Dépakine: Sanofi found responsible for a lack of vigilance and information on the risks of the drug



The Sanofi laboratory pinned down. The pharmaceutical giant was held responsible, Wednesday, January 5, by the Paris court of law, for a lack of vigilance and information on the risks that Depakine presents for the fetus if taken during pregnancy.

In addition, the Paris court ruled “Admissible” the group action presented by the Association of victims of Depakine against the laboratory, paving the way for a judicial first in France in the field of health.

→ ANALYSIS. La Dépakine, the legal bullet of Sanofi

This procedure was launched in May 2017 at the initiative of the Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), which considers that Sanofi took too long to inform patients of the risks. malformation or developmental delay in children whose mothers received this treatment during pregnancy. In its judgment, the court fixes between 1984 and 2006 the period of time during which the risk of congenital malformations was not sufficiently taken into account. For neurodevelopmental disorders, which took longer to be recognized, he reduced this period to 2001-2006.

“A defective product”

Based on the scientific information available at the time, the court considers that Sanofi “Produced and marketed a defective product between May 22, 1998 and January 2006 for congenital malformations and between 2001 and January 2006 for neuro-developmental disorders”. He also ordered that wide publicity be made to the possibility open to patients and their children to participate in this group action.

→ READ. Dépakine: the state ordered to compensate three families

The women concerned and their children born between 1984 and January 2006, for congenital malformations, and between 2001 and January 2006, for developmental and cognitive disorders, have five years to do so.

Sodium valproate has been marketed since 1967 under the brands Dépakine (for patients with epilepsy), Dépakote and Dépamide (for bipolar patients), as well as under generic brands. This molecule is responsible for malformations in 2,150 to 4,100 children and neurodevelopmental disorders in 16,600 to 30,400 children, according to estimates from the health insurance and the Medicines Agency (ANSM).

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