Sanofi indicted on manslaughter charges over its epilepsy drug Depakine

pharmafile | August 4, 2020 | News story | Manufacturing and Production |  Sanofi, Vaccine 

Sanofi is being investigated for manslaughter in France over the deaths of four babies whose mothers took its anti-epilepsy medication Depakine.

Sanofi has denied the charges and stated it will challenge the investigations, saying that “all these elements do not in any way prejudge the responsibility of the company.”

France’s social inspection agency, the IGAS, has estimated that from 2006 and 2014, 425 to 450 babies suffered birth defects or were even stillborn due to exposure to Depakine. Representatives for the four families said the decision to launch the investigation was a “great victory.”

The latest chargers follow a probe into Sanofi that was launched in September 2016 to investigate how the drugs active molecule, valproate, contributed to the deaths of infants. In the past this ingredient had been linked to certain conditions in children. Sanofi was charged with aggravated fraud and unintentionally causing injury in this case.

The drug has faced criticism since the drug was first approved in 1967, with France’s health agency (ANSM) being one of the most prominent critics. They estimate that the drug has caused serious congenital malformation, with between 2,150 to 4,100 cases since its approval. The company has been aware of the complications in pregnant women since the 1980s.

Valporate is widely prescribed around the world and known under multiple branded names included Epilim and Stavzor.

Conor Kavanagh