Depakine: the Sanofi laboratory condemned for lack of information on the leaflet

Depakine the Sanofi laboratory condemned for lack of information on

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    The French group Sanofi was ordered by the court of Nanterre to compensate a family, whose daughter exposed to Dépakine in utero was born with serious malformations.

    This is a great first in an individual judicial file. The pharmaceutical laboratory Sanofi was ordered by the court of Nanterre to compensate up to 450,000 euros a family whose daughter, exposed to Depakine in utero, was born in 2005 with malformations. She also suffers today from a significant psychomotor retardation.

    Depakine: serious side effects

    Since 2003, Sanofi “knew” that taking Depakine could lead to neurodevelopmental risks in fetuses.

    However, it will be necessary to wait until 2006 for the laboratory to advise against taking this drug “during pregnancy” and “recommends the rapid consultation of a doctor in the event of discovery of such a state”.

    Negligence with tragic consequences for some families. This is the case of this mother – uninformed of the risks – who continued to take Depakine while pregnant in 2005 to treat her epileptic seizures.

    Result: his daughter, exposed to sodium valproate (active ingredient of Depakine) was born with malformations, then suffered, during her childhood, from delays in psychomotor development and global acquisitions.

    Sodium valproate: Sanofi would have hidden the side effects from the public

    In 2014, the family decided to sue the laboratory. The reason is clear: Sanofi would have hidden the side effects of the drug from the public (lack of closure of the spine, cardiovascular abnormalities, language delay, autism spectrum disorders, etc.).

    The Nanterre court condemned the laboratory. According to him, the band should have mentioned – as soon as they found out – “the risk of autistic disorders incurred“in the drug package insert.

    This decision condemning the laboratory marks a turning point for the individual recognition of each of the children exposed to Depakine“, revealed the family’s lawyer, Mr Charles Joseph-Oudin, calling on the group to “change behavior in all procedures”.

    While the number of disabled children due to sodium valproate is estimated at between 15,000 and 30,000, Sanofi has decided to appeal following this first court decision.

    In all, the court is seized of 23 civil cases, including one involving 272 plaintiffs. Four other cases of children born in 1989, 2005 and 2006 went to trial on Thursday. For the time being, few families who are victims of Dépakine have been compensated in this way.

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