Government urged to investigate epilepsy drug used by pregnant women

A forum is estimating that as many as 400 children may have been affected

Several groups are calling on the Government to investigate into the current and historical use of the drug sodium valproate in pregnant women.

A French report revealed over 4,000 children were born with malformations since 1967 following exposure to the drug in the womb.

Valproate has been licensed in Ireland since 1983 for use in epilepsy and bipolar disorder.

The Foetal Anti-Convulsant Syndrome (FACS) Forum, which was established in 2013, estimates that the drug has affected at least 400 children with birth defects and developmental issues in Ireland.

The Forum, which consists of several groups - including The Disability Federation of Ireland, Epilepsy Ireland and the Genetic and Rare Diseases Organisation - has been working on this issue since the publication of the European Medicines Agency ruling on sodium valproate in 2014, which tightened restrictions on its use in women of childbearing potential.

Joan O’Donnell, chairperson of the Forum said: "The Government urgently needs to identify the scale of the problem, to assess the often complex needs of the families affected, and to put in place appropriate pathways for the diagnosis and treatment of Fetal Anti-Convulsant Syndrome.

"We would also call on the HPRA and the drug company to fulfill their promise from almost 12 months ago and immediately put warnings on the drug’s outer packaging to warn women who may still not be aware of the risks."

Epilepsy Ireland CEO Peter Murphy said: "While valproate has proven to be an effective medication for preventing seizures, all women or parents of girls taking valproate need to be aware of the risks involved. We urge them to speak to their medical team about this if they haven’t already to weigh up the pros and cons, but under no circumstances should they stop taking the drug without talking to their medical team."

French report

Up to 4,100 children in France suffered severe birth defects as a result of their mothers taking the drug, the French health authorities said.

The drug, also prescribed in France for bipolar disorder, was taken by up to 100,000 pregnant women between 1967 and 2016, according to a joint report by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance body.

Marketed in France under the brand name Depakine for epilepsy and Depakote or Depamide for bipolar disorder, it is one of the most effective and widely prescribed drugs for controlling epileptic seizures.

Parents of the children affected say the French government and the drug's manufacturer, Sanofi, were too slow to warn of the drug's side-effects - although the risks to foetuses were known by the early 1980s.