SUDEP Action

Making every epilepsy death count
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Access to medicines – an update on sodium valproate

 

A coalition of epilepsy organisations came together in January 2023 following a MHRA announcement of new restrictions relating to access to Sodium Valproate. This involved an acceleration of the policy for girls and women and an extension of the policy for boys and men (Valproate: reminder of current Pregnancy Prevention Programme requirements; information on new safety measures to be introduced in the coming months - GOV.UK (www.gov.uk).

We raised concerns at a national level, as epilepsy clinical and patient organisations, because we were concerned about the safety of a policy providing a dramatic shift for clinical practice for the prescribing of medicine for epilepsy - a condition which is serious and can be suddenly life-threatening  [Coalition statement on the use of Sodium Valproate | SUDEP Action).

We worked through the summer to offer constructive feedback on patient materials with a view to reducing risk. These changes are needed so that patients and families can be empowered with all the information they need to make informed choices about their treatments – information that must include both medication side-effects, as well as risks to wider safety. We absolutely stand by the families who have been affected by valproate and not told about side-effects and harms from medicines. However, we also stand by people who have not had the opportunity to learn about and access life-saving treatments for epilepsy.  

Almost a year has passed since the original announcement that changes were to be introduced. Now, within months, we have been told that implementation of the policy will begin. We will be reviewing the public assessment report carefully, as this is being made available for the first time to epilepsy organisations and the public. 

We hope that the policy and materials, once made public, will have benefited from the time taken to reflect and listen to the concerns and input given by the epilepsy organisations since the policy changes were announced in 2022.

We hope that all those working in the NHS and Care systems will be given the time to safely take forward the policy - at a time when these systems faces unprecedented waiting times and access issues.

We hope too, that all people with epilepsy affected by this policy will receive personalised information on SUDEP and risk from their health professionals and will be informed about the EpSMon app and other helpful patient information and services which they can access, particularly via the epilepsy charities.  

SUDEP Action will remain engaged with the MHRA on this issue for as long as we feel we can have a positive benefit for people with epilepsy and the wider epilepsy community. We will continue to be alongside bereaved families and seek accountability and learnings as needed. We will also continue to call for openness of evidence and positive opportunities for engagement and balanced messaging, so that people can make informed choices about their treatment and safety.

It is important  that anyone taking epilepsy medications does not stop doing so. Please speak to the health professional who supports you with your epilepsy if you have any questions or concerns. 

For more information on understanding, managing and reducing epilepsy risks and improving safety, see: https://sudep.org/epilepsy-and-risk

For wider epilepsy support, these organisations can help: https://sudep.org/who-contact-help