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According to an alert from the medicines agency, a European study suggests an increase in neurodevelopmental disorders in children whose father was treated with sodium valproate before conception. A risk that is still underestimated according to an association.
Future mothers are not the only ones who need to be careful about their treatment during or before pregnancy. According to an opinion published by the National Medicines Safety Agency (ANSM) on May 16, there is an increased risk of neurodevelopmental disorders, such as autism spectrum disorders, in children whose father has been exposed to valproate in the three months before conception. The European Medicines Agency (EMA) announces that it will continue assessing the potential risk this August.
Lower risks in the father, but present
Sodium valproate, marketed since the 1960s, is an antiepileptic drug already implicated in the significant risk of neurodevelopmental disorders when taken by the mother (one of the best-known trade names of the drug is Dépakine). The substance is also associated with a significant risk of fetal malformations.
This new study, this time focusing on fathers, indicates that in the case of taking valproate in the 3 months before conception, the risk of neurodevelopmental disorders in the child varies between 5.6% and 6.3 %.
In comparison, the risk is “2.5% to 3.6% for children born to fathers treated with lamotrigine or levetiracetam”, the two other medications prescribed for epilepsy analyzed in the study. However, other studies are being undertaken before arriving at new safety measures. A European evaluation is underway.
An “underestimated” rate fears an association
If the announcement of this risk coming from the father is an important step, it does not completely convince the associations concerned. Marine Martin, president and founder of Apesac (an association helping parents of children suffering from anti-convulsant syndrome) spoke on August 4 on France Info that the risk of malformations and neurodevelopmental disorders was “under- estimated.”
“The laboratories which produce Dépakine find themselves once again judge and party”, she reproaches. Martin, who nevertheless conceded “that the Medicines Agency does not have the financial means to commission such a study”. But according to her, the “precautions” taken by the National Medicines Safety Agency (ANSM) show that there are already “a certainty that this risk is underestimated”.
Greater precautions requested by the ANSM
The day before, in fact, the National Medicines Safety Agency published an update concerning its European evaluation and requested new directives.
“Pending the conclusions of this evaluation, we are sending an information letter to all healthcare professionals concerned to alert them to this potential risk.” An information sheet on the risks involved must therefore be given to patients when prescribing or dispensing a specialty based on valproate or one of its derivatives.
The ANSM also adds that it has asked the laboratories marketing these drugs to submit to them “a request to modify their marketing authorizations so that this potential risk appears in the summary of product characteristics and in the instructions for these medicinal products.”
The matter is taken seriously.
Treatment should not be stopped suddenly
The Epilepsie-France association reacted to this opinion. Although these results raise “many legitimate concerns from patients” she indicates, the association, like the ANSM, however, reminds that we do not modify a treatment for epilepsy without medical advice.
“If you are a man taking a medicine containing valproate or one of its derivatives, do not stop your treatment without talking to your doctor. Stopping treatment exposes epileptic patients to the recurrence of seizures”
For its part, the association adds : “Moderation is recommended at this stage in order to avoid any initiative by patients detrimental to their health”.
Each epilepsy being unique, “It is imperative for patients treated with Valproate to contact their doctor and not to stop treatment without the medical advice of their neurologist or, failing that, their treating physician.” concludes France Epilepsie.