Calls for independent inquiry into epilepsy drug sodium valproate

A patient group representing families who claim they have been affected by the epilepsy drug, sodium valproate, has called on the Government to commission an independent inquiry into the use and licencing of the drug in Ireland.

The Organisation for Anti-Convulsant Syndrome (OACS) Ireland issued the call following today's publication of a report from an independent inquiry in the UK, chaired by Baroness Julia Cumberlege.

The report, "First Do No Harm," from the Independent Medicines and Medical Devices Safety Review, recommended that the British government apologise to families who have been affected by the drug.

It also recommended that a redress scheme be established to help the families meet the cost of providing care for their family members.

The UK report has led to calls from patient groups and politicians here that Ireland follow suit.

The report described sodium valproate as an "anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy".

The drug is known to be an effective treatment for epilepsy.

However, in some cases, it can be harmful to the foetus when taken during pregnancy. Many women who were prescribed the drug say that the potential harmful effects of the drug were not communicated to them by healthcare professionals.

The UK report noted that sodium valproate (sold under the brand name, Epilim) was "an effective treatment for many" of the people who took the drug to treat epilepsy.

"But this cannot justify the damage done to those who have suffered without prior knowledge of the dangers they faced, which could take years to present," the report said.

It also noted that since 1972, there was evidence that valproate could cause physical and neuro developmental effects in children if taken by mothers during pregnancy.

The pharmaceutical company Sanofi manufactures the drug.

A spokesperson for the company told RTÉ News: "Sanofi has complied with its regulatory obligations in relation to Epilim, including the provision of product information to healthcare professionals and to patients as approved by the competent regulatory authorities."

He said that the company will "study the recommendations and conclusions of the Review and consider the government's response".

Sodium valproate has been licenced in Ireland since 1975 for the treatment of epilepsy. It was subsequently licenced for treating bipolar disorder.

The HSE has estimated that up to 1,250 children born between 1975 and 2015 may have experienced some form of neurodevelopmental delay because of in utero exposure to valproate.

Karen Keely, the chairperson of OACS Ireland, gave evidence before the UK review.

Ms Keely said: "Thousands of families impacted by sodium valproate in the UK will be feeling a range of emotions this morning. Grief for the child they could have had; anger over the fact this was allowed to happen repeatedly over four decades; and relief that they now know their children's disabilities were through no fault of their own.

"We are very happy for our colleagues in OACS UK who are a step closer to justice but our focus remains on what needs to be done on our own shores."

Ms Keely, who has three adult sons with foetal valproate syndrome, said that an independent inquiry is now paramount here in Ireland.

She said that the French government has already commissioned a redress scheme for families affected by the drug and said that Ireland should follow this example.

While an opposition TD, the new Minister for Health, Stephen Donnelly, said that he was "100%" behind an inquiry into sodium valproate. He previously told the Medical Independent, "I don't understand how it hasn't happened."

At the time of publication, a spokesperson from the Department of Health had not responded to a query from RTÉ News, asking if the Minister continued to support an independent inquiry.

Sinn Féin TD Rose Conway-Walsh called on the new Minister for Health to honour "his commitment to hold an independent public inquiry into the valproate scandal".

Ms Conway-Walsh also said that the Minister should "put in place a redress scheme for the 1,200 plus families impacted by the failure of the state to protect them".

Some of the families affected by the sodium valproate issue have commenced legal proceedings in the High Court.

Meanwhile, the Healthcare Products Regulatory Authority (HPRA), the Irish authority that regulates healthcare products, said that while "the review was of the UK healthcare system, the HPRA is aware from its ongoing engagement with patient groups over the last number of years, that patients in Ireland have had similar experiences in the past".

"The HPRA is now examining the report and its recommendations to determine those aspects relevant to regulation of medicines and will consider the need for further action."

Conn Corrigan RTÉ Investigates

July 2020