New MHRA guidance increases risk for people with epilepsy
We believe the lack of MHRA transparency and consultation on the Prevent Programme is outside the range of reasonable and acceptable.
Voices of concerned people with epilepsy not being heard
Since 2022, we have expressed our concerns that the voices of people with epilepsy – and the clinical organisations supporting them – are not being listened to, regarding decisions taken over the use and availability of lifesaving anti-seizure medications.
We fully support providing people with information on the known harms of medicines, but we have been shocked to see the UK move in directions that are out of step with other leading western countries in its approach to evidence-backed processes and informed consents. Consequently, it’s our view that many recent changes in guidance and regulations have made people with epilepsy less safe and more at risk of serious harms.
SUDEP Action and other patient organisations tried hard to engage with the MHRA and the Secretary of State in December 2022 because we were surprised to hear the MHRA announce – without due consultation – new restrictions, meaning no one under the age of 55 would be newly prescribed sodium valproate unless two specialists agreed there was no other effective or tolerated treatment, or there were ‘compelling reasons that the reproductive risks do not apply’.
According to the MHRA, around one in nine babies born to mothers taking sodium valproate will have birth defects and approximately 30-40 of 100 will have learning difficulties. The MHRA also said there is a risk of reduced fertility in men and boys taking valproate. However, for around 10% of people with generalised epilepsies, valproate is the first-line defence against hospitalisation and the very real – and often underestimated – risk of sudden unexpected death in epilepsy (SUDEP).
Last week, SUDEP Action, along with other organisations, was briefed by the MHRA over further surprise regulatory updates. We expected a review of the previous policy, in light of recent research articles citing the extension of the valproate policy to men as ‘insufficiently unsubstantiated’. Instead, we were informed there would be an additional new requirement for men with epilepsy – and their partners – to use effective contraception in order to be considered for access sodium valproate. The MHRA guidance says new data suggests ‘a potential small increased risk of harm to children if valproate is used by a father at conception.’ However, they also clearly state this increase is only apparent in the study data when certain analysis is conducted (no significant increase was found in the raw data) and the research authors felt ‘no causal relationship could be established’. The study was unable to compare the risks faced by those taking sodium valproate with those who are not – to see if it is indeed higher because of their medication.
At least five national patient organisations called for an urgent delay so there could be proper engagement with the sector, but this was refused.
SUDEP Action believes the lack of MHRA transparency and consultation on the Prevent Programme is outside the range of what is reasonable or acceptable. So too, is the MHRA’s disregard for informed consent and shared decision-making.
We have now written to Wes Streeting, Secretary of State for Health and Social Care, to request an urgent review of the governance of the UK medical regulatory function and some immediate mitigations to alleviate the ongoing harms we are seeing, including escalating waiting lists.
See MHRA guidance here
