The case of the Dépakine has done damage: more than 30 000 children, exposed in the womb of the mother to this drug prescribed against epilepsy, are suffering from neuro-developmental disorders. Actions have since been put in place and raising awareness among health professionals seems to be paying off.
In 2016, the Chained Duck revealed "an alarming study on the Dépakine carefully hidden to families" ... followed a health scandal.
Proven risks for the baby
Since then, the dangerousness of this drug to treat epilepsy, has been confirmed, especially on the development of the fetus, when it is prescribed to women during pregnancy.
The risks of early neurodevelopmental disorders in children have also been denounced and are now confirmed. Involved, valproic acid, which is the substance contained in Dépakine, marketed by Sanofi and other laboratories, which would have a harmful effect on the cells and modify the expression of certain genes.
This is confirmed by a study conducted by theNational Agency for the Safety of Medicines (ANSM) and the National Fund for Health Insurance. The work involved more than 1.7 million children, all born between 2011 and 2014, "without diagnosis of brain malformation at birth". They were followed for at least 3 years to assess the risk of early neurodevelopmental disorders.
Result, a child whose mother has taken a treatment that contains valproic acid, presents "4 to 5 times more risk" than a child whose mother would not have received this type of antiepileptic during her pregnancy. In children exposed to even higher doses, the risks are "8 to 10 times higher".
Action plans put in place to limit exposure to this substance
TheANSM recalls in its communiqué that "several risk reduction measures to limit exposure to valproate during pregnancy have been implemented since 2015 by the health authorities in connection with the APESAC patient association and health professionals. "
The implementation of these actions has helped to reduce45% the number of women of childbearing age on valproate and 66% the number of children born of pregnancies exposed to valproate ", according to figures released by the National Health Data System.