FOI release

FOI - Numbers affected by Valproate

Case reference FOI2025/00751

Received 21 July 2025

Published 9 September 2025

Request

During our first meeting with Dr June Raine CBE and the Pharmacovigilance team in August 2013 it was stated approx 20,000 babies had been affected by Valproate in pregnancy since licensing in 1973 and have constantly repeated that figure since. Therefore our FOI Question 1. Where has the figure of 20,000 affected orginated from 2. Can MHRA please provide evidence that number of affected exists. We look forward to your reply

Response

See attached

Documents

• FOI2025_00751 (redacted).pdf (920.5 KB)
• MHRA INFACT meeting note 16 Aug 2013 final.pdf (147.3 KB)
• Usage data for antiepileptic drugs in pregnancy for INFACT.pdf (230.3 KB)

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