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Coalition statement on the use of Sodium Valproate


A coalition of 11 UK epilepsy organisations recently met with representatives of the Medicines & Healthcare products Regulatory Agency (MHRA) to discuss proposed MHRA changes to safety measures and policy relating to the use of sodium valproate.  

The coalition does not support the MHRA’s current position and believes the proposed regulations are fundamentally flawed without an adequate comprehensive risk/benefit assessment. The coalition considers the overall impact and consequences of the new regulations, as currently proposed, to be unsafe for people with epilepsy and will increase risks to life.

In the interests of reducing risk for people with epilepsy, the coalition wishes to explore conditions for future engagement with the MHRA but need assurances that there will be transparency and meaningful engagement in any discussions. The coalition is still waiting for a response from the Secretary of State to its letter here

Whilst engaging with the MHRA to seek amendments to the policy, the coalition wish to make clear that such engagements are not – and should not be seen – as an endorsement of the MHRA’s current position on sodium valproate.

Read the latest full coalition response to the MHRA here


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