Post-publication note - June 2025
In June 2025, the safety and educational materials for valproate were updated in line with the regulatory position and to reflect feedback from stakeholders. Please find the latest materials in our June 2025 Drug Safety Update.
- the CHM has advised that a review by two specialists is required for initiating valproate in patients under 55 years of age but not for men who are already taking valproate
- three infographics have been produced to clarify in which situations review by two specialists may be required:
- a list of who might qualify as a specialist can be found at Valproate safety measures
- report suspected adverse reactions associated with valproate on Yellow Card
Reminder of previous advice for healthcare professionals:
Patients under 55 years of age starting valproate
- valproate must not be started in new patients (male or female) younger than 55 years unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply. For many patients, other effective treatment options are available to treat their bipolar disorder or epilepsy
- information on permanent reasons or compelling reasons as to why the reproductive risks may not apply to a patient may be sought from clinical guidance
Women and girls of childbearing potential currently taking valproate
- at their next annual specialist review, women and girls of childbearing potential receiving valproate should have their treatment reviewed using the revised Annual Risk Acknowledgement Form. At this review, if the patient has never been reviewed by two specialists either at initiation or annual review, a second specialist signature will be needed if the patient is to continue on valproate. Women do not need to be recalled for an additional review. Once a patient has received a treatment review by two specialists, subsequent annual reviews only require one specialist
Men currently taking valproate
- as a precaution, recommend that male patients and their female sexual partner use effective contraception (condoms, plus effective contraception used by female sexual partner) throughout the valproate treatment period and for 3 months after stopping valproate, to allow for one completed sperm cycle not exposed to valproate
- at their next regular treatment review, discuss with men on oral valproate treatment whether they are planning to father a child in the next year and if they are, refer to a specialist to discuss most appropriate treatment options
- advise men not to donate sperm during valproate treatment and for 3 months after stopping valproate
- if a female reports they are pregnant or planning a pregnancy with a man on valproate, refer them for prenatal counselling
- do not stop taking valproate without advice from a specialist. This is because epilepsy or bipolar disorder may worsen without treatment
Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗