INTERVIEW – The harmful effects of Depakine on the fetus have been known since the 1980s. They affect more than 12,000 people according to epidemiologist Catherine Hill.
14,322: this is the number of pregnancies exposed to Depakine between 2007 and 2014. A high number, while this antiepileptic is not recommended for pregnant women because of its teratogenic effects. And yet, 8,701 babies were born alive during this time. A report from the National Medicines Safety Agency (ANSM) estimated for the first time the extent of the phenomenon associated with sodium valproate.
The number of victims has not yet been communicated. It is the subject of a second work. The epidemiologist from the Institut Gustave-Roussy (Villejuif, Val-de-Marne) Catherine Hill, did not wait for his results.
According to its estimates, 50,000 pregnancies under Depakine, Dépakote or generics were carried out between 1983 and 2015, giving rise to 30,000 live births. 3,000 people would suffer from malformations and 12,000 from neuro-developmental disorders.
How did you get this estimate?
Catherine hill : I started with the data between 2007 and 2014 put online by the Medicines Safety Agency (ANSM). Experts concluded that 14,322 exposed pregnancies and 8,701 live births. The Directorate General of Health communicated the sales data by year from 1967 to 2015. I simply looked at the millions of boxes sold between 2007 and 2014 and extrapolated.
Everyone says that malformations occur in 10% of fetuses. So I estimated that 3,000 cases occurred during this period. Neurodevelopmental problems occur in 30 to 40% of cases. Taking the high estimate, I concluded at 12,000 victims. These figures do not add up because we do not currently know how to evaluate the associations.
Is the scale comparable to previous scandals?
Catherine hill : The problem does not lie so much in the scale: the drama remains a drama for families. But we have never quantified the impact because it is an exercise that the ANSM refuses to do. Apart from the Mediator case, this type of study is very rarely carried out. My estimate of victims of domperidone (Motilium), which put the number of annual cases at 200, was attacked by the Agency. These estimates depend on the usefulness of the treatments.
Does the effectiveness of Depakine cause reluctance?
Catherine hill : It is certainly a major element. This treatment is very effective, but you must not become pregnant with Depakine. Faced with a woman who has repeated epileptic seizures, and who only responds to Dépakine, prescribers have no choice. The logic of events must therefore be reversed. If you give this medicine to a woman of childbearing potential, you always need effective contraception, such as an IUD. The treatment should be the same as for Roaccutane.
You can’t tell when a woman is going to have a pregnancy, and a one in two chance of a deformity or neurodevelopmental disorder is unreasonable. The risk of malformation begins at the start of pregnancy, even before the woman knows she is pregnant; when she discovers the pregnancy it is already too late.
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