Drifting too far from shore: paternal valproate statement by the European Medicines Agency (EMA)

Summary

• Transparency is pivotal to trust between clinicians, academics, and regulatory authorities.
• Data and methodology supporting regulatory decisions must be made publicly available.
• Measurements of neurodevelopmental outcomes are complex and controversial.
• Data on paternal exposure to valproate are insufficient to warrant far-reaching precautions.
• Regulatory, academic, and clinical collaboration is essential to communicate risk.