New valproate regulations, informed choice and seizure risk

New valproate regulations, informed choice and seizure risk

19 June 2024 | Heather Angus-Leppan, Rachel Arkell, Lance Watkins, Dominic Heaney, Paul Cooper, Rohit Shankar
Valproate is the most effective medication for generalized epilepsies and several specific epilepsy syndromes. It is also effective for bipolar disorder and migraine prevention. However, its use in women of childbearing potential is restricted due to its teratogenic effects, which are higher than for other antiseizure medications (ASMs). Regulatory restrictions have reduced valproate use, but the evidence for its safety in males is limited. The UK's 2024 regulations limit valproate use to those under 55, creating a gender divide in prescribing. The regulations do not align with ethical principles or the Montgomery principles of informed choice. They also fail to consider patient outcomes beyond reproduction. The MHRA has not provided sufficient data on the risks of valproate use, and there is a lack of government investment in monitoring its effects. The regulations may lead to increased seizure recurrence and SUDEP in patients who stop valproate. The MHRA should disclose all information and the minutes of discussions about valproate and other medications. There is a need for revised information packs, full disclosure of funding and conflicts of interest, and government-funded registries to monitor outcomes. The MHRA should also provide full and free reproductive options for those wishing to start valproate. The regulations should be suspended pending further review. The paper argues that the current regulations do not adequately consider patient autonomy and informed choice, and that more resources are needed for informed decision-making and outcome monitoring. The MHRA should also consider reversion to 2016 international guidelines.Valproate is the most effective medication for generalized epilepsies and several specific epilepsy syndromes. It is also effective for bipolar disorder and migraine prevention. However, its use in women of childbearing potential is restricted due to its teratogenic effects, which are higher than for other antiseizure medications (ASMs). Regulatory restrictions have reduced valproate use, but the evidence for its safety in males is limited. The UK's 2024 regulations limit valproate use to those under 55, creating a gender divide in prescribing. The regulations do not align with ethical principles or the Montgomery principles of informed choice. They also fail to consider patient outcomes beyond reproduction. The MHRA has not provided sufficient data on the risks of valproate use, and there is a lack of government investment in monitoring its effects. The regulations may lead to increased seizure recurrence and SUDEP in patients who stop valproate. The MHRA should disclose all information and the minutes of discussions about valproate and other medications. There is a need for revised information packs, full disclosure of funding and conflicts of interest, and government-funded registries to monitor outcomes. The MHRA should also provide full and free reproductive options for those wishing to start valproate. The regulations should be suspended pending further review. The paper argues that the current regulations do not adequately consider patient autonomy and informed choice, and that more resources are needed for informed decision-making and outcome monitoring. The MHRA should also consider reversion to 2016 international guidelines.
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Understanding New valproate regulations%2C informed choice and seizure risk