Valproate-containing medicines (also known as sodium valproate or valproic acid) are approved in Ireland under the brand name Epilim, to treat epilepsy and bipolar disorder. Valproate (Epilim) can cause birth defects and problems with the development and learning of the child if their mother takes this medicine during pregnancy. Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).
In 2014, an EU-wide review led to strengthening of restrictions for use of valproate and further characterisation of the risk of birth defects and developmental disorders in the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)). The impact of the risk minimisation measures was the subject of a further review initiated in 2017 and the recommendations arising from this review were published and endorsed in February and March 2018. (Please see the link below to the EMA website for more information on the EU reviews.)
There are now important new contraindications, strengthened warnings and measures to prevent valproate (Epilim) exposure during pregnancy. Valproate (Epilim) must not
be used in girls and women who may be able to have children unless the terms of the pregnancy prevention programme
are followed. This programme includes measures to ensure patients taking valproate (Epilim) are fully aware of the risks and the need to avoid becoming pregnant while taking it. Details of the pregnancy prevention programme
are listed in section 4.4 of the Summary of Product Characteristics (SmPC) which is part of the product information (please see below). It is important that women and girls who have been prescribed valproate should not stop taking their medicine without consulting their doctor.
Valproate (Epilim) - Product information
The approved product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL))* includes detailed warnings and recommendations for healthcare professionals and patients regarding use of valproate, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. Copies of the current versions of the product information are available from the HPRA website, under 'Find a Medicine' or see Valproate Product Information page below.