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Epilepsy Coalition – important valproate update

IMPORTANT: Do not stop taking prescribed medication without consulting your doctor or epilepsy nurse. If you are concerned, please contact the helplines of Epilepsy Action (0808 800 5050) or Epilepsy Society (01494 601 400).

A medicines regulatory policy published on December 12th 2022, for sodium valproate featured new safety measures for valproate-containing medicines to be put in place. 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.  

 

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 pending consultation by clinical and patient organisations. 

Following Freedom of Information requests and formal letters, the Epilepsy Coalition escalated concerns to the NHS and requested a meeting with the Secretary of State for Health and Social Care. You can 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 still await a response. 

The charities and our beneficiaries have requested to 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. The published policy is a significant shift in practice and may result in risk to patient safety. The Coalition has asserted 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.

MHRA and Sanofi have advised that a subsequent data review has been undertaken which highlights that the safety study has limitations. Sanofi states that these issues need to be resolved before final decisions can be made and MHRA has said it is ready to review this re-analysis as soon as it is available. 

The coalition has emailed the MHRA ahead of today’s meeting to express our serious concerns 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. 

We are appealing to Ministers and the MHRA to pause now and allow time for a considered response to be given to the recommendations made in our letter of March 23rd. 

As would be expected for any other condition and patient community, the benefits and risks of different treatments must be balanced to enable informed consent from the patient. For women, proposed policy improvements 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. The Coalition has offered its networks of people with epilepsy and affected by epilepsy to support.

IMPORTANT: Do not stop taking prescribed medication without consulting your doctor or epilepsy nurse. If you are concerned, please contact the helplines of Epilepsy Action (0808 800 5050) or Epilepsy Society (01494 601 400).

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