Inquiry into historical use of sodium valproate in certain groups of women to be established

It has been announced that an inquiry into the historical licensing and use of sodium valproate in women of child-bearing potential in the State will be established.

Government approval to progress the inquiry has been received.

In a statement, the Department of Health said while valproate is an effective and essential treatment for some patients, valproate-containing medicines can cause birth defects and developmental disorders in children whose mothers take such medicines during pregnancy.

The purpose of this inquiry is to provide a voice to persons with a diagnosis of foetal valproate spectrum disorder, their mothers and other family members, according to the Department.

The inquiry will also seek to document the evolution of sodium valproate regulation and the practices around the control of this product.

The Chair of this inquiry will be tasked with assessing the health service’s current capacity to respond to safety issues relating to use of anti-seizure medications in women of child-bearing potential.

Minister for Health Stephen Donnelly said:

“Today I was delighted to secure Government approval for the establishment of an inquiry which will examine the licensing and use of sodium valproate in women of child-bearing potential in the State.

“When I met with the patient groups involved with this issue, I supported their call for an inquiry, and I am very pleased to be able to progress this.  This inquiry will be designed to give a voice to patients and their families while looking at the use of sodium valproate in Ireland since it was first licensed. 

“There is work to be done before the non-statutory inquiry can commence, but this is an important milestone, and my officials will now work to bring this forward”.

Minister Donnelly added:

“Sodium valproate continues to be an essential part of the treatment plan for some patients and is an effective medication. It is important that people who are currently taking sodium valproate do not make any changes to their treatment without discussing any concerns they have with their doctor in the first instance.”