Safety Alert 7 December 2023

Sodium valproate (Epilim) use in people who can father children:

important new safety information
Update to original communication

The Epilim data sheet and consumer medicines information leaflet have been recently updated with additional information about sodium valproate (Epilim) use in people who can father children.

Educational resources are also being updated.

The additional information includes the following.

Use of sodium valproate in people who can father children within the 3 months prior to conception may increase the risk of neurodevelopmental disorders in the child.

The potential risks to children fathered more than 3 months (the time taken for new sperm to be formed) after stopping sodium valproate are unknown.

If stopping sodium valproate, continue effective contraception for 3 months.

Do not donate sperm while taking sodium valproate and for 3 months afterwards.

Correction to the retrospective observational study results following reanalysis of one data set.