Synopsis
Apply current MHRA valproate restrictions accurately to new and existing patients, communicate maternal and paternal reproductive risks without abrupt discontinuation, and maintain specialist, laboratory and documentation safeguards throughout bipolar treatment.
- Do not start valproate in a new patient, male or female, under 55 unless two specialists independently agree and document that no other effective or tolerated treatment exists or compelling reasons make reproductive risks inapplicable.
- For women and girls able to have children, valproate is used only when alternatives are ineffective or not tolerated and every Pregnancy Prevention Programme condition is met.
- Valproate is contraindicated for bipolar disorder during pregnancy; suspected pregnancy requires urgent specialist discussion, not abrupt unsupervised stopping.
Key red flags
A missed period, positive pregnancy test or intention to become pregnant during valproate treatment requires urgent specialist contact and supervised treatment planning.
Investigation priorities
Confirm age, new or existing status, indication, alternatives, reproductive context, specialist decisions and current forms.
Management branches
Valproate is proposed for the first time for a male or female patient younger than 55 years.
- Confirm diagnosis, exact product and licence, previous effective and tolerated alternatives and why valproate is being considered now.
- Obtain two independent specialist decisions and documentation that no effective tolerated alternative exists or compelling reasons make reproductive risks inapplicable.
Key medicines
Semi-sodium valproate oral tabletsFor an adult manic episode, the product recommends 750 mg daily by mouth in two or three divided doses, increased to the lowest effective dose; the usual total is 1000 to 2000 mg daily, individualised by response.