New measures to avoid valproate (Epilim) exposure in pregnancy endorsed by national medicines agencies

News Category: Regulatory news

Date: 23/03/2018

The HPRA welcomes the endorsement by the CMDh* of the strengthened regulatory position on valproate (Epilim) medicines. The HPRA has been a significant contributor to the Europe-wide review that has resulted in a series of new safety measures that are being introduced to avoid exposure of babies to valproate medicines in the womb, due to risks of birth defects and developmental problems. 

In the interests of patient safety, we have already commenced work to implement these measures in Ireland and are engaging directly with national stakeholders including patient representatives and healthcare professionals. The priority for all parties involved is on ensuring that women and girls are aware of the very real risks of taking valproate during pregnancy. 

We do wish to emphasise, however, that women should not stop taking valproate without first discussing it with their doctor.

Further information can be found on the website of the European Medicines Agency

*The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.

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