FRIDAY, Sept. 20, 2024 (HealthDay News) — Would-be dads don’t have to worry that taking the epilepsy drug valproate will result in children with birth defects, a new review concludes.
Valproate, an anti-seizure drug, is known to cause birth defects and developmental disorders when taken by pregnant women.
But the drug does not appear to have the same impact on the fetus when taken by men hoping to become fathers, researchers report.
“Our systematic review shows that evidence for any risk to the offspring resulting from paternal exposure to anti-seizure medications is scarce and inconsistent, with most studies showing no increased risk compared with unexposed controls,” wrote the research team led by co-senior author Piero Perucca, a professor of adult epilepsy with the University of Melbourne in Australia.
“Therefore, the available evidence does not justify major concerns,” the team concluded.
Experimental animal studies have linked anti-seizure drugs to male infertility, birth defects and developmental delays, sparking concerns that human males might run the same risks.
In fact, one major government regulatory body — the U.K.’s Medicines and Healthcare Products Regulatory Agency — has gone so far as to prohibit valproate use for anyone under the age of 55 who might become a new parent.
For the new review, researchers pooled data on 10 studies evaluating the effects on pregnancy of valproate taken by men.
Although the data were limited, researchers found no clear and consistent evidence of harm caused by fathers-to-be taking valproate.
“The wisdom of the U.K. regulatory changes has been questioned, because restricting the use of valproate could result in prescription of a less effective medication, particularly in individuals with generalized epilepsies where valproate is the most effective [anti-seizure medication],” the researchers noted.
The team added that not prescribing valproate to men is likely to lead to an increased risk of disease and death, “including an increased risk of sudden unexpected death in epilepsy (SUDEP).”
However, the researchers also noted that more research is needed.
“While the findings summarized in our systematic review are overall reassuring for males taking anti-seizure medications including valproate, it is clear that the potential reproductive implications of anti-seizure medication exposure in males remain an under-investigated area of research that should be prioritized over the next decade,” the researchers concluded.
The evidence review was published Sept. 19 in the Journal of Neurology Neurosurgery & Psychiatry.
In an editorial published alongside the study, Torbjorn Tomson, with the Karolinska Institute, agreed that the pooled evidence “provides essential comprehensive, and mainly reassuring, information indicating no increased risks for developmental disorders with paternal valproate exposure.”
“It is questionable to refer to the [U.K.’s] restriction as a precautionary measure when they place male patients with generalized epilepsies at risk of inadequate seizure control with potentially fatal consequences,” Tomson, a professor of clinical neuroscience, concluded in a journal news release. “Potential risks with paternal exposure will remain a hot topic, but it is difficult to see how more conclusive evidence regarding valproate could be generated within the next few years.”
More information
The National Institutes of Health has more on valproate and pregnant women.
SOURCE: BMJ Group, news release, Sept. 17, 2024
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