French health products agency yanked into legal battle over birth defects caused by Sanofi's Depakine
A probe into Sanofi’s epilepsy drug Depakine has now entangled France’s National Medicines and Health Products Agency (ANSM), which was indicted on Wednesday for “injuries and manslaughter by negligence” related to birth defects and stillborn births caused by the drug.
Sanofi found itself at the center of a manslaughter investigation in August, several months after it was formally charged. The drug, sodium valproate, has been on the market since 1967 for epilepsy and bipolar disorder. It’s on the WHO’s list of “essential medicines,” and is prescribed in over 100 countries. But according to Reuters, France’s social affairs inspection agency estimates 425 to 450 babies exposed to the drug suffered congenital birth defects or were stillborn from 2006 to 2014.
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