Manufacturer Information: Risks of Valproic Acid Drugs for Neonatal Abnormalities

Manufacturers of medicines containing valproic acid, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), are issuing a 'Rote-Hand-Brief' (letter of information). This communication highlights the risks associated with the use of valproic acid (sodium valproate, valproic acid, valproate-semisodium, and valpromid) during pregnancy.

Children exposed to valproate in utero face a high risk of severe developmental disorders, estimated at 30-40 percent, and congenital malformations, around 10 percent. The drug should only be prescribed to girls, adolescents, women of childbearing potential, and pregnant women if other treatments are ineffective or not tolerated. Treatment must be initiated by a physician experienced in treating epilepsy or bipolar disorders.

Physicians are advised to carefully weigh the benefits against the risks when initiating treatment, during routine check-ups, when a girl enters puberty, and when a woman plans or becomes pregnant. All patients must be fully informed about these risks, the necessity of effective contraception, regular treatment reviews, and the need for immediate consultation if pregnancy is planned or occurs.

Valproic acid has been added to the EMA's list of medicines subject to additional monitoring, indicated by an inverted black triangle on packaging. Product information will be updated with specific sections detailing risks for female patients of childbearing potential, particularly concerning migraine prophylaxis. Manufacturers are also providing supplementary guidance and patient information materials.