News Category: Regulatory news
The HPRA has updated its website regarding the use of Valproate (Epilim▼) in women of childbearing potential and during pregnancy. The webpage now contains the most up-to-date guides for patients and healthcare professionals, which were updated in February 2022. Additionally, the HPRA has made changes to the layout of the website content and relevant information and resources are now accessible from one central webpage: hpra/valproate.
Valproate-containing medicines 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. There are important contraindications, strengthened warnings and risk minimisation measures to prevent valproate (Epilim▼) exposure during pregnancy.
The HPRA’s valproate webpage contains important safety information for women taking Epilim▼ and for healthcare professionals involved in their care. The page includes:
educational materials including guides for patients and healthcare professionals updated in February 2022;
HPRA-approved communications, including a Drug Safety Newsletter published in February 2022 containing important safety information for healthcare professionals;
information about reporting suspected side effects;
product information, including the package leaflet containing information for patients and the Summary of Product Characteristics (SmPC) containing information for healthcare professionals;
links to external resources for patients and healthcare professionals.