In February 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Drug Safety Update concerning pregnancy prevention in women taking valproate. Although the risks of developmental disorders and congenital malformations – in approximately 30-40 and 10 per cent of cases respectively – have been known for many years, evidence from patient surveys suggested that there were still gaps in the implementation of the 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 (see updated education materials). The Drug Safety Update sets out the steps that have been taken to reinforce this message, including the updating of NICE clinical guidance. The MHRA booklet for healthcare professionals was also updated with additional sections to clarify the regulations and strengthen the practical guidance.