The Paris Administrative Court of Appeal issued a court decision, finding the State “partially” responsible.
A new twist in the Dépakine affair. In its court decision published on January 14, 2025, the Paris Administrative Court of Appeal ruled that “by not modifying the marketing authorization for Dépakine so that patients are sufficiently informed of the risks for the fetus in the event of exposure to this drug, the agency responsible for the safety of the drug failed in its obligations and committed an error involving the responsibility of the State. The health authorities should have informed the patients sooner, since there were “serious suspicions highlighted by existing studies”, according to the court. The State must therefore “partially repair the consequences of the insufficient information given to doctors and patients on the risks for the unborn child”.
As a reminder, Dépakine, marketed by the Sanofi laboratory, caused a huge health scandal. Tens of thousands of pregnant women with epilepsy or bipolar disorder had taken sodium valproate, a molecule contained in Dépakine and other medications, without knowing that it can cause serious birth defects and disorders. neurodevelopmental disorders in children.
Modified delivery conditions
For years, this medicine – and its generics – have been subject to strict prescription and delivery conditions. Since January 6, 2025, these conditions have been tightened once again. This decision by the National Medicines Safety Agency (ANSM) follows a study – conducted by the European Medicines Agency and published in August 2023, editor’s note – suggesting an increased risk of neurodevelopmental disorders in children. whose father was treated with valproate in the three months before conception”, recalls the Agency. Until now, only women were affected by strict conditions for dispensing valproate-based medicines.
So in concrete terms, adolescents and men “likely to have children” can now only be prescribed treatment based on valproate by a neurologist, a psychiatrist or a pediatrician. Subsequently, “renewal of the treatment may be prescribed by any doctor”, specifies the ANSM. Also, to obtain treatment in a pharmacy, male and female patients will have to present a “shared information certificate”, signed by themselves and their doctor.
Valproate-based medications are not the only ones affected by changes in prescription and dispensing conditions. A certificate of shared information must also be presented in pharmacies to obtain treatments based on carbamazepine (Tegretol and generics, indicated against epilepsy and bipolar disorders) and topimarate (Epitomax and generics, indicated against epilepsy and migraine ). Finally, topimarate as a preventive treatment for migraine, which until now could only be prescribed by neurologists, can now also be prescribed by “competent pain doctors”. All of these changes aim to limit exposure to these teratogenic drugs and to better inform patients.
