2023-12-12 08:30:00
Several antiepileptic drugs have been singled out in recent years for their teratogenic effects. Among them, valproate and its derivatives, now contraindicated during pregnancy and to be avoided in women of childbearing age. But what happens when the father-to-be takes one of these treatments at the time of conception? Should he also stop his treatment? Are there any consequences to be feared for the future child? Health On the Net provides you with answers to these questions.
Valproate and derivatives prohibited during pregnancy
Valproic acid or valproate is a medicine used in the treatment of epilepsy. In parallel, sodium divalproate and valpromide are prescribed for the treatment of bipolar disorder. All of these drugs are metabolized in the human body to valproic acid. However, several studies have shown the existence of teratogenic effects with these drugs. Valproate is revealed a powerful teratogenresponsible :
- Congenital malformations (in more than 10% of children exposed in utero) ;
- Neurodevelopmental disorders (in 30 to 40% of children exposed in utero).
In France, valproate and its derivatives are contraindicated in pregnant women, but also in women of childbearing age without contraception effective since July 2017. Since June 2018, this decision has been ratified at European level. These medications are now prohibited during pregnancy and should no longer be prescribed to women of childbearing age. These prohibitions and contraindications even appear on the packaging of medicines with a pictogram and a statement “VALPROATE + PREGNANCY = PROHIBITED”.
What if the father-to-be takes valproate?
Some women can nevertheless be treated with one of these medications, when no other therapeutic alternative is possible: other treatments are ineffective or not tolerated. Indeed, epilepsy itself can have consequences on the course of the pregnancy. For these women, several conditions must be met before they can undergo treatment with valproate:
- Complete information on the risks associated with taking these medications;
- An annual reassessment of the benefit of the treatment;
- Taking effective contraception: implant or intrauterine device or combination of oral contraception with wearing a male condom;
- Carrying out pregnancy tests before delivering treatments;
- The annual signing of a care agreement with the specialist doctor.
If everything seems to be done to avoid the exposure of a fetus to the effects of valproate and its derivatives through maternal exposure, what regarding paternal exposure? Studies carried out in animals and humans have shown that valproate and its derivatives might impair male fertilityin particular the number and quality of sperm, erectile function, secretion of sex hormones or testicular volume.
No sperm donation until three months following stopping
Beyond these effects which can harm the couple’s conception project, have any effects on the fetus been observed when the father is treated with one of the valproate derivatives? The passage of valproic acid into the seminal fluid is very low. Studies carried out to date have not shown no effect on congenital malformations in children whose father was treated with these drugs during the trimester before conception or at the time of conception.
On the other hand, the ANSM recently relayed the results of a study suggesting that children born to a father treated with valproate in the 3 months preceding pregnancy might present increased risk of neurodevelopmental disorders. Pending additional data, the ANSM invites the men concerned to contact their specialist to consider a therapeutic alternative before considering a parental plan. In any case, no treatment should be stopped without medical advice. The ANSM also asks men taking valproate to do not donate sperm during treatment and for three months following stopping treatment.
Estelle B., Doctor of Pharmacy
Sources
– Valproic acid – Pregnancy and breastfeeding. www.le-crat.fr. Accessed November 29, 2023.
– Valproic acid – paternal exposure. www.le-crat.fr. Accessed November 29, 2023.
– Valproate and derivatives: potential risk of neurodevelopmental disorders in children whose father was treated in the 3 months preceding conception. ansm.sante.fr. Accessed November 29, 2023.
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