Summary
The Medicines and Healthcare products Regulatory Agency (MHRA) are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study before conclusions can be drawn. No action is needed from patients.
For female patients, healthcare professionals should continue to follow the existing strict precautions related to preventing the use of valproate in pregnancy (Valproate Pregnancy Prevention Programme).
Valproate: re-analysis of study on risks in children of men taking valproate (MHRA, 30 August 2023)
https://www.gov.uk/drug-safety-update/valproate-re-analysis-of-study-on-risks-in-children-of-men-taking-valproate
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