Published: June 2023, Last updated: September 2023
The European Medicines Agency (EMA) is currently evaluating the results of a study to assess the risk of neurodevelopmental disorders, including autism spectrum disorders, as well as congenital abnormalities (birth defects) in children whose fathers were treated with valproate in the three months preceding conception.
Pharmaceutical companies that market valproate-containing medicines were requested to conduct this study by EMA, as one of the outcomes of a European safety review on valproate that concluded in 2018.
The study was conducted using data from several registry databases in Norway, Sweden and Denmark and compared children whose fathers were treated with valproate in the three months preceding conception with children whose fathers were treated with lamotrigine or levetiracetam (other medicines to treat epilepsy and/or bipolar disorder).
The results may indicate an increase in the risk of neurodevelopmental disorders in children whose fathers were treated with valproate compared with children born to fathers treated with lamotrigine or levetiracetam. However, this finding may be subject to change.
The reason why the finding may change is because after submitting the study results, the companies who conducted the study informed the EMA of errors in the Norwegian dataset, the impact of which is not yet known. In addition, important limitations of the current data, including questions about the definitions used for neurodevelopment disorder in the study as well as the specific types of epilepsy the fathers had, have been identified. The EMA has requested companies to provide analyses of corrected data and additional analyses to address study limitations as soon as possible. The finding based on the initial results is therefore subject to change.
The outcome of this evaluation will be communicated to patients and healthcare professionals as soon as it is available.
On 16 August 2023, the EMA published further information about this ongoing review on their website.
On 15 September 2023, the HPRA approved the distribution of a Direct HealthCare Professional Communication in Ireland on the ongoing review.
If you are a man being treated with valproate (Epilim▼), do not stop taking your medicine without talking to your doctor, as your epilepsy or bipolar disorder could become worse. Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures.