EMA Safety Committee Recommends Precautions for Valproate Medicines
The European Medicines Agency Safety Committee (PRAC) has recommended precautionary measures for the treatment of male patients with medicines based on valproate. The measures aim to prevent a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the three months before conception.
Valproate medicines are used to treat epilepsy and bipolar disorder, and in some EU member states, they are also authorized to prevent migraines. The latest recommendations from the PRAC come after a review of data from a retrospective observational study conducted by companies marketing valproate, as required following a previous review of the use of valproate during pregnancy.
The recommended precautionary measures range from a recommendation that treatment be initiated and supervised by a specialist experienced in the management of the disease, the need to consider effective contraception for the patient and his partner during treatment, and for 3 months after stopping treatment.
In addition to these measures, the PRAC also discussed a Direct Healthcare Professional Communication (DHPC) for valproate medicines. The DHPC will inform healthcare professionals about the potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the three months before conception. It is recommended that treatment with valproate in male patients be initiated and supervised by a specialist in the management of epilepsy, bipolar disorder, or migraine.
The PRAC has also initiated a procedure to review data on T cell-related secondary malignancies for six approved CAR-T (CAR) medicines. These medicines are used to treat blood cancers such as B-cell leukemia, B-cell lymphoma, follicular lymphoma, multiple myeloma, and mantle cell lymphoma in patients whose cancer has recurred or has stopped responding to previous treatment. The review will assess the need for any regulatory action in light of the available evidence.
These latest recommendations from the PRAC are in addition to the restrictions and measures already in place to avoid exposure to valproate during pregnancy, as exposed children are at high risk of malformations and developmental problems. Healthcare professionals and patients are urged to stay informed about these recommendations and to consult with specialists in the management of these conditions to ensure the safety and well-being of patients and their potential offspring.