June 13, 2018.
The National Agency for the Safety of Medicines and Health Products (ANSM) has indicated that, henceforth, valproate would be prohibited for all women of childbearing age. Explanations.
A new precautionary measure
Valproate is a substance marketed in France since 1967 for the treatment of epilepsy (Dépakine, from Sanofi) and since 1977 for bipolar disorders (Dépakote and Dépamide). In pregnant women, this medicine has caused numerous physical malformations of the fetus, neurological or autistic disorders, intellectual delays or coordination difficulties.
When the link between the drug and these side effects was established, health authorities stopped prescribing this treatment to pregnant women. But this measure was not considered sufficient by the ANSM which has just demanded banning valproate for all women and adolescent girls of childbearing age, ” except in exceptional circumstances “.
Risks of fetal malformations
In a press release, the ANSM explains that valproate is ” a powerful teratogen that can cause more than 10% risk of malformations and / or neuro-developmental disorders in children exposed during pregnancy “. The drug agency would have even seized the European Medicines Agency (EMA) in order to extend ” this contraindication at European level and consider other measures “.
In total, between 2,150 and 4,100 children exposed in utero to valproate and its derivatives during the period 1967 to 2016 would have at least one major congenital malformation. A number far too large to be taken lightly by health authorities. Last April, the UK has also banned valproate for women of childbearing age unless they agree to participate in a special pregnancy prevention program.
Marine Rondot
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