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Valproate – MHRA Male Fertility Guidance — SCE Neurology MCQ

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ModerateEpilepsy & Seizure DisordersValproate – MHRA Male Fertility GuidanceSCE Neurology

A 40-year-old man with epilepsy controlled on valproate wishes to start a family with his partner. The MHRA has issued guidance about valproate use in males. What does this guidance state?

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Correct answer: B — The MHRA (2024) advises that valproate may affect male fertility (reduced sperm count and motility) and there is emerging evidence of potential teratogenic risk from paternal exposure — men should be counselled and a risk acknowledgement form completed

The MHRA issued updated guidance (2024) extending valproate risk assessment to males. Key points: (1) valproate can reduce sperm count, motility, and morphology (reversible on cessation), (2) animal studies suggest potential teratogenic effects from paternal exposure (though human evidence is limited), (3) men of reproductive potential should be counselled about these risks, (4) a risk acknowledgement form should be completed (similar to the Pregnancy Prevention Programme for women), (5) alternative AEDs should be considered if appropriate. A: Males are also affected. C: Both sexes are affected. D: Valproate impairs male fertility. E: Specific MHRA guidance exists.

Reference: MHRA Valproate Guidance (2024); NICE NG217