Epilepsy Coalition - Important Valproate Update
People affected by epilepsy are advised not to stop or alter prescribed medications. Charity helplines are available for information and support.
A medicines regulatory policy published on December 12th 2022, for sodium valproate contained new safety measures for valproate-containing medicines to be put in place in the coming months. The measures followed a review of the latest safety data by the Commission of Human Medicines and stipulated:
- All people under-55 (including boys and men for the ﬁrst time) that are prescribed sodium valproate to have two signatures from specialists documenting that no other suitable alternative medication has been effective or tolerated https://www.gov.uk/drug-safety-update/valproate-reminder-of-current-pregnancy-prevention-programme-requirements-information-on-new-safety-measures-to-be-introduced-in-the-coming-months
A coalition of UK epilepsy organisations came together in January 2023 to make an urgent call for a decision by the Medicines and Healthcare products Regulatory Agency (MHRA) to be paused because epilepsy clinical and patient organisations had not seen the scientific rationale for the policy and had not been involved or consulted.
Two Freedom of Information requests have been denied and three formal letters have not been responded to. On March 23rd the Epilepsy Coalition escalated concerns to the NHS and in a letter - with a call for action - to request to meet with the Secretary of State for Health and Social Care. Read the letter here.
We are calling for an urgent review and scrutiny of this policy; evidence of a commitment to invest in a minimum framework for the safeguarding of life and investment in research. We have received no answer to this.
The charities and our beneﬁciaries need to see and be consulted on the scientiﬁc basis for the regulatory decision that was published on December 12th and the impact it is likely to have on patient safety. This has not happened yet. Because the policy is published, and the policy is a dramatic shift in practice and risk, and is controversial, there is a lot of confusion and variation in how organisations and individuals have been responding since December.
The policy is also causing confusion internationally as it diverges from the practice of European / other countries around the world who are aware of a summary of a European research study and its limitations. They have either just added a sentence to their patient information leaflets or are keeping their policy under review as they wait for further research to be able to progress medicines regulatory policy.
We have just learnt from the MHRA and Sanofi that a recent thorough data review by the company, since the UK policy update of December 12th 2022 was published, considers the safety study has limitations https://www.sanofi.com/assets/dotcom/pages/docs/our-company/social-impact/responsible-business-values/information-on-sodium-valproate/depakine-website-statement-june-2023-en.pdf. Sanofi states that these issues need to be resolved before final decisions can be made.
Although there has not been openness in the UK, the study was reported in the spring to other countries. An example is given below of what the finding was, the limitations, and what another country decided to do. https://www.medsafe.govt.nz/safety/Alerts/Sodium_valproate_Epilim_use_in_people_who_can_father_children.asp
We have emailed the MHRA ahead of the meeting on the 21st to express our loss of confidence and to call for the gov.uk drug safety update of December 12th 2022 to be taken down immediately and that information is now released under the Freedom of Information requests of December 21st to us.
The charities and our beneﬁciaries need to see and be consulted on the scientiﬁc basis for the regulatory decision and the impact it is likely to have on patient safety. Ministers and the MHRA must pause now and allow time for a considered response to be given to the recommendations made in our letter of March 23rd.
The Coalition is concerned that medicines regulatory policy must be robust and that any change has regard to each person’s situation and life choices and is in proportion to the risks to patient safety. Valproate remains the most effective medicine for people who may experience life-threatening seizures and other harms https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2039891/; https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00246-4/fulltext
Patients need, with counselling, to have the option of shared decision-making, balancing the benefits and risks of different treatments to enable informed consent to treatment that would be expected for any other condition and patient community.
The Coalition is clear that our position does not prevent the government, the NHS and the MHRA moving to including epilepsy as a poorly served community in national and local planning of improvements. For women, this must include investing in the necessary workforce to ensure all women receive preconception counselling and an opportunity for shared decision-making and informed consent with the information they need to be able to engage. The Coalition has offered its networks of people with epilepsy and affected by epilepsy to support.
For all enquiries about the coalition contact jane.hanna@sudep,org
For press enquiries contact [email protected]