French prosecutors have indicted Sanofi Aventis France for manslaughter over birth defects linked to the epilepsy drug, Depakine, as part of a long-running investigation.
Depakine, which has been on the market since 196 and lost patent in 1998, is prescribed around the world to treat epilepsy, migraines and bipolar disorder. According to Sanofi, the drugmaker no longer holds any rights to Depakine in the US, and sodium valproate generics are available in most markets.
Additional research in 2011 found that when pregnant women took valproate, their children had an elevated risk — between 10 to 40 percent — of congenital malformations, autism and learning difficulties. Following an investigation launched in 2016, French prosecutors moved forward with charges of aggravated fraud and unintentionally causing injury.
Today, Sanofi confirmed a report in Le Monde newspaper that prosecutors have now also charged the drugmaker with manslaughter.
Sanofi Aventis France has denied the charges and is challenging the merits of the investigation. The drugmaker insists it had warned health authorities of Depakine's risks in the 1980s.