“Valproate (Dépakine) is now prohibited during pregnancy and should no longer be prescribed to women or adolescent girls of childbearing age,” ANSM said on Tuesday, June 12. Here’s why.
“Valproate is banned during pregnancy and should no longer be prescribed to girls, adolescents and women of childbearing age,” said Tuesday evening June 12 ANSM. The European Commission has just endorsed this contraindication.
The contraindication was associated with the introduction of a new pictogram (prohibition) on the box and on the blisters of these specialties, accompanied by a warning “VALPROATE + PREGNANCY = PROHIBITED. Do not use in women of childbearing potential without effective contraception, or pregnant “. Valproate, better known as depakine, is a treatment for epilepsy and manic episodes in bipolar disorder. It causes a high rate of malformations (more than 10%) and / or neurodevelopmental disorders (30 – 40%) in children exposed during pregnancy.
Significantly reduced academic performance
Between 2,150 and 4,100 children who were exposed in utero to valproate and its derivatives during the period 1967-2016 would have at least one major congenital malformation, according to an estimate for France established by a study by health authorities published in 2017. Children born to mothers who took the epilepsy drug during their pregnancy also have significantly decreased academic performance in elementary and middle school, according to the report. a whole new research from Aarhus University, Denmark. “However, some pregnant women cannot avoid epileptic seizures if they do not take Valproate”, shades Jakob Christensen, author of the research. “It may therefore be necessary to treat women with epilepsy with Valproate during pregnancy, even though there are risks.”
Exceptional situations of resistant epilepsy
In this perspective, the ANSM specifies that it is absolutely necessary to avoid prescribing Valporate in pregnant women and in those planning to become pregnant, except in exceptional situations of epilepsy resistant to other treatments.
Women with epilepsy should make sure they do not have a seizure when they become pregnant. The developing baby is at some subsequent risk of direct trauma to the mother’s abdomen during a violent seizure. There is also the risk of a major seizure which temporarily deprives him of oxygen. Mum falls are also possible.
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