• EPILEPSY

The decision by the UK Medicines and Health Care products Regulatory Agency (MHRA) to impose severe restrictions on the prescribing of valproate for men under 55 years1 2 seems to be unwise, based on tenuous scientific underpinnings, and potentially dangerous for boys and men with epilepsy. In the UK, from January 2024, ‘valproate must not be started in new patients, male or female, younger than 55 years unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply’.1

Undoubtedly, valproate use in women poses major hazards to the unborn child, including increased risks of major congenital malformations3 and neurodevelopmental disorders.4–6 Despite a decline in valproate prescribing in women, many pregnancies continue to be exposed to valproate.7 This justifies efforts to improve compliance with existing restrictions,8 even though the wisdom of requiring an independent intervention of two specialists has been questioned.9

Should similar restrictions on valproate prescribing also apply to men? Case reports indicate that valproate can affect sperm count, motility and morphology.10 However, male infertility is considered to be rare11 and reversible after treatment discontinuation or dose reduction, at least in some cases.10 Valproate can cause testicular toxicity …