Drug safety update: valproate and pregnancy
In February 2020 the MHRA issued a Drug Safety Update concerning pregnancy prevention in
women taking valproate. Although the risks of developmental disorders (in 30-40 per cent of cases) and congenital malformations (in around 10 per cent of cases) have been known for many years, evidence from patient surveys suggested there were still gaps in the implementation of the valproate pregnancy prevention programme.
Valproate should not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years) unless other options are unsuitable and the pregnancy prevention programme is in place. The Drug Safety Update sets out the steps that have been taken to reinforce this message, including the updating of NICE clinical guidance.
MHRA booklets for healthcare professionals and patients were also updated with additional sections to clarify the advice and strengthen the guidance.