- updated safety and educational materials are now available to support healthcare professionals and patients to implement the existing regulatory requirements
- the updates reflect:
- precautionary advice on the potential risk of neurodevelopmental disorders in children fathered by men taking valproate around the time of conception
- a risk of lower weight at birth for the gestational age in children exposed to valproate during pregnancy
- healthcare professionals should review the new materials and integrate them into their clinical practice when referring patients and when prescribing or dispensing valproate
As a reminder
- 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
- valproate must not be prescribed to any woman or girl able to have children unless the conditions of the Pregnancy Prevention Programme (PPP) are followed
- as a precaution, recommend that male patients use effective contraception (condoms, plus contraception used by the 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. For further information see the September 2024 Drug Safety Update
- report suspected adverse reactions associated with valproate on Yellow Card
- do not stop taking valproate without advice from a specialist. This is because epilepsy or bipolar disorder may worsen without treatment
- women and girls who are able to have children and who are taking valproate must follow the conditions of the Pregnancy Prevention Programme
- as a precaution it is recommended that male patients taking valproate should use effective contraception (condoms, plus contraception used by the female sexual partner) throughout the valproate treatment period and for 3 months after stopping valproate
- if you are on valproate, please attend any offered appointments to discuss your treatment plan and talk to a healthcare professional if you are concerned. If you wish to discuss family planning, please contact a healthcare professional
- consult the Patient Information Leaflet and Patient Guide for men or Patient Guide for women for information about the risks of valproate – also the MHRA information page for information resources
Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗