The anti-epileptic Depakine marketed in France by Sanofi since 1967 would be the cause of congenital malformations of the fetus in several pregnant women.
The pharmaceutical group Sanofi has announced its indictment for “aggravated deception” and “unintentional injuries” following the marketing of the antiepileptic Depakinea medicine containing sodium valproate, a substance that can cause birth defects to the fetus if ingested during pregnancy.
Between 16,000 and 30,000 children affected
In a report dated February 2015, the General Inspectorate of Social Affairs (IGAS) estimated that the pharmaceutical group and the Medicines Agency (ANSM) had shown “low responsiveness”, in particular by not having fairly communicated on the risks incurred by pregnant women treated with this drug. A preliminary investigation carried out in 2018 by the ANSM and the Health Insurance (CNAM), confirmed that the children exposed in utero to this molecule were in fact four to five times more likely to suffer from mental and behavioral disorders: 16,000 to 30,000 children would be affected.
A procedure was therefore launched in 2016 at the initiative of Association to help parents of children suffering from anticonvulsant syndrome (APESAC), which “deals with poisoning of the fetus with anticonvulsants or mood stabilizers, prescribed to the mother during pregnancy, for epilepsy or bipolar disorders”. Apesac brings together 4,000 people, half of whom have sick children.
“Sanofi braces itself on a position of denial”
The investigation opened the same year aimed to establish whether there had been “deception on the risks inherent in the use of the product and the precautions to be taken which had the consequence of making its use dangerous for human health. ” between 1990 and April 2015.
“It is a reversal of the file, which so far has not made much progress, declared to AFP Mand Charles Joseph-Oudin, the lawyer for Apesac. Sanofi is bracing itself on a position of denial of responsibility which is more and more difficult to maintain”. About 40 people have filed a criminal complaint “of extreme gravity and which actually concerns thousands of victims”, he added. On his side, Sanofi has indicated that this indictment would allow it “to assert all its means of defense and will be the opportunity to demonstrate that it has complied with its obligation to inform and has demonstrated transparency”.
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