Friday, January 28

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

A box of the anti-epileptic Dépakine used by relatives of victims, December 13, 2016 in Paris Agnès COUDURIER-CURVEUR

The Paris court ruled on Wednesday that Sanofi had “committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” on the risks of its drug Depakine for the fetus if taken during pregnancy.

He also ruled “admissible” the group action presented by the association of victims of Dépakine against the laboratory, paving the way for a first judicial in France in the field of health.

Sanofi has announced its intention to appeal the judgment.

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. deformities or developmental delays 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 neuro-developmental disorders, which took longer to be recognized, he reduced this period to 2001-2006.

Given 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 neurodevelopmental disorders”.

He also ordered that wide publicity be made to the possibility open to patients and their children to participate in this group action.

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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