“Children exposed during pregnancy to drugs based on valproate or its derivatives (Dépakine®, Dépakote®, Dépamide®, Micropakine® and generics) have a high risk of birth defects as well as an increased risk of serious developmental disorders. In view of these risks, the prescription and dispensing of these drugs for girls, adolescents, women of childbearing age and pregnant women have been restricted in France.“has just announced the National Agency for Medicines and Health Products Safety (ANSM).
Henceforth, the initial prescription of this anti-epileptic is therefore reserved for specialists in neurology, psychiatry or pediatrics, while requiring the collection of a care agreement after complete information to the patient. But the renewal of the prescription during the year remains possible by any doctor.
A risk of congenital malformation of 10.73%
As the ANSM underlines in a guide intended for prescribing physicians, studies carried out in children exposed in utero to drugs based on valproate have shown that the risk of congenital malformations is on average 10.73%, i.e. a risk much higher than that of the general population, which is 2% to 3%.
In addition, the intelligence quotient (IQ) measured in school-aged children (6 years) exposed in utero to valproate is on average 7 to 10 points lower than that of children exposed to other antiepileptics.
Finally, the available data show that these children have an increased risk of presenting pervasive developmental disorders (syndromes belonging to the autism spectrum) (approximately 3 times more common) and childhood autism (approximately 5 times more common), compared to that of the control populations.
In these new recommendations, the ANSM therefore recalls that valproate should not be prescribed to girls, adolescents, women of childbearing age and pregnant women, except in cases of ineffectiveness or intolerance to all other drug alternatives.
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Dépakine: more than 14,000 pregnant women exposed
Congenital malformation: the pollution involved
Pollution doubles the risk of autism
