The Global pharma company Sanofi has been formally charged over Depakine, a therapy for epilepsy that causes birth defects and impedes neurological development when taken during pregnancy. The compound sodium valproate was deemed to cause neurodevelopmental risks emerged. In 2015, authorities recommended that practitioners should no longer prescribe the treatment for women of childbearing age or pregnant women were enforced.
Yet the medicine which is on the WHO list of “essential medicines” — has been on the market since 1967 to treat epilepsy and bipolar disorder. Sanofi learned of the risk of fetus malformation in the 1980s. In 2003, the company became aware of the drug’s impact on the neurological development of the fetus, with a risk of autism or learning difficulties, according to the wire agency.
“It’s finally a great victory!” tweeted Marine Martin, president of the Association for the assistance of parents of children suffering from anti-convulsant syndrome (APESAC), which was set up in 2011. “My determination paid off, we will have our big criminal trial !!!”
The criminal investigation was initiated by APESAC, and forms of part of the process of the pending criminal investigation on Depakine before the Judicial Tribunal of Paris, a Sanofi spokesperson told Endpoints News. The French social affairs inspection agency IGAS has estimated that between 425 to 450 babies suffered congenital birth defects or were stillborn following exposure to Depakine from 2006 to 2014, according to estimates cited by Reuters. In 2017, a compensation scheme for victims was set up. Roughly 6.5 million euros has been provided in compensation to 31 victims, although nearly 2,000 claims have been filed, according to the French media group france info.
Sanofi is not participating in this fund, the spokesperson told Endpoints.
In a 2016 interview with Reuters, Sanofi said it would accept any blame attributed by a court over the drug.
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