France’s medical safety regulator has been charged with “injuries and manslaughter through negligence” for its handling of safety concerns related to a Sanofi drug.
The indictment relates to sodium valproate, the active ingredient in Depakine, which has been on the market since 1967 to treat epilepsy, migraines and bipolar disorder and is sold in over 100 countries. For decades, Depakine has also been at the center of one of France’s largest prescription drug scandals.
According to a court advisory panel in France, health regulators found out in 1983 that the drug was linked to birth defects when taken by pregnant women. In 2004, they also learned that it could increase the chances of learning disabilities and autism. Studies estimate that Depakine has now been linked to disabilities in 15,000-30,000 children.
In February, Sanofi said it is being investigated over its marketing of Depakine, but the drugmaker has maintained that it warned regulators about the risks in the 80s.
The regulator now being charged — The National Agency for Medicines and Health Products — said it is cooperating with investigators and has been working for years to limit the exposure of pregnant women to the drug.
