Today (08/07/20) the Independent Medicines and Medical Devices Safety Review (IMMDSR) was published, titled ‘First Do No Harm’.
Two years in the making, this review details the ways in which people have suffered avoidable harm through Primodos, pelvic mesh and sodium valproate.
It urges the government to make a ‘fulsome apology’ to women and families affected by these issues and makes recommendations to improve the health system to avoid further harm.
Sodium valproate is an epilepsy medicine which can be very effective in controlling seizures in some women, however it has been found to increase the risk of birth defects and developmental problems in children when taken by women during pregnancy.
As a result, in 2018 the European Medicines Agency put restrictions on its use for women of childbearing age.
Following this new guidance, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) took steps to establish the Pregnancy Prevent Programme.
This programme is designed to support women to avoid pregnancy whilst taking sodium valproate and monitor their care if they do decide to have a baby.
Premenopausal women in the UK should not be prescribed sodium valproate unless they are on the programme.
The IMDDSR review
The IMDDSR review highlights that, despite the Pregnancy Prevent Programme, women are still becoming pregnant whilst taking sodium valproate without any knowledge of the risks.
Epilepsy Scotland welcomes this long overdue review and will lobby to see the recommendations implemented as quickly as possible. As a charity, we continue to encounter women who are uninformed and falling through the cracks.
The potentially negative effects of sodium valproate were first identified in the 1970’s. Over the last forty years, however, thousands of women and children have been affected by a lack of support and information about the risks of sodium valproate.
The review details the avoidable trauma and lifelong damage experienced by both mothers and their children due to systemic failings, a culture of medical paternalism and a lack of specialist care for this group.
This report pulls no punches; it is a wakeup call that the system failed thousands of women with epilepsy over several decades.
Despite the ongoing efforts of many dedicated and caring clinicians, shortcomings still persist – more needs to be done to support GPs, community pharmacists and epilepsy specialists to ensure no more avoidable harm is experienced by women with epilepsy and their children.
This is a UK-wide review and the recommendations regarding sodium valproate are appropriate and relevant in Scotland.
In particular, we need a more systematic way of identifying women at risk. At present there is no patient register for epilepsy in Scotland – such a national database could play a pivotal role in identifying women, tracking outcomes and avoiding harms.
For some women with epilepsy, sodium valproate may be the only drug which controls their seizures, and for them the choice of whether or not to take it can be a difficult one.
However it should be a fully informed choice, where they are empowered with the facts and supported to balance or mitigate risks where possible.
Are you taking Sodium Valproate?
If you are a woman of childbearing age who is taking sodium valproate and have not had the Pregnancy Prevent Programme discussed with you, we urge you to speak to your GP and/or epilepsy specialist.
You should not stop taking your medication without consulting your epilepsy specialist first. Any medication changes should be done through your epilepsy specialist to ensure your safety.