Systematic Review Highlights No Major Risks to Offspring from Would-be-Fathers Taking Epilepsy Medications
Would-be dads taking drugs to stop their epilepsy seizures and valproate in particular should be largely reassured that the available evidence on the developmental risks to their offspring doesn’t justify any major concerns, concludes a systematic review of relevant studies published online in the Journal of Neurology Neurosurgery & Psychiatry.
The authors trawled research databases that reported on neurodevelopmental disorders, major congenital abnormalities, low birthweight or smaller than expected size at birth, among the babies of fathers taking antiseizure drugs when the child was conceived.
This showed that although the data were limited, there was no clear evidence of a detrimental impact of these drugs on the studied outcomes in men taking them. A few isolated harmful side effects weren’t replicated in other investigations.
The European drugs regulator, the EMA, commissioned a retrospective observational study drawing on Scandinavian registry data. Yet to be peer-reviewed, this suggests that there may be an estimated 5% increased risk of neurodevelopmental disorders in children born to men taking valproate in the 3 months before conception compared with around 3% for two other antiseizure drugs lamotrigine and levetiracetam.
The EMA, however, concluded that it wasn’t possible to establish whether the increased risks were due to valproate, because of various important methodological limitations.
And in January 2024 it recommended that valproate could be prescribed for men with epilepsy, bipolar disorder, or migraine, provided treatment is supervised and patients are advised of the possible risks and use contraception. And it recommended regular reviews to assess the suitability of the treatment when planning to father a child.
But the UK drugs regulator, the MHRA, took a more restrictive stance, prohibiting starting anyone under the age of 55 on valproate unless there was no other effective and well tolerated alternative or where there was absolutely no possibility of new parenthood.
And this month, the MHRA updated its safety guidance for men, advising that they should be aware of the potentially increased risk and should use contraception while taking the drug and for 3 months after stopping treatment.
“The wisdom of the UK regulatory changes has been questioned,” point out the review authors, adding that not prescribing valproate “is likely to lead to an increased risk of morbidity and mortality, including an increased risk of sudden unexpected death in epilepsy (SUDEP).”
They acknowledge that the quality of the studies included in their review was variable and that the potential reproductive implications of taking antiseizure drugs in men have not been sufficiently studied. This clearly needs to be addressed, they emphasise.
But they suggest: “In view of the findings of this systematic review, particularly the reassuring results from the recent large population-based study from Denmark, the MHRA restrictions regarding the use of valproate in men should be reappraised and potentially revised.”
Reference: ‘Paternal exposure to antiseizure medications and offspring outcomes: a systematic review’ by Eliza Honybun et al. was published in The Journal of Neurology Neurosurgery and Psychiatry at 23:30 hours UK time (BST) Tuesday 17 September 2024. 10.1136/jnnp-2024-334077
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