The French medical safety authority is facing charges of injury and murder for negligence caused by the epilepsy drug valproate, which was sold by the pharmaceutical company Sanofi as Dépakine.
The National Agency for Security of Medicine and Health Products revealed that it has been accused and will cooperate with investigators.
Valproate taken by pregnant women is said to have caused infant health problems, including cleft palate, spina bifida, autism and learning disabilities.
Valproate was marketed as Epilim in the United Kingdom. The UK's National Institute for Health and Care Excellence published safety advice on valproate in 2019 and warned that children born to women who take the medicine during pregnancy are at risk of birth defects and developmental disorders.
ANSM said it is "fully aware of the victims' suffering and has been working for several years to limit exposure to valproate in women of childbearing potential.
The drug has been on the market since the late 1
Sanofi was accused in February of failing to warn pregnant women about the dangers of taking Dépakine.After a three-year investigation, French prosecutors accused the company of gross fraud and accidental damage. informed the health authorities about the link between Dépakine and birth defects, and requested updates of information to doctors and patients.Families with affected children say the council was too slow to be effective.
The French state set up a compensation system in 2017, which had paid 6 EUR 5 million ($ 7.7 million) to victims in February, according to British Medical Journal
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