Valproate banned in pregnancy

By Julie Griffiths on 24 April 2018

Epilepsy drug valproate must no longer be prescribed to women or girls of childbearing age unless they are on the pregnancy prevention programme (PPP).

The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines (Epilim, Depakote and generic brands) used to treat epilepsy and bipolar disorder.

The MHRA has warned that children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders, with up to four in 10 babies are at risk of developmental disorders and approximately one in 10 are at risk of birth defects if valproate is taken during pregnancy.

All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice.

A letter will be sent to all relevant healthcare professionals in the coming weeks outlining the new requirements and providing updated educational materials. NICE is also amending its guidelines where valproate is mentioned, to reflect the new regulatory position.

It is hoped that these measures, used across health sectors, will help reduce the number of pregnancies exposed to valproate medicines and will make sure all women and girls of childbearing potential are aware of the risks.

RCM professional advisor Rachel Scanlan said: ‘These are very welcome measures that will enable midwives to advise and support women about this issue.

‘We are actively putting this information out to our members including on social media and via the RCM’s website so that our members are informed about this important update.

‘We have also updated our online learning package on epilepsy and pregnancy to reflect these changes.’