The National Medicines Safety Agency (ANSM) modifies the conditions for prescribing and dispensing medicines based on valproate and derivatives and carbamazepine from January 6, 2025, in connection with the risks for the unborn child. The agency is also strengthening information for patients and healthcare professionals. Press release.
The ANSM details on its website the changes to the conditions for prescribing and dispensing medications based on valproate and derivatives (Dépakine, Micropakine, Dépakote, Dépamide, Divalcote and generics) and carbamazepine (Tegretol and generics) from January 6 2025, in relation to the risks for the unborn child.
• Valproate in adolescents and men likely to have children: reinforced information and restriction of the initial prescription to neurologists, psychiatrists and pediatricians
For adolescents and men likely to have children, the initial prescription of treatment will be reserved for neurologists, psychiatrists and pediatricians from January 6, 2025 and from June 30, 2025 for patients already treated. Subsequently, renewal of the treatment can be prescribed by any doctor. A certificate of shared information must be co-signed each year by the patient and their doctor (neurologist, psychiatrist or pediatrician during initiation or any doctor during renewals). The presentation of this co-signed certificate will determine the dispensing of the medication in the pharmacy.
• Valproate in girls, adolescents and women: replacement of the care agreement form with a shared information certificate
As of January 6, 2025, the care agreement form is replaced by a certificate of shared information, co-signed at least once a year by the patient and the prescriber. For patients already treated, the care agreement form will remain valid until the end of its year of validity.
• Carbamazepine: strengthening information for women likely to have children by establishing a shared information certificate
In order to limit the exposure of unborn children to carbamazepine, the conditions for prescribing and dispensing this medication are reinforced for girls, adolescents and women likely to have children or who are pregnant. A certificate of shared information, co-signed each year by the patient and the prescriber, must now be presented to the pharmacist, in addition to the prescription, for any dispensing of carbamazepine-based medication. This measure will come into force from January 6, 2025 for treatment initiations and from June 30, 2025 for patients currently undergoing treatment.
• Valproate and risks for the unborn child: prescription and delivery conditions are changing for adolescents and men likely to have children, December 13, 2024, ANSM.
• Carbamazepine and pregnancy: strengthening information for women to make them aware of the risks incurred by unborn children, December 13, 2024, ANSM.
