19 June 2024 | Heather Angus-Leppan, Rachel Arkell, Lance Watkins, Dominic Heaney, Paul Cooper, Rohit Shankar
Valproate is a highly effective medication for generalized epilepsies and specific epilepsy syndromes, but its teratogenicity and neurodevelopmental effects are significantly higher than those of other antiseizure medications (ASMs). The Medicines and Healthcare Products Regulatory Agency (MHRA) has implemented several regulatory restrictions, including the Pregnancy Prevention Programme (PPP), which requires "user-independent" contraception for women taking valproate. These restrictions have reduced valproate use and exposed individuals with epilepsy to a higher risk of seizures. The new regulations, effective January 2024, apply to all individuals under 55 years old, further complicating prescribing practices and patient care.
The review highlights ethical and legal concerns with the current MHRA regulations, particularly regarding informed patient choice and autonomy. It argues that the regulations do not align with the Montgomery principles and common law principles of English Law, which prioritize patient autonomy over the health of a future child. The review also discusses the impact of valproate on male fertility and the potential for epigenetic effects, noting that the MHRA has not released unpublished data on these areas.
The authors recommend that the MHRA should fully disclose all information and discussions about valproate, provide adequate resources for informed patient choice and outcome monitoring, and consider reversion to the 2016 international guidelines that focus on informed decision-making by patients. They emphasize the need for government-funded registries to track maternal and fetal outcomes and patient switching from valproate to other medications. The review concludes by calling for full compensation and support for those harmed by valproate and advocating for more transparency and patient-centered care.Valproate is a highly effective medication for generalized epilepsies and specific epilepsy syndromes, but its teratogenicity and neurodevelopmental effects are significantly higher than those of other antiseizure medications (ASMs). The Medicines and Healthcare Products Regulatory Agency (MHRA) has implemented several regulatory restrictions, including the Pregnancy Prevention Programme (PPP), which requires "user-independent" contraception for women taking valproate. These restrictions have reduced valproate use and exposed individuals with epilepsy to a higher risk of seizures. The new regulations, effective January 2024, apply to all individuals under 55 years old, further complicating prescribing practices and patient care.
The review highlights ethical and legal concerns with the current MHRA regulations, particularly regarding informed patient choice and autonomy. It argues that the regulations do not align with the Montgomery principles and common law principles of English Law, which prioritize patient autonomy over the health of a future child. The review also discusses the impact of valproate on male fertility and the potential for epigenetic effects, noting that the MHRA has not released unpublished data on these areas.
The authors recommend that the MHRA should fully disclose all information and discussions about valproate, provide adequate resources for informed patient choice and outcome monitoring, and consider reversion to the 2016 international guidelines that focus on informed decision-making by patients. They emphasize the need for government-funded registries to track maternal and fetal outcomes and patient switching from valproate to other medications. The review concludes by calling for full compensation and support for those harmed by valproate and advocating for more transparency and patient-centered care.