Dépakine scandal: the French Medicines Agency indicted
Dépakine has been marketed by Sanofi since 1967. BSIP / UIG via Getty Images
Text by: RFI Follow
2 min
The National Agency for Medicines and Health Products Safety (ANSM) announced on Monday, November 9 that it had been indicted for "injuries and involuntary manslaughter by negligence" in the case of the marketing of the anti-epileptic Depakine .
Publicity
Read more
The ANSM's announcement regarding his indictment 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 and complete contribution to the manifestation of the truth
".
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 about the risks of taking this drug during pregnancy, had been indicted in August for “involuntary homicides”.
(With
AFP
)
Newsletter
Receive all the international news directly in your mailbox
I subscribe
Follow all the international news by downloading the RFI application
google-play-badge_FR
France
Justice
Health and medicine