphy, BPAS Chief Executive, said: "There are some very troubling figures in this report. The current approach to restricting what for many women may be a life-changing, and indeed life-saving medication may have serious consequences that we have not properly considered. The focus can not be solely on risks to a fetus - real or potential. The risks to women's health matters too, and women need to be able to make their own decisions, with access to specialist advice and support, about how to negotiate those risks to achieve the best possible outcomes for themselves and their pregnancies. We echo calls for pregnant, recently pregnant, and breastfeeding women to be treated the same as a non-pregnant person unless there is a very clear reason not to do so."
Rachel Arkell, PhD candidate at the University of Kent who has undertaken extensive research with specialists who prescribe for women with epilespy said: "Many consultants with valproate prescribing responsibilities have found the inflexibility of the Pregnancy Prevention Plan extremely challenging. The message of 'avoid valproate at all costs' means that many feel they can no longer recommend a medication that they feel may be the most effective for the woman in front of them. One clear recommendation emerging from the consultants I spoke with is for the MHRA to start collecting balanced, comprehensive data on patients where valproate would be clinically indicated. This should include incidents such as hospital admissions, seizure related injuries and SUDEPs, so a clearer picture of the consequences of the guidance can be established."
The full report can be found here: https://www.npeu.ox.ac.uk/assets/downloads/mbrrace-uk/reports/maternal-report-2023/MBRRACE-UK_Maternal_Compiled_Report_2023.pdf
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The British Pregnancy Advisory Service, BPAS, is a charity that sees over 100,000 women a year for reproductive healthcare services including pregnancy counselling, abortion care, miscarriage management and contraception at clinics across Great Britain.
BPAS exists to further women’s reproductive choices. We believe all women should have the right to make their own decisions in and around pregnancy, from the contraception they use to avoid pregnancy right the way through to how they decide to feed their newborn baby, with access to evidence-based information to underpin their choices and high-quality services and support to exercise them.
BPAS also runs the Centre for Reproductive Research and Communication, CRRC. Through rigorous multidisciplinary research and impactful communication, the CRRC aims to inform policy, practice, and public discourse. You can find out more here.