A few days ago, a deputy alerted the health authorities to the number of malformations occurring in babies whose mothers were taking anti-epileptic drugs based on valproate (Dépakine®, Dépakote®, Dépamide®, Micropakine® and generics). These drugs would have caused in France 377 malformations between 1986 and 2015as well as 54 miscarriages, abortions or infant deaths.
According to one information from the Figaro, the Minister of Social Affairs and Health, Marisol Touraine asked the General Inspectorate of Social Affairs (Igas) to open an investigation concerning this epileptic, “in order to analyze the decision-making mechanisms taking into account the evolution of scientific knowledge, elements from pharmacovigilance, decisions made in other countries, particularly in Europe, and the conditions of use of this medicinal product”.
The Minister of Health also asked the Medicines Agency (ANSM) and the National Health Insurance Fund to identify children exposed in utero to sodium valproate and suffering from malformations or suffering from neurobehavioral disorders. .
As the ANSM points out in a guide for prescribing physicians, studies carried out in children exposed in utero to valproate-based drugs 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 children of school age (6 years) exposed in utero to valproate is on average 7 to 10 points lower than that of children exposed to other antiepileptics.
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