French Agency Faces Manslaughter Charges Over Valproate Birth Defects
The medicines regulator, ANSM, says it has been working to limit women’s exposure to the drug.
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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.
A trial has begun in France to investigate the roles of the French firm Servier and the former drug regulator AFSSAPS in the Mediator scandal, where an amphetamine-like drug was kept on the market despite mounting evidence of its cardiac side-effects.
The European Medicines Agency has recommended that EU member states should introduce further restrictions on the use of valproate-containing medicines to avoid the drug's exposure in pregnancy.