Sodium valproate "Epilim", a drug of worldwide concern, can cause serious growth defects

Sodium valproate "Epilim", a drug of worldwide concern, can cause serious birth defects and growth defects during pregnancy. Ireland's Health Minister Stephen Donnelly will today win Cabinet approval for an investigation into the prescribing of drugs that cause birth defects.

If sodium valproate is taken during pregnancy, it can cause serious birth defects and growth disorders. An investigation into the historical use of sodium valproate, prescribed as an anti-seizure drug to women while pregnant, is expected to win approval.

Sodium valproate is a drug sold in Ireland under the brand name Epilim, which has been licensed and prescribed worldwide since the 1970s, primarily for the treatment of epilepsy, and the drug has been licensed in Ireland since 1975.

If sodium valproate is taken during pregnancy, it can cause serious birth defects and developmental defects in the baby, and women are advised not to use it unless other treatments are not possible. The drug was prescribed in Ireland and elsewhere for years after the risk was discovered, and now many countries

The Health Products Regulatory Authority (HPRA) says the drug can cause birth defects and problems with the child's growth and learning if taken by the mother during pregnancy. Children exposed to the drug during pregnancy have a high risk of severe developmental disorders (up to 30-40% of cases) and birth defects (about 10% of cases). Symptoms of fetal valprot syndrome (FVS) vary, but may include facial features, spinal bifida, congenital heart defects, cleft lip and/or palate, genital malformations, skeletal abnormalities, and growth delays.

The drug's risks to infants have been publicized in recent years, but campaigners in the UK have found documents in the National Archives which show that as early as 1973 health regulators were aware of the risks but chose not to warn patients. A HSE report published in 2018 estimated that 1,250 children had been infected in Ireland since 1975. In 2021, an investigation by Notworthy found that almost 3,000 Irish children were at risk of harm from exposure to the drug in the womb. In March, two medical negligence solicitors in Ireland called for a redress scheme to be established for children born with birth defects as a result of mothers being given anti-seizure drugs while pregnant.

In November 2020, Donnelly announced that it had committed to an investigation into the historical licensing and use of sodium valproate in Ireland. It comes under serious scrutiny in Ireland months after a review published a two-year investigation in the UK criticizing the failure of manufacturers, regulators, clinicians and policymakers to uphold patient safety and take action on the risks the drug poses.

This drug is given under different names including in India. A similar investigation was conducted in France, where last year a French court allowed affected families to join a class action against the manufacturer, Sanofi.

A non-statutory inquiry is now expected to be established into the historical licensing and use of the drug in Ireland. Since sodium valproate was first licensed in Ireland, it is the intention of the Minister and the Government to provide patients and their families with an inquiry into its use.