Babies whose father took the drug called “Depakine” during the three months preceding conception would be at risk of developing neurodevelopmental disorders.
- Children whose father took Depakine in the three months before conception have a higher risk of neurodevelopmental disorders.
- This risk is 6% against 3% in children whose father took other antiepileptics.
- The ANSM recalls that treatment should not be stopped without medical advice, even if men are trying to have a child.
There would be “an increased risk of neurodevelopmental disorders in children whose fathers were treated with valproate or its derivatives (Depakine, Depakote, Depamide, Micropakine and generics) within three months before conception, compared to fathers treated with other antiepileptics (lamotrigine or levetiracetam)can we read in a press release published by the National Agency for the Safety of Medicines and Health Products (ANSM).
6% risk of disorders if the father took depakine
Depakine is a drug produced by Sanofi. This is prescribed for epileptic and bipolar patients. Currently, it is contraindicated for pregnant women and those of childbearing age, according to the Vidal. A study published in 2020 in the journal Scientific Reports showed that taking this drug by pregnant women increased the risk by five that the baby would suffer from developmental disorders.
From now on, the ANSM is sounding the alert: if the dads have taken Depakine, this can also have consequences for the children. In this press release, the ANSM relies on a study where the scientists compared children whose father was treated with valproate (including Depakine) in the three months preceding conception, compared to children whose father was treated with lamotrigine or levetiracetam. Results: the risk is 6% for the first against 3% for the others.
Do not stop Depakine without medical advice
“This study has limitations that do not allow definitive conclusions to be drawn at this stage. specifies the ANSM. The European Medicines Agency (EMA) therefore asked the laboratories for additional analyzes to assess the robustness of these data.”
By publishing this press release intended for healthcare professionals, the ANSM is applying the precautionary principle so that practitioners consider other treatments for their patients. “For those planning to conceive, discuss with them the possibility of treatment alternatives”, indicates the health instance.
On the other hand, in the patient information sheetthe ANSM advises them not to stop their treatment without talking to their doctor, as this could expose them to the reappearance of symptoms.
