The National Medicines Safety Agency (ANSM) has hammered it December 2 last: the valproat and its derivatives (Dépakine®, Dépakote®, Dépamide®, Micropakine® and generics), used to treat epilepsy or bipolar disorders, expose to a risk of malformation of the fetus and should no longer be prescribed in pregnant or pregnant women. age to conceive.
80,000 people in France treated with Dépakine
Since then, the Haute Autorité de Santé (HAS) published on December 9, in conjunction with the ANSM, a memo sheet for prescribing physicians. This short guide sets out the recommendations for alternative therapeutic management to valproat in patients with epilepsy or bipolar disorder.
However, this specialty, which has demonstrated its effectiveness, is still on sale because it is considered essential for certain patients. The prescription of the drug is in fact authorized in the event of inefficiency or intolerance to therapeutic alternatives. 80,000 people in France are treated each year with this molecule.
Depakine: 377 malformations between 1986 and 2015
According to an ANSM survey, 62% of women treated with Dépakine are not informed or poorly informed about the adverse effects of the specialty and 94% have not signed a care agreement form, compulsory in theory before any prescription.
Still according to the Medicines Agency, these antiepileptics would have caused 377 malformations in France between 1986 and 2015 and 54 miscarriages, abortions or infant deaths. The risk of congenital malformation of the fetus in a woman on valproate is 10.73% compared to 2 to 3% for the general population.
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