Dépakine Scandal Deepens: Father’s Use Before Conception Now Linked to Child Neurodevelopmental Issues
PARIS, FRANCE – November 7, 2024 – The decades-long controversy surrounding the anti-epileptic drug Dépakine (valproate) has taken a dramatic turn. A groundbreaking new study published today reveals a significant link between valproate use by fathers in the months leading up to conception and an increased risk of neurodevelopmental disorders in their children. This revelation expands the scope of the already massive drug-related scandal, previously focused on the risks to children of mothers taking the medication during pregnancy. This is a breaking news development with serious implications for families and pharmaceutical accountability.
New Study Reveals Increased Risk – Even From Father’s Exposure
The large-scale study, conducted by the Epi-Phare group – a collaboration between the French National Medicines Agency (ANSM) and Health Insurance – analyzed data from 2.8 million births in France between 2010 and 2015. Researchers found that children born to fathers treated with valproate during the three months before conception had a doubled risk of developing an intellectual development disorder compared to children whose fathers took alternative antiepileptic drugs like lamotrigine or levetiracetam. Overall, the risk of any neurodevelopmental disorder increased by 24%.
“We are seeing a potentially less frequent risk when the treatment is taken by the father rather than the mother,” explained Philippe Vella, medical director of the ANSM. “However, these are potentially serious consequences for the child.” The study specifically highlighted increased risks of intellectual disability, attention deficit hyperactivity disorder (ADHD), and disorders on the autism spectrum, though further research is needed to confirm the latter findings.
Dépakine: A History of Controversy and Legal Battles
Valproate, marketed under the brand names Dépakine, Depakote, and Dépamide (among others) by Sanofi, is widely prescribed for epilepsy and bipolar disorder. For years, the drug’s severe risks to developing fetuses – including malformations and developmental delays – were downplayed or inadequately communicated. This led to a massive public health scandal and numerous legal proceedings.
While Dépakine is now contraindicated for women during pregnancy (with limited exceptions), this new research underscores the need for a broader understanding of the drug’s potential impact on reproductive health. The findings are particularly poignant given the ongoing legal battles against Sanofi for lack of vigilance and information regarding the drug’s risks. Just last January, the French justice system confirmed the State’s partial responsibility for “insufficient information” provided to patients and doctors.
What Does This Mean for Families and Future Prescriptions?
The Epi-Phare study is already prompting renewed calls for precautionary measures. In France, regulations implemented in 2025 restrict Dépakine prescriptions for adolescents and men likely to have children, requiring a “certificate of shared information” co-signed by the doctor and patient. The European Medicines Agency (EMA) issued a warning in 2023 regarding potential developmental risks, prompting similar restrictions in other countries.
However, abruptly stopping valproate treatment can be dangerous for patients with epilepsy. “In epilepsy, abrupt cessation of treatment can be extremely harmful,” Vella cautioned. “If a patient wishes to have a child and do without valproate, this is a dialogue that must take place with the doctor.”
Voices of Affected Families Demand Action
The news is not surprising to many families already impacted by Dépakine. Marine Martin, head of an association supporting parents of children with anticonvulsant syndrome, shared that numerous fathers have contacted her organization reporting children with autistic disorders or developmental delays. She hopes the study will expand eligibility for the compensation fund, which has already distributed €120 million to victims.
This evolving story highlights the critical importance of thorough drug safety research, transparent communication between healthcare providers and patients, and the long-term consequences of pharmaceutical negligence. As the science continues to unfold, Archyde will remain committed to providing up-to-date coverage and insightful analysis of this crucial public health issue. For more in-depth reporting on pharmaceutical safety and legal developments, explore our dedicated Health and Legal sections.
