MHRA Sodium valproate

https://www.gov.uk/drug-safety-update/valproate-and-developmental-disorders-new-alert-asking-for-patient-review-and-further-consideration-of-risk-minimisation-measures

Risks of exposure in pregnancy and previous communications

Babies exposed to valproate-containing medicines (Epilim▼, Depakote▼) in utero are at very high risk of developmental disorders and congenital malformations. After warnings were strengthened at the European level, in 2015 we advised you against prescribing valproate-containing medicines in girls and women of or nearing childbearing potential unless other treatments are ineffective or not tolerated.

In 2016 we released further communication materials and resources to support discussion of these risks with women and girls of childbearing potential who take valproate.

The MHRA’s toolkit resources have been disseminated widely. However, evidence suggests as many as 1 in 5 women taking valproate are not aware of any of its risks in pregnancy. Evidence from the Clinical Practice Research Datalink also suggests that, although prescription rates for valproate have been declining gradually in recent years, the measures put in place have not had a significant effect.

Audit

This search was ran previously and has been rerun today so that this could be put on the website.

We have no patients that are female under 60 on sodium valproate.

This has also been put on the pregnancy page of the website which was updated accordingly.

 

 

Comments are closed.