Various regulatory authorities are currently evaluating data on the potential risk of neurological development disorders in children conceived by fathers taking valproate. As a precaution, Swissmedic is revising the medicinal product information for products containing valproate in order to warn men of the potential risks of this active substance to the unborn child. Those affected should under no circumstances discontinue their treatment without consulting their doctor.
Precautionary change to the medicinal product information for valproate products
Retrospective observational studies indicate a potential increased risk of neurological development disorders in children whose father was taking valproate in the three months prior to and/or at the time of conception. The risk assessments are ongoing; no final conclusions can currently be drawn from the study results.
In light of this, patients who wish to have children in particular should contact their doctor to discuss the need for effective contraception or possible alternative treatments.
Male patients taking valproate should not discontinue treatment without consulting their doctor as symptoms of their condition may worsen. Unauthorised, sudden discontinuation of epilepsy treatment can trigger seizures. Patients with questions about their treatment should discuss this immediately with their doctor.
The existing precautionary measures for women due to the risk of congenital malformations (birth defects) and neurological development disorders during pregnancy should also be observed: