Notice type: 3rd Party Publications
Problem Or Issue:
Women to be better informed of the risks of valproate use during pregnancy.
The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has completed its review and recommended strengthening the restrictions on the use of valproate-containing medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb. The HPRA actively participated in this review and is in agreement with the outcome and recommendations.
The PRAC recommendation will now be considered by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) and the HPRA will be contacting Healthcare Professionals in due course.