Minister for Health Stephen Donnelly is to commission an inquiry into the historical licensing and use of a controversial anti-epileptic drug in Ireland.
Up to 1,250 children born between 1975 and 2015 may have experienced some form of neurodevelopmental delay after the use of the epilepsy drug, sodium valproate, by their mothers while pregnant, according to the HSE.
Last July, an independent inquiry into the use of the drug in the UK resulted in recommendations from the Independent Medicines and Medical Devices Safety Review, such as an apology from the British government to those affected by the drug and a redress scheme to meet the cost of providing additional care and support.
The final report, "First Do No Harm", was followed by a call from the Organisation for Anti-Convulsant Syndrome for a similar inquiry to be commissioned here.
The drug, sold as Epilim, which is a commonly used treatment for epilepsy and bipolar disorder, has proven to be harmful to the foetus if taken during pregnancy in some cases, resulting in foetal valproate syndrome.
The report revealed that users of the drug were not made aware of the dangers of taking Epilim while pregnant by their healthcare professionals.
Defects from valproate exposure in the womb include developmental delay and a variety of malformations such as neural tube defects, cardiac and genitourinary malformations and limb defects.
The commitment to an inquiry was confirmed in a statement from the Department of Health which said the process would be streamlined and built on existing knowledge and findings from other jurisdictions.
Testimonies from families affected by disabilities associated with the drug will also be central to the inquiry.