Valproate for men: Statement from the Swiss Epilepsy League

Paternal exposure to valproate has now also been linked to potential risks for children; the Swiss League Against Epilepsy is advising against any hasty changes in therapy in response to this information.

September 2023 – In a safety information statement dated 24 August 2023, Swissmedic pointed out the potential higher risk of neurodevelopmental disorders in children of fathers treated with valproate, compared to the risk for children of fathers treated with lamotrigine or levetiracetam.

The information from Swissmedic is based only on initial data from a retrospective evaluation that has not yet been completed and published. Therefore the cause, frequency and severity of these developmental disorders have not yet been fully investigated.

The Swiss Epilepsy League recommends that male patients be made aware of this potential risk, but that no change in therapy be initiated at present if the epilepsy is well controlled with valproate. In our opinion, based on the current data, it is not necessary at this point in time to actively contact all patients taking valproate.

In cases where anti-seizure medication is to be prescribed for the first time, the efficacy and side effects of the drug should continue to be considered carefully when deciding which drug should be given as the first choice.

We also refer to the statement from the European Medicines Agency (EMA), which points out possible shortcomings of the current study:

https://www.ema.europa.eu/en/news/ema-review-data-paternal-exposure-valproate

The Swissmedic release: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/potenzielles-risiko-valproat.html