Sanofi Faces Charges Over Valproate Birth Defects

French Regulator Planning More Preventive Measures

In a case that has parallels with that of Servier’s diabetes drug Mediator, Sanofi has been indicted over its alleged lack of transparency over the birth defects associated with use of its valproate drug in pregnant women.

Pregnancy_Pills
Sodium valproate caused fetal malformations when used in pregnancy • Source: Shutterstock

Sanofi has been charged with aggravated fraud and unintentional injury for allegedly failing to properly communicate the risk of birth defects in children born to women who had taken its sodium valproate epilepsy drug, Depakine.

Sanofi said it was informed of its status of “indicted party” on 3 February, as part of a criminal investigation...

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