The National Medicines Safety Agency has modified “the conditions of prescription and dispensing” of medications indicated for epilepsy, including Dépakine.
Dépakine caused a major 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. For years, this medicine – and its generics – have been subject to strict prescription and delivery conditions.
Since January 6, 2025, conditions have once again become tougher. 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.
Change also for other anti-epileptic drugs
Valproate-based medications are not the only ones affected by changes in prescription and dispensing conditions. Since January 6, 2025, these conditions have also changed for drugs based on carbamazepine (Tegretol and generics, indicated against epilepsy and bipolar disorders) and topiramate (Epitomax and generics, indicated against epilepsy and migraine).
A certificate of shared information co-signed by the patient and the prescribing doctor must also be presented to the pharmacy to obtain treatments based on carbamazepine and topimarate. 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.
