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The French medical safety regulator faces prosecution for injuries and manslaughter by negligence caused by epilepsy drug valproate, which was sold by pharmaceutical firm Sanofi as Dépakine.
The Agence Nationale de Sécurité du Médicament et des Produits de Santé disclosed it has been indicted and will cooperate with investigators.
Valproate taken by pregnant women is alleged to have caused health problems in babies, including cleft palates, spina bifida, autism and learning difficulties.
Valproate was marketed as Epilim in the United Kingdom. The U.K.’s National Institute for Health and Care Excellence published safety advice on valproate in 2019, warning that children born to women who take the medication during pregnancy are at risk of birth defects and developmental disorders.
ANSM said it is “fully aware of the suffering of the victims and has worked for several years to limit exposure to valproate in women of childbearing age”.
The drug has been on the market since the late 1960s. It was also prescribed for migraines and bipolar disorder.
Sanofi was charged in February for failing to warn pregnant women of the risks of taking Dépakine. Following a three-year investigation, French prosecutors indicted the firm for aggravated deception and unintentional injuries.
Sanofi said it had informed healthcare authorities of the links between Dépakine and birth defects, and requested updates to information given to doctors and patients. Families of affected babies say the advice was too slow to be effective.
The French state set up a compensation scheme in 2017, which had paid out €6.5 million ($7.7 million) to victims by February, according to the British Medical Journal.
Commercial Risk Europe is a sister publication of Business Insurance. More stories from CRE here.