A study published by the French Medicines Agency (ANSM) shows that the number of pregnant women exposed to depakine and other valproate-based medicines has decreased significantly since 2013. However, it remains too high, in particular for bipolar patients, according to the agency.
Between 2013 and 2018, "the number of pregnancies exposed to valproate decreased by almost 80%", going from 1,044 pregnancies to 224, according to new monitoring data presented on Tuesday. These pregnancies gave rise to 124 births, against 692 five years earlier, down 82%, according to this monitoring carried out by Epi-flagship, a structure of public expertise bringing together the Medicines Agency and Health Insurance.
Heavy consequences for the child
"We keep the objective of reducing the proportion of women exposed," assured AFP Philippe Vella, director of drugs in neurology at the ANSM. Sodium valproate, marketed by Sanofi under the brands Dépakine, Dépakote and Dépamide, as well as under generic brands, is prescribed for patients with epilepsy and suffering from bipolar disorder.
But if it is taken by a pregnant woman, her child presents a risk of approximately 10% of congenital malformations and an estimated risk between 30% and 40% of developmental delay (autism spectrum disorders, delay in walking or language…).
Alternatives for bipolar women
After initial reinforcement of the warnings on these risks in 2013, the conditions of prescription and delivery to women of reproductive age were gradually made stricter from 2015 and several devices were put in place to ensure that women are aware of the risks.
Today, it is formally contraindicated in pregnant women for bipolar disorder. In women of reproductive age and in pregnant epileptic patients, it should only be prescribed in the absence of a therapeutic alternative (ineffectiveness or poor tolerance of other treatments). "Continuing to have bipolar pregnant women exposed is a situation that must be reduced to almost zero, since it is contraindicated and there are alternatives," said Dr. Vella.
Many parents of children who are victims of valproate, grouped together in the Apesac association, criticize the Sanofi laboratory and the health authorities for taking too long to correctly inform the risks of this medication for women of reproductive age, even though they were described since the 1980s. Sanofi announced Monday evening its indictment for "aggravated deception" and "involuntary injuries" in the criminal section of this case.
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