New twist in the Dépakine® case. According to information from Figaro, the Paris prosecutor’s office opened a preliminary investigation at the end of September 2015 on the conditions for authorization and marketing of this antiepileptic. The latter would be responsible in France for nearly 400 fetal malformations between 1986 and 2015, 54 miscarriages and infant deaths.
Behavioral and nervous system disorders
Prescribed against seizure disorders and certain psychiatric disorders, Depakine® contains valproat. When ingested by a pregnant woman, this compound may cause fetal malformations and neurodevelopmental disorders leading to nervous and motor system abnormality, forms ofautism and behavioral problems.
Late warnings?
But the warnings on these risks did not appear in the notices until 2006, under the mention “if a pregnancy is planned, all measures will be implemented to consider the use of other therapies”. However, the first scientific results highlighting these dangers already exist in the mid-1990s. Until the opening of this new examination, only the General Inspectorate of Social Affairs (Igas) was investigating the drug Depakine®, at the request of the Minister of HealthMarisol Touraine in July 2015, in order to analyze the “decision-making mechanisms and conditions of use of this drug“. The Paris prosecutor’s office will now have to assess whether the Sanofi laboratory, which has marketed this drug since 1967, and the health authorities have transmitted scientific knowledge to doctors and patients early enough.
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