Valproate Drug Safety Update
Published: 20/02/25
New resources have been developed to support healthcare professionals in the management of Valproate prescribing.
Valproate (as sodium valproate, valproic acid or valproate semisodium) is authorised for the treatment of epilepsy and bipolar disorder. Valproate is known to have potential risks of major congenital malformations or neurodevelopmental disorders in children when mothers take valproate during pregnancy. More recently, the risk of a range of neurodevelopmental disorders in children born to fathers taking valproate compared to other antiseizures medicines has been described.
Recent review and updated advice
Review by two specialists remains in place for all patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valproate.
The information considered by CHM and the advice issued is presented in a Public Assessment Report.
Advice for Healthcare Professionals to Provide to Patients:
do not stop taking valproate without advice from a specialist. This is because epilepsy or bipolar disorder may worsen without treatment
if you are on valproate, please attend any offered appointments to discuss your treatment and talk to a healthcare professional if you are concerned
if you wish to discuss family planning, please contact a healthcare professional.
The CHM noted that there is now a recommendation in place that male patients and their female partners should use effective contraception while taking valproate and for 3 months after stopping. Men will be made aware of the need to use contraception by information on the patient card provided when valproate is dispensed and that if they are planning a family, to discuss with their GP the need to be referred to a specialist to discuss other treatment options.
The drug safety update, along with the three resources are available by clicking the links below:
From 4th November 2024, the Ask for ANI scheme has no longer been available in pharmacies. However, the Safe Spaces scheme has continued in over 6,000 Pharmacies, Banks and Building Societies across the UK. The Safe Spaces scheme is overseen by Scottish Women’s Aid/Hestia.