Communicating Information practice question: a 24-year-old with epilepsy offered a change to sodium valproate

When deciding the most important information for this patient, start from the regulatory position rather than from the pharmacology. Following the MHRA Drug Safety Update of January 2024, valproate must not be started in any new patient younger than 55 years — female or male — unless two specialists independently consider and document that there is no other effective or tolerated treatment, or that the reproductive risks do not apply. This patient is 24 and of childbearing potential, so the conversation cannot begin with dosing or with side effects: it has to begin with the fact that starting valproate at all requires that second independent specialist opinion, alongside the pregnancy prevention programme, the annual risk acknowledgement form and highly effective contraception. Valproate exposure in utero carries a risk of major congenital malformation of about 11% and of neurodevelopmental disorder in up to 30–40% of children.

The remaining options are all false. Folic acid does not mitigate the malformation risk of valproate — the MHRA has said so explicitly — and valproate is not safe to continue in pregnancy. The annual risk acknowledgement form is not a one-off: it must be completed with a specialist at initiation and at every annual review for as long as treatment continues. Valproate is prophylactic and is taken regularly; it has no role taken at the onset of a seizure. And no antiepileptic is stopped abruptly — sudden withdrawal precipitates seizures and can precipitate status epilepticus, so any withdrawal is tapered under specialist supervision.

Further information: MHRA Drug Safety Update, 'Valproate: organisation-wide safeguards must now be in place', January 2024; NICE NG217, Epilepsies in children, young people and adults.