Harm not found in review of anti-seizure medication used by fathers

No clear evidence has been found of increased risk of neurodevelopmental disorders in children born to men taking anti-seizure medication, in a systemic review.

Earlier this month the UK's Medicine and Healthcare products Regulatory Agency (MHRA) warned men taking sodium valproate, an epilepsy drug, to use appropriate contraception following findings of an increased risk of neurodevelopmental disorders such as autism and ADHD in their children (see BioNews 1256). Restrictions have also been put in place for sperm donors. Researchers from the University of Melbourne, Australia, have since published a systematic review in the Journal of Neurology, Neurosurgery and Psychiatry looking at ten studies. While there was limited evidence available, they found that there was no clear evidence for increased risks in offspring.

Dr Bassel Wattar, associate professor of reproductive medicine and medical director of the Clinical Trials Unit at Anglia Ruskin University, Chelmsford, commented: 'The conclusion is slightly exaggerated, giving a sense of reassurance, while in fact, the studies' summaries are simply not reporting harm. Therefore, caution is warranted when interpreting the findings of this review… Couples with epilepsy (maternal or paternal) require additional fertility support and detailed pre-conception counselling to help them achieve a healthy pregnancy. The results of this research are helpful to inform preconception care counselling'.

Warnings were handed out to male patients and sperm donors after an observational cohort study using data from Scandinavian countries by the European Medicines Agency showed an increased risk of autism in children born to men using sodium valproate around the time of conception. That study was commissioned due to the discovery that sodium valproate use in pregnancy was responsible for children being born with birth defects and disabilities, including neurological conditions, leading to restrictions on its use in women across Europe.

Authors of the latest systemic review highlight the risks associated with restricting access to sodium valproate, and specifically criticise the measures taken by the MHRA in the UK. They do however, say the issue is under-researched and there needs to be more investigation in the area.

Experts discussing the review have highlighted that while reassuring, the review doesn't highlight the actual number of father-offspring pairs analysed in the studies, and how reliable these studies were.

The risks of sodium valproate medications for women during pregnancy are better understood. This month, a French court ordered Sanofi to pay reparations of €285,000 (£235,000) to a mother whose pregnancies, which occurred while she was taking Depakine, the company's sodium valproate drug, resulted in birth defects. The pregnancies occurred between 1998 and 2002.