A French court has ordered pharmaceutical giant Sanofi to pay more than €400,000 in damages to a family whose child suffered from a form of autism caused by its epilepsy drug Valproate, saying the drugmaker failed to inform about known side-effects. French health authorities believe the drug was responsible for deformities in between 2,150 and 4,100 children, and neuro-developmental defects in up to 30,400 children.
Sanofi said in a statement it would appeal the decision, adding the drug’s overall risk-benefit ratio is positive.
Sodium valproate is commonly used to treat epilepsy, and by some people with bipolar disorder or migraines. However, it has been linked to an increased risk of birth defects and developmental problems if taken by pregnant women.
Reuters reports that the link, alongside physical malformation, had also been recognised in a landmark class action ruling in January, which could potentially lead to hundreds of millions of euros in compensation.
A MedicalBrief report on 20 April this year said the medication has been compared with thalidomide, the controversial anti-nausea drug dished out to pregnant woman some 50 years ago, resulting in thousands of birth defects worldwide.
Sanofi was placed under formal investigation in 2020 on charges of manslaughter, but rebutted those charges at the time and said it would challenge the merits of the investigation. That case arose from four infants’ deaths from 1990 to 2014. The infants died after their mothers had taken the drug during their pregnancies.
The latest ruling, made last week, states that Sanofi must have known the risk that the drug, if taken by pregnant women, could cause malformations and “neuro-behavioural disorders” in children, which should have been mentioned in its attached leaflet.
The court has ordered the company to compensate the parents of the girl for the various physical and psychological damages suffered, and resulting costs such as special care and schooling needs.
The verdict is the first in France to state a link between Valproate, sold under the name Depakine in France, and disorders commonly referred to as autism.
See more from MedicalBrief archives:
UK medicines’ regulator investigates unsafe epilepsy drug being given to pregnant women
Sanofi charged with manslaughter over French infant deaths
Poorer test results for children exposed to epilepsy drugs in the womb
Warnings on side effects of epilepsy drug came 40 years too late