Sodium Valproate

Department of Health and Social Care written question – answered at on 22 June 2023.

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Photo of Charlotte Nichols Charlotte Nichols Labour, Warrington North

To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare Products Regulatory Agency is taking steps to investigate the potential effect of valproate on men and their fertility.

Photo of Maria Caulfield Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

Valproate is a medicine authorised for the treatment of epilepsy and bipolar disorder. The product information for all medicines is approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The product information for valproate containing medicines has listed male infertility as a possible side effect since 2011.

In 2021, the MHRA reviewed the totality of data on the risk of male infertility associated with valproate including evidence for reversibility of effects. Although the data are limited, the valproate product information was updated in 2021 to advise that male infertility is usually reversible after treatment discontinuation and may be reversible after dose reduction. However, in some cases, the reversibility of male infertility was unknown.

The underlying biological mechanism is currently uncertain, but animal data on valproate show toxicity to testicular tissue structure and function. MHRA keeps all data under review and is investigating the clinical relevance of these data with the marketing authorisation holders.

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