Children whose fathers were treated with sodium valproate or its derivatives (Depakene, Depakote, Depamide, Micropakine, and generics) in the three months before conception have “an increased risk of neurodevelopmental disorders compared to fathers who were treated with other antiepileptic drugs (lamotrigine or levetiracetam),” according to a press release issued by the French National Agency for the Safety of Medicines and Health Products (ANSM).
Epilepsy
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A 6% risk if the father was taking Depakene.
Depakene is prescribed to patients with epilepsy and bipolar disorder. It is currently contraindicated in pregnant women and women of childbearing age. A study published in the journal Scientific Reports in 2020 showed that pregnant women taking the drug had a fivefold increased risk of their children suffering developmental disorders.
The ANSM is now sounding the alarm: if fathers were taking Depakine, there may be consequences for their children. In its press release, ANSM refers to a study in which researchers compared children whose fathers were treated with sodium valproate (including Depakene) three months before conception with children whose fathers were treated with lamotrigine or levetiracetam. Results: those treated with sodium valproate have a 6% risk, while those treated with lamotrigine or levetiracetam have only a 3% risk.
Do not stop taking Depakine without consulting your doctor.
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This study has limitations that do not allow definitive conclusions to be drawn at this stage, says ANSM. The European Medicines Agency (EMA) has therefore asked the laboratories to carry out additional analyses to assess the reliability of the data.
By issuing this press release to healthcare professionals, ANSM is applying the precautionary principle to encourage doctors to consider other treatments for their patients. “Discuss the possibility of therapeutic alternatives with those planning to conceive a child,” the health body states.
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On the other hand, in an information sheet for patients, the ANSM advises them not to discontinue treatment without consulting a doctor, as this could expose them to a recurrence of symptoms.
References
Coste, J., Blotiere, PO., Miranda, S. et al. Risk of early neurodevelopmental disorders associated with in utero exposure to valproate and other antiepileptic drugs: a nationwide cohort study in France. Sci Rep 10, 17362 (2020). https://doi.org/10.1038/s41598-020-74409-x
ANSM. (2023). Valproate et dérivés : risque potentiel de troubles neurodéveloppementaux chez les enfants dont le père a été traité dans les 3 mois qui précèdent la conception. ANSM: Agence nationale de sécurité du médicament et des produits de santé. https://ansm.sante.fr/informations-de-securite/valproate-et-derives-risque-potentiel-de-troubles-neurodeveloppementaux-chez-les-enfants-dont-le-pere-a-ete-traite-dans-les-3-mois-qui-precedent-la-conception
