A large Taiwanese study has found no association between fathers taking the antiseizure medication valproate before conception and an increased risk of neurodevelopmental disorders or birth defects in their children.
The findings, published in Neurology, add to evidence about the potential reproductive effects of antiseizure medicines in men. Valproate is already known to carry significant risks during pregnancy when taken by the mother, including birth defects and developmental problems, but much less is known about paternal exposure.
Researchers analysed health records for 2,583,503 children born in Taiwan over a 15-year period. Of these, 1,701 had fathers who had been prescribed valproate during the three months before conception, corresponding to the period of sperm development.
After accounting for factors including parental age, the child’s sex, birth weight, pregnancy complications and maternal medical history, the researchers found no significant association between paternal valproate exposure and autism, ADHD, tic disorders, intellectual disability or birth malformations.
A sibling analysis provided further reassurance. Researchers compared children whose fathers had taken valproate before conception with their siblings whose fathers had not taken the medication during the corresponding period. Again, no significant increase in neurodevelopmental disorders or birth defects was identified.
The study also found no increased risk associated with several other commonly prescribed antiseizure medicines.
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The findings are particularly relevant because concerns about paternal valproate exposure have led to changes in prescribing advice in some countries, including the UK. However, the researchers stressed that the results do not establish that valproate is completely risk-free for prospective fathers.
One limitation was that some children had only five years of follow-up, meaning some neurodevelopmental diagnoses may not yet have been recorded. The researchers said longer-term studies are needed before conclusions about prescribing recommendations can be changed.
The study therefore provides reassuring evidence for men with epilepsy who require valproate, while highlighting the need for continued research into paternal exposure to antiseizure medicines.
This news item has been summarised using AI and checked by humans before publication.
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