PARIS: French prosecutors have indicted pharma giant Sanofi for manslaughter over birth defects linked to an epilepsy drug, the company said Monday, in a long-running case that has also seen it charged with fraud.
The charges relate to the drug valproate, marketed as Depakine among other trade names, which studies say has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant.
On the market since 1967, the drug is used to treat epilepsy, migraines and bipolar disorder.
But research found that when pregnant women took the drug, their children had an elevated risk – between 10 to 40 percent – of congenital malformations, autism and learning difficulties.
Sanofi is facing separate charges of aggravated fraud and unintentionally causing injury in 42 cases filed by families, but insists it had warned health authorities of the drug’s risks already in the 1980s.