Donation restrictions for men taking sodium valproate

Men using the epilepsy drug sodium valproate can no longer donate sperm while they are using the drug, or for three months afterwards.

The restrictions were announced by the UK's medicine regulator the Medicines and Healthcare product Regulatory Agency (MHRA) following findings from the European Medicines Agency that five percent of children born to men taking sodium valproate had a neurodevelopmental disorder. The retrospective, observational study used data from national registries in Norway, Denmark and Sweden, but did not definitively prove that sodium valproate was the cause. All men taking sodium valproate have been warned to use contraception during and after treatment, and ensure their female partners use contraception, to reduce the potential increased risk of neurodevelopmental disorders in their children.

'This decision has been based on well–conducted research that shows that children born to men taking the antiepileptic medicine, valproate, have a slightly increased risk of developing neurodevelopmental disorders such as autism.

'It is recommended that people who take valproate should use contraception and should contact their GP or neurologist if they have any questions. It is very important though that men who are trying to have children and are currently taking valproate do not stop their medication without discussing it first with a relevant healthcare professional,' Kevin McEleny, chair of the British Fertility Society and consultant urologist at the Queen Elizabeth Hospital, Gateshead, told BioNews.

There are already warnings in place surrounding sodium valproate use during pregnancy, as the MHRA warned in 2016 that exposure in the womb increased the risk of serious developmental disorders and congenital malformation. It's been estimated that up to 40 percent of children born to mothers taking valproate during their pregnancy have developmental problems.

Restrictions introduced in January 2024 prevent anyone under the age of 55 being prescribed valproate unless medical specialists agree there is no other available and effective treatment, and two specialists must sign off on the prescription.

Claire Pelham, chief executive of the Epilepsy Society, told the BBC: 'It is right for the MHRA to be vigilant as more information becomes available about the risks of epilepsy medication; and to bring this to public attention. They have not always done so. People with epilepsy must be able to make informed choices about the drugs they wish to take'.

The MHRA have emphasised that patients should not stop taking sodium valproate without medical consultation, as this could worsen their condition.