It is important to complete an individual risk assessment for your patient and to apply the principles of prescribing during pregnancy when looking at the available information and making treatment decisions. Check to see if a risk assessment has already been completed by the specialist team.
Untreated or inadequately treated epilepsy can have adverse effects on the mother and therefore on the foetus.
The Royal College of Obstetricians and Gynaecologists (RCOG) Green-top Guideline on Epilepsy in Pregnancy (No. 68) summarises the evidence on maternal and foetal outcomes in women with epilepsy (WWE). It provides recommendations on the care of WWE during the pre-pregnancy, antepartum, intrapartum and postpartum periods.
You should check if there is local guidance for you to use in your area.
The MHRA Drug Safety Update states that Valproate medicines (e.g. Epilim▼, Depakote▼) are contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met. This means a system of ensuring all female patients taking valproate medicines:
- have been told and understand the risks of use in pregnancy and have signed a Risk Acknowledgement Form
- are on highly effective contraception if necessary
- see their specialist at least every year.
There has been a further update on the MHRA review into safe use of valproate. The CHM has recommended a number of regulatory actions to further strengthen safety measures for valproate to be introduced in 2023.
- No one under the age of 55 (male or female) should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment.
- Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply.
The MHRA has provided temporary advice for management during coronavirus (COVID-19) for the Valproate Pregnancy Prevention Programme.
The Royal College of Psychiatrists hosts a very useful pan-college guidance on the use of valproate in women and girls of childbearing years
It is intended to provide practical information and guidance, and sources of further support, for clinicians involved with valproate. It gathers data, where available, on best practice and summarises consensus opinion from nineteen national bodies across the UK.
For any woman, abrupt cessation of valproate is dangerous and should not be undertaken.
Pregnancy outcome information
UK Teratology Information Service (UKTIS) provides detailed information on pregnancy outcomes for specific medicines including sodium valproate, carbamazepine, lamotrigine, levetiracetum, topiramate and gabapentin that may be helpful to inform discussions, risk assessments and decisions.
Each of the UKTIS summaries has corresponding Best Use of Medicine in Pregnancy (BUMPS) patient information.
The MHRA provides a quite detailed safety leaflet on epilepsy medicines and pregnancy to help patients and their families understand the risks.
The Royal College of Obstetricians and Gynaecologists (RCOG) epilepsy in pregnancy patient information leaflet is provided to help women understand their health and options for treatment and care.
The NHS website provides information on conditions in pregnancy including on epilepsy and pregnancy
The Medicines A-Z has a summary statement on the use in pregnancy for each of the common anti-epileptic medicines including sodium valproate, carbamazepine, lamotrigine, levetiracetam and topiramate.