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It is known that women who want to become pregnant must be careful with certain medications. But hardly anything is known about medication use in men who want to have children. Scandinavian research now suggests that if future fathers take Valproate, a drug for epilepsy and bipolar disorders, children may suffer neurodevelopmental disorders.
The medicine is mainly known to us as Depakine or the generic version Valproate EG. It has long been discouraged for pregnant women because it can cause fetal malformations and neurodevelopmental disorders in children. But research in Denmark, Norway and Sweden now also indicates an increased risk of neurodevelopmental disorders in children of men who use the drug in the three months before conception,” says Ann Eeckhout of the Federal Agency for Medicines and Health Products (FAGG).
This concerns developmental problems that start in early childhood, such as autism spectrum disorders, intellectual disabilities, communication disorders, attention deficit hyperactivity disorders (ADHD) and movement disorders.
“It is known that antidepressants and antihypertensives can influence sperm quality, but so far there is little or no evidence that exposure to medication in the father can cause birth defects in the fetus.”
Dirk Devrey
Professor of medicine and pharmacy (VUB)
All healthcare providers are now being informed of the new findings by the Pharmacovigilance Risk Assessment Committee (PRAC) and a clear warning will be placed on the medicine’s package leaflet as soon as possible.
The possible risk in children of men who were treated with Valproate in the three months before conception is much lower than the previously confirmed risk in children whose mothers took the drug during pregnancy. For men this concerns five children in a hundred, for women it is 30 to 40 children in a hundred.
Wake-up call
As far as we know, this is the first time that such a warning has been issued about the risks of drug use in men during pregnancies. And professor of medicine and pharmacy at the VUB Dirk Devroey is talking about a wake-up call. “Some medicines such as antidepressants and antihypertensives are known to affect sperm quality, but so far there is little or no evidence that exposure to medication in the father can cause birth defects in the fetus.”
Dr. also confirms this. Michael Ceulemans, researcher at KU Leuven and coordinator of BELpREG, the pregnancy register in Belgium. He emphasizes that the study does not provide sufficient evidence as to whether the risk of developmental disorders is actually the result of the use of Valproate by fathers. The study had some limitations, making additional research more than necessary, he says.
Questionnaire
Dr. Ceulemans emphasizes that fathers who want to have children who take Valproate cannot simply stop taking the medicine and must discuss it with their treating doctor.
At the same time, he calls on all pregnant women in Belgium to participate in BELpREG. Using questionnaires during and after pregnancy, researchers try to gather more knowledge about the safety of medication during pregnancy. “A question is also asked about the medication that male partners use in the three months prior to the start of pregnancy. Because far too little is known about this.”