FOI release

Copy of post-authorization safety study (PASS) to evaluate paternal exposure to valproate

This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2024/00798

Received 16 December 2024

Published 17 January 2025

Request

In January 2024, the MHRA changed its guidance to doctors who wish to start males aged under 55 on a new course of valproate to treat epilepsy. In September 2024, further guidance to men was issued, which included the need to use contraception if taking valproate, and to stop valproate before trying to father a child. Both measures were based upon the EMA’s safety committee's (PRAC) recommending certain precautionary measures for the treatment of male patients with valproate medicines, based upon a retrospective observational study carried out by companies that market valproate. This study was shared with the MHRA. This post-authorization safety study (PASS) evaluating the paternal exposure to valproate and the risk of neurodevelopmental disorders has the EU PAS number EUPAS34201 and the Study ID: 50599 I would like to request a copy of the above study upon which the MHRA based its decision. Thus far, only an assessment report has been placed in the public domain. (https://www.gov.uk/government/publications/valproate-paternal-exposure-to-valproate-and-risk-of-neurodevelopmental-disorders-and-congenital-malformations-in-offspring)

Response

see attached

Documents

• FOI2024_00798 redacted for publication.pdf (102.7 KB)

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