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 (in the womb) to valproate are at a high risk of serious developmental disorders (up to 30-40%) and congenital malformations (approximately 11%).
There are important contraindications, strengthened warnings and risk minimisation measures to prevent valproate (Epilim▼) exposure during pregnancy.
Treatment with valproate (Epilim▼) must be initiated and supervised by a suitably experienced specialist. Valproate (Epilim▼) must not be used in girls and women of childbearing potential (i.e. those that can become pregnant) unless other treatments are ineffective or not tolerated, and the terms of a pregnancy prevention programme, known as ‘prevent’, are followed. The pregnancy prevention programme ‘prevent’ 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 ‘prevent’ are provided in educational materials for patients and healthcare professionals below:
Patients should not stop taking valproate without consulting a doctor
It is important that women and girls who have been prescribed valproate should not stop taking their medicine without consulting their doctor. Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures that could have serious consequences for the woman, and if pregnant, the unborn child.
Reporting suspected side effects (adverse reactions)
Valproate–containing medicines (Epilim▼) are subject to additional monitoring requirements and healthcare professionals and members of the public are requested to report any suspected adverse reactions associated with use via the HPRA reporting forms. Any medicine subject to additional monitoring in the EU is identifiable by an inverted black triangle after the medicine's name ▼ as well as the following explanatory statement in the product information.
▼ This medicinal product is subject to additional monitoring
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