2023-08-04 09:34:21
August 04, 2023
The National Medicines Agency on Thursday called on caregivers and patients to be vigilant regarding sodium valproate, the active ingredient of antiepileptic drugs including Depakine. Children of exposed fathers may be at higher risk for neurodevelopmental disorders.
The ANSM alerted health professionals and patients on Thursday August 3. According to her, there is a “Potential risk of neurodevelopmental disorders in children whose father took valproate or one of its derivatives in the three months preceding conception”. Sodium valproate is an antiepileptic drug notably marketed under the name Depakine by the Sanofi laboratory.
The ANSM relies on a study commissioned by its European counterpart, the EMA, the results of which it had already made public in May. This work was carried out on the basis of health data in Norway, Sweden and Denmark. Children whose fathers were treated with sodium valproate within three months before conception were compared with children whose fathers were treated with lamotrigine or levetiracetam, two other antiepileptics.
The precautionary principle
The first group of children would be more at risk of neurodevelopmental disorders such as autism spectrum disorders. “This risk varies between 5.6% and 6.3% in children born to fathers exposed to valproate compared to 2.5% and 3.6% for children born to fathers treated with lamotrigine or levetiracetam “, specifies the ANSM.
The Medicines Agency, however, believes that “The limitations of this study do not allow us to conclude on this risk at this stage”. The EMA has already requested additional data from the laboratories concerned in order to rule definitively on this risk. The ANSM also wants manufacturers to include this possible risk in the summaries of drug characteristics and leaflets.
Sodium valproate has been at the heart of a vast health scandal for several years. It is known to be responsible for cognitive deficits and autism spectrum disorders in 30 to 40% of children whose mothers have been treated with valproate. And, since the marketing of Depakine in 1967, between 2,150 and 4,100 children exposed in utero have suffered from at least one major malformation according to ANSM and Health Insurance estimates made public in 2017.
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Source : ANSM August 3, 2023, ANSM and Health Insurance April 20, 2017
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Written by : Dorothée Duchemin – Edited by Emmanuel Ducreuzet
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