Rechte & Gesellschaft
EMA Committee Updates Advice on Valproate Risks
The European Medicines Agency's safety committee (PRAC) has reviewed the potential risk of neurodevelopmental disorders in children born to men treated with valproate. The committee concluded that the available evidence is inconsistent and does not confirm a risk. However, as a precaution, PRAC recommends that valproate treatment in male patients be started and supervised by a specialist. This updated advice aims to provide clarity for patients and healthcare professionals regarding the epilepsy and bipolar disorder medication.
EMA clarifies risk for men taking valproate but advises specialist supervision as a precaution.