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” (BMJ Group, 2024).
Yet another concern for the epileptic community. Medications that people with epilepsy take to prevent seizures and death are linked to birth defects in their children. The link has only been prominently proven for the female side of reproduction but he male side is still being researched and determined whether there is a significant link. A drug that is suppose to save the parents’ lives could now permanently affect the lives of their children.
A negative connation is connected to use of medication in this case. These anti-seizure drugs are useful for about 2/3 of the population of people with epilepsy. The rest have a drug resistant form of epilepsy and can’t control their seizures with medication. But now for the population that the drug does even work, they have new fears about the future of their children. This concern is tricky because there are two large and important outcomes. Do we risks the safety of the parents or prevent the risk being passed to the unborn children. It seems like maybe the issue is within the medication. Do we cut out the method of treatment of medication. There are other forms of treatment that do not include medication. They are advancing and building creditability. If we put the time and research and money into finding new solutions for epileptic treatment and seizure control treatment, maybe we save the parents and the children. Medication is not always the answer, it seems to be dangerous and negative when we let it answer our problems.
Reference
BMJ Group. (2024, September 20). Dad’s epilepsy med use won’t harm his kids: Study. WFMZ.com. https://www.wfmz.com/health/dads-epilepsy-med-use-wont-harm-his-kids-study/article_b4820474-6ac4-5fde-b99b-2e7537ffd2db.html