Dépakine Risk Extends to Fathers, French Study Confirms
A large-scale French study has confirmed that valproate, commonly known as Dépakine, poses a risk of developmental disorders in children even when taken by fathers prior to conception. The research,analyzing nearly three million births between 2010 and 2015,reinforces growing concerns about the medication’s impact on fetal progress and is prompting stricter prescription guidelines.
While the risk is perhaps less frequent when the father takes valproate compared to the mother, the consequences for the child can still be serious, according to Dr. Philippe Vella,medical director of the French National Agency for the Safety of Medicines and Health Products (ANSM). The findings come as several countries, including France, are already limiting Dépakine prescriptions to prospective fathers, with new regulations in France set to take effect in 2025 restricting initial prescriptions to neurologists, psychiatrists, and pediatricians.
The study highlights a critical dilemma for patients with epilepsy or other conditions treated with valproate. Abruptly stopping the medication “can be extremely harmful,” Dr. Vella cautioned, emphasizing the need for open dialog between patients and their doctors when family planning is considered.
The research was conducted by Epi-Phare and published alongside an investigative report by Le Monde detailing the experiences of families affected by Dépakine-related birth defects near the Sanofi factory in Mourenx, France.
