What is it about?

In the UK and parts of Europe, stricter guidelines have been introduced for prescribing valproate and topiramate. These changes aim to reduce the chances of babies being exposed to these medicines during pregnancy and to lower risks to male fertility. Valproate is used to treat epilepsy and bipolar disorder and topiramate, epilepsy and migraines and other off-label use. However, they can cause birth defects and developmental problems in babies if taken during pregnancy. As a result, new regulations have been brought in to protect both women and men of childbearing age. Despite these changes, some doctors and specialists disagree on how strictly the rules should be followed-especially when it comes to men with generalised epilepsy, where the evidence behind the risks is not yet clear. This article looks at the science behind the UK’s latest prescribing guidelines and explores what they mean for patient care and future research.

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Why is it important?

This narrative review explores the latest UK regulatory changes for valproate and topiramate, including newly introduced restrictions for men and women of childbearing potential. By combining recent evidence with practical challenges in implementation, it highlights key safety concerns-such as teratogenic and reproductive risks-while underscoring the need for improved patient education, interdisciplinary collaboration and ongoing pharmacovigilance. With a dual focus on emerging data and real-world practice, this review offers timely insight into balancing therapeutic benefit with long term safety, and sets the stage for future research and patient-centred care.

Perspectives

I have written this article at the end of my professional journey which has been dedicated to meeting the complex care needs of people with epilepsy including minimising risks of harm in the pregnancy continuum to women and their developing babies. When you prescribe or manage patients on valproate or topiramate, you’re likely facing increased pressure to balance clinical efficacy and regulatory safety demands. I’m hoping this article will give you the evidence, context and regulatory rationale to support your decision making. I have highlighted the need to protect patients whilst staying compliant with evolving guidelines and the importance of communication, informed consent, and individualised, shared decision making. I have identified critical gaps in research, like long term effects, off-label use and patient outcomes-that you can explore, contribute to, or use to advocate for change. I hope this article stimulates your future professional journey.

Mrs Kim Morley

Read the Original

This page is a summary of: New regulatory measures for valproate in men and topiramate in women under 55 years: a narrative review, British Journal of Neuroscience Nursing, March 2025, Mark Allen Group,
DOI: 10.12968/bjnn.2025.0002.
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