Summoned before the judges in charge of the investigation in the case of the marketing of the anti-epileptic Dépakine, the National Drug Safety Agency announced on Monday that it had been indicted.
This proceeding for “negligent injury and manslaughter” is taking place in a 2016 investigation.
The National Agency for the Safety of Medicines and Health Products (ANSM) announced on Monday that it had been indicted for "injuries and manslaughter by negligence" in the case of the marketing of the anti-epileptic Depakine.
This statement follows a summons before the judges in charge of the investigation, the agency said in a press release.
The ANSM claims to take "the full measure of the suffering of the victims and has been working for several years to limit exposure to valproate in women of childbearing age".
It "will respond to any questioning of justice in order to make its full contribution to the manifestation of the truth".
An investigation opened in 2016
The investigation was opened in 2016 with the Paris judicial court, following a procedure initiated by the Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), representing 4,000 people, half of whom were sick children, and which was based on 14 cases of mothers who received Depakine during their pregnancy.
The molecule in question, sodium valproate, has been marketed since 1967 under the brand Dépakine by Sanofi, but also under generic brands, and is prescribed to people suffering from bipolar disorders.
However, it presents a high risk of birth defects in the fetus if it is taken by a pregnant woman.
The number of children disabled because of sodium valproate is estimated between 15,000 and 30,000, according to studies.
The pharmaceutical group Sanofi, accused by families of victims of having delayed too long in informing of the risks of taking this drug during pregnancy, was indicted in August for "involuntary homicides".