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, if sodium valproate is taken during pregnancy it can cause birth defects and developmental problems in babies.
It is crucial that women do not stop taking their medication if they think they are pregnant before talking to their healthcare professional first.
A recent survey by Epilepsy Action, Epilepsy Society and Young Epilepsy, show that one in five (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 produces 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.
What we are doing
The MHRA will be putting in place more things to make sure all women taking sodium valproate are aware of the risks. We are working closely with them to make sure this information is good and that it is given to the right people. This includes the development of a toolkit for healthcare professionals and patients.
We want to make sure that every women 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. We are asking the National Institute for Health and Care Excellence (NICE) to reintroduce pre-conception counselling as a Quality Outcome Framework (QOF) indicator.
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 email@example.com
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 your 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.