Sanofi faces probe over birth defects linked to epilepsy drug

Feb. 4, 2020

A prosecutor in Paris has launched an investigation into Sanofi’s marketing of an epilepsy medication linked to birth defects.

According to the French drugmaker, the probe is related to Depakine, which contains sodium valproate, a molecule that has been on the market since 1967 to treat epilepsy and bipolar disorder. The medication is prescribed in over 100 countries and considered an “essential medicine” by the World Health Organization.

Sanofi reportedly became aware of the potential risk of causing malformations in fetuses exposed to the drug in the 1980s, and in 2003, that it could cause neurological damage. France’s social affairs organization estimated that up to 450 babies suffered from birth defects or were stillborn between 2006-2014 because of their exposure to Depakine.

Sanofi said it is fully cooperating with the investigation and that if the case goes to trial it will “prove it has always complied with its duty to inform and been transparent.”

Read the Reuters report.