Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the implications for his policies of levels of disability in children of men who have been prescribed sodium valporate.

Valproate is recognised to be associated with risks to children which can be disabling, when women take valproate during pregnancy and there are measures in place to ensure women are aware of the risks and the importance of using contraception while taking valproate to minimise the risk of a pregnancy being exposed to valproate.

There are concerns that children of men who have been prescribed valproate may also be at risk. A recent study was supplied to regulatory authorities across Europe including the United Kingdom’s Medicines and Healthcare products Regulatory Agency which suggested an increased risk of neurodevelopmental disorders in children when fathers took valproate. Unfortunately, errors were identified in the study that require reanalysis before conclusions can be drawn, and more information on this is available at the following link:

https://www.gov.uk/government/news/safety-of-valproate-new-study-on-risks-in-children-of-men-taking-valproate

Once this reanalysis has been completed the necessary regulatory action will be taken and information provided to healthcare professionals and patients. However, it is worth noting that the initial data did not suggest a risk of major congenital malformations and the risk of neurodevelopmental disorders was much lower than observed in studies when women take valproate during pregnancy.