strengthened prescription and delivery conditions in 2025

For several years now, the ANSM has been tightening its policy towards anti-epileptic drugs deemed to be risky during pregnancy. New measures, which will come into force on January 6, 2025, are once again moving in this direction in order to protect unborn children from the risks of neurodevelopmental disorders and malformations linked to exposure, particularly in utero, to three types of medications.

Teratogenic risks linked to valproate, carbamazepine and topiramate

The drugs affected by these new measures are those based on valproate and derivatives (Dépakine, Micropakine, Dépakote, Dépamide, Divalcote and generics), carbamazepine (Tegretol and generics) and topiramate (Epitomax and generics). In question, their teratogenic risk.

“Exposure to carbamazepine [un médicament utilisé pour traiter certaines formes d’épilepsie, des troubles bipolaires, des épisodes maniaques et des névralgies rebelles de la face, ndlr] during pregnancy is associated with a risk of major malformations for the unborn child (multiplied by three compared to children not exposed to an antiepileptic drug) and neurodevelopmental disorders”, details the ANSM. “The malformations most often encountered are anomalies of the neural tube (opening of the spinal column), a malformation of the face such as a cleft of the upper lip and palate, a malformation of the skull, anomalies of the heart, a malformation of the penis involving the urinary opening (hypospadias) and abnormalities in the fingers.”

For topiramate, a treatment indicated for epilepsy and migraine prevention, the risks concern malformations and the occurrence of autism spectrum disorders (up to 6%), intellectual disability (up to 8%) and a risk of ADHD.

Finally, for valproate and its derivatives, used in the treatment of epilepsy and bipolar disorders, there is a high risk of congenital malformations, up to 11% and up to 30 to 40% risk of neurodevelopmental disorders. .

A prescription reserved for certain healthcare professionals for valproate

From January 2025, adolescents and men likely to have children will only be able to be prescribed valproate by neurologists, psychiatrists and pediatricians. “Continuation of treatment may be prescribed by any doctor.”, specifies the ANSM, but will require, from the patient and the prescriber, the annual presentation of a certificate of shared information.

Concerning topiramate and carbamazepine, the shared information certificate will replace the agreement form for girls, adolescents and women, with a signature which must be renewed each year. To obtain the medicine in question, this certificate must also be presented to the pharmacist in addition to the medical prescription.