Pregnancy: Sodium Valproate
The question
To ask the Secretary of State for Health and Social Care, what evidence (a) his Department and (b) the MHRA have on the numbers of people harmed by Sodium Valproate in pregnancy.
Answered by Ashley Dalton
Everyone who has been harmed from sodium valproate has our deepest sympathies. The Department does not collect information about the numbers of people harmed by sodium valproate in pregnancy.
The Medicines and Healthcare products Regulatory Agency has received 1,169 United Kingdom spontaneous suspected adverse drug reaction reports for sodium valproate related to use during pregnancy, from the initial licensing of the medicine up to 24 June 2025. The majority of reports relate to birth defects or developmental delays in the child.
These are well documented risks for women taking sodium valproate during pregnancy, and as such sodium valproate must not be prescribed to women under the age of 55 years old who are able to have children, unless two specialists independently consider and document that there is no other effective or tolerated treatment, and the patient fulfils the conditions of a Pregnancy Prevention Programme.
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