On December 13, 2016, a group of people in France filed a class-action lawsuit against Sanofi, manufacturer of anticonvulsant drug Depakine (referred to in the US as Depakote).
The serious risks of birth defects of Depakine have been known in the US for decades, though France law has not allowed claims regarding pharmaceutical liability until September of this year. According to reports by France’s national drug agencies ANSM and CNAMTS, Depakine has been administered to over 10,000 women between 2007 and 2014.
In 2006, the US Food and Drug Administration (FDA) gave Depakine a “black box” warning after a study found that women who used the drug while pregnant had a 20 percent chance of delivering a child with a malformation or birth defect.
Information About Depakine
Depakine (sodium valproate) is used to treat epilepsy, bipolar disorder, and migraines. However, there are some serious side effects associated with its use. The birth defects that are associated with Depakine, and for which the class-action is based on, are:
- Arm and/or leg deformities
- Cephalic disorder
- Cleft palate
- Holes in the heart
- Low IQ
- Head or face deformities
- Extra or missing toes and fingers
- Mental disability
- Spina bifida