What's the issue?
Sodium valproate is a medicine used to treat epilepsy. It is often prescribed under the brand name Epilim. For some people it might be the most effective epilepsy medicine. However, sodium valproate carries a higher risk than other anti-epileptic drugs (AEDs) of causing birth defects and developmental problems in babies if taken during pregnancy.
It is crucial that women do not stop taking their epilepsy medicines without talking to a healthcare professional first. Stopping your medication could be harmful for you, and if you’re pregnant, your unborn child. If you are worried about any of the issues discussed then please make an appointment with your doctor. For information on planning a baby for women with epilepsy please contact the Epilepsy Action Helpline on freephone 0808 800 5050.
In 2017 Epilepsy Action, Epilepsy Society and Young Epilepsy conducted a survey. The results showed that 1 in 5 (18%) women taking sodium valproate are unaware that taking it during pregnancy can harm an unborn baby.
Epilepsy Action believes that all women who are prescribed sodium valproate must be made aware of the risks. We also believe that all women with epilepsy should receive pre-conception counselling. More needs to be done to ensure that healthcare professionals are given the right time and resources to talk to women and girls with epilepsy about pregnancy. Ideally, they must know about the associated risks before they conceive.
On 24 April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) changed the licence for valproate medicines in the UK. Sodium valproate must no longer be prescribed to women or girls of childbearing age unless they are on the pregnancy prevention programme (PPP).
As part of the PPP, the prescriber must make sure the woman or girl understands the risk if she became pregnant while taking the medicine. They must also understand the need to take contraception while on the medicine. A risk acknowledgement form must be completed and signed during a review that must take place at least once a year.
In February 2018, the government announced an independent review into medicines and medical devices safety. The review will look at three “public health scandals”, including sodium valproate. The Cumberlege Review is ongoing and expected to publish its report later in 2019. You can find out more about the review here.
What we are doing
We have been working closely with the MHRA and others to ensure that women and girls of childbearing age are aware of the risks. We are also working to reduce the number of pregnancies exposed to valproate medicines to an absolute minimum.
We want to make sure that every woman who is prescribed sodium valproate is aware of the risks. We will work with other epilepsy charities and the MHRA to monitor how the new regulations and the toolkit are working.
We want all women and girls of childbearing age with epilepsy to receive pre-conception counselling. Previously, pre-conception counselling for women with epilepsy was a Quality Outcome Framework (QOF) indicator. However, the QOF was retired in 2014.
While the QOF indicator was in place, a 2013 survey highlighted that around a third of women with epilepsy had not received information about pregnancy and possible risks. Following the retirement of the QOF, this figure rose to almost half of women.
We have called for the reintroduction of the pre-conception counselling for women with epilepsy as an indicator. Following our calls the MHRA have recently confirmed that they are introducing a Quality Improvement Activity (QIA) to review and improve the prescribing of valproate.
We also believe that there should be an NHS audit or register of women with epilepsy. This could automatically highlight those who are taking sodium valproate and flag up the need to call them in for review. Annual reviews for people with epilepsy are recommended in NICE guidelines but are not mandatory.
On 28 February the UK’s House of Lords held a debate on the safety of medicines and medical devices, discussing issues around sodium valproate. We contacted a number of Lords to provide a briefing on the issues around sodium valproate. Many Lords spoke about the impact of sodium valproate, and Baroness Walmsley quoted our chief executive Philip Lee. You can read more about the debate here.
On 16 April 2019, Epilepsy Action’s deputy chief executive Simon Wigglesworth, gave spoken evidence at the Cumberlege Review into Medicines and Medical Devices Safety. He outlined the actions that the charity has taken over the years to raise awareness of the risks of taking sodium valproate. He also welcomed the recently revised Annual Risk Acknowledgement form, which has helped clarify when the PPP should be used, and the new Guidance Document on Valproate Use in Women and Girls of Childbearing Years. The Guidance Document was issued and endorsed by the Royal Colleges. It will support clinicians in the often challenging discussions and decisions that will have to be made with women, for whom valproate could be a life-saving drug. You can watch the review’s evidence sessions here.
We will continue to work with the MHRA and other charities, to ensure that all women who are prescribed sodium valproate are aware of the risks.
How you can get involved
We will be running a survey later in the year to monitor how well these new regulations are working. If you want to take part, then keep watching our page and social media for updates.
We want to hear your story. If you have been affected by any of the issues discussed, then please email firstname.lastname@example.org