At least 370 cases of birth defects in France. This is the assessment of the taking of an antiepileptic based on valproate (Dépakine®, Dépakote®, Dépamide®, Micropakine® and generics) by pregnant women, according to the socialist deputy specialist in health issues, Gérard Bapt. An inexcusable health situation that highlights the dysfunctions of health organizations.
“This health drama reveals the major dysfunctions of the European drug monitoring bodies,” said the MP in a press release.
Indeed, the side effects of this molecule (risk of malformation on the foetus) have been known for many years.
In 1982, the medical journal The Lancet reported the side effects of this drug during pregnancy. In 2006, the Vidal, the reference work of French health professionals, advised against the use of this antiepileptic for pregnant women.
The French Medicines Agency (ANSM) is waiting for June 2015 to tighten the prescription conditions for this family of medicines and announces that “given these risks, the prescription and delivery of these medicines for girls, adolescents, women of to procreate and pregnant women have been restricted in France”. “From now on, the initial prescription of this antiepileptic is therefore reserved for specialists in neurology, psychiatry or paediatrics, while imposing the collection of a care agreement after complete information of the patient”.
The official figures
In June 2015, the official figures come out and the ANSM publishes a guide for prescribing doctors.
Antiepileptics based on valproate (Dépakine®, Dépakote®, Dépamide®, Micropakine® and generics) are said to have caused 377 malformations in France between 1986 and 2015 as well as 54 miscarriages, abortions or deaths of young babies, according to figures from the ANSM. The risk of congenital malformation of the fetus in a woman who takes valproate is on average 10.73% compared to 2 to 3% for the general population. Up to 30-40% of children exposed in utero to these products show developmental delays in early childhood and are about three times more likely to suffer from autism-like disorders, according to this publication.
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