The risks of valproate on the neurological development of newborns

The European Medicines Agency (EMA) has launched a new assessment of the possible risk of neurodevelopmental disorders in children born to men treated with valproate—used for epilepsy, bipolar disorder, and migraines —following the negative results of a Danish study that conflicts with others confirming the link.

The Pharmacovigilance Risk Assessment Committee (PRAC) will analyze new data from several health databases in Denmark, in which The aim of this study was to investigate whether there was a relationship between the use of valproate, levetiracetam or lamotrigine by men before conception and the development of neurodevelopmental disorders (NDD) in their offspring.

Valproate is a medication commonly used to treat epilepsy, bipolar disorder, and, in some countries, migraine.

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Neurodevelopmental disorders include conditions such as autism spectrum disorder, intellectual disability, language disorders, Attention Deficit Hyperactivity Disorder (ADHD), and certain movement disorders, all of which manifest early in childhood.

In January 2024, the PRAC had already recommended precautionary measures after analyzing a previous study conducted by the pharmaceutical companies that market valproate.

That study, based on medical records from Denmark, Norway, and Sweden, suggested a possible risk of NDD in the offspring of men treated with valproate in the three months prior to conception.

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However, the new study, which used only Danish data, found no evidence of an increased risk of ODD associated with paternal valproate use.

Given the discrepancy between the two studies, the PRAC has initiated a signaling procedure to further investigate the differences in results and has requested additional information from the marketing authorisation holders for valproate.

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AO