Use of valproate medicines in pregnancy is associated with a 40% risk of persistent neurodevelopmental disorders and a 10% risk of physical birth defects.  Despite repeated communications on this risk, it is estimated that 400 women in the UK took valproate medicines during pregnancy in 2016.

Following a review of the situation across the EU, valproate is now contraindicated in women of childbearing potential unless they meet the conditions of a Pregnancy Prevention Programme, which will include a risk acknowledgment form to be completed and signed by the specialist prescriber and the patient in a review at least once a year.

Please see the letter attached for actions required from the healthcare system.

For details on the new regulatory measures, see the MHRA website.