Concern over state inaction on drug known to cause birth defects

The state’s failure to open an investigation into a drug that caused serious birth defects and developmental delays in at least 1,200 Irish babies is causing serious concern.

Sodium valproate, a drug used to treat epilepsy and bipolar disorder, is estimated to have caused major birth defects in up to 341 Irish children between 1975 and 2015 after being taken by their mothers during pregnancy.

The drug, which is sold in Ireland as Epilim, is also believed to have caused neurodevelopmental delays in 1,250 children.

Many women have never been warned of the risks that taking this medication during pregnancy would pose to their babies.

Affected families have expressed dismay that a state drug investigation has yet to take place, two years after it was promised.

Epilepsy Ireland said it is ‘unbelievable’ the state still has not put in place a long-promised group of stakeholders to ensure no woman of childbearing age continues to take the drug unaware risks.

Sodium valproate, which is made by Sanofi, was the focus of a public inquiry in the UK after it was estimated that 20,000 children could have been affected by the drug.

Earlier this year, a French court allowed the families to join a class action lawsuit against the maker of the drug after it allegedly caused neurodevelopmental abnormalities in more than 30,000 children. In 2018, a European regulator backed a ban on the use of the drug during pregnancy.

In 2020, Health Minister Stephen Donnelly agreed to set up an inquiry into the licensing and use of the drug in Ireland.

However, two years later, the terms of reference for the non-statutory inquiry have still not been agreed. It is understood that the Attorney General raised concerns which slowed down the process.

The Irish Organization for Anticonvulsant Syndromes (OACS), a group of families affected by sodium valproate, said it had engaged with the government for more than a year without success.

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Karen Keely of OACS Ireland says families need to know

Karen Keely of OACS Ireland says families need to know

Karen Keely, spokesperson for OACS Ireland, said the organization had tried to agree on terms of reference “which will get to the heart of why and how this was allowed to happen to around 1,250 families in Ireland; families who are now caring for children with various serious and life-threatening disabilities caused by exposure to sodium valproate.

“Families want to know how this could continue for decades.

“We want an investigation that will provide the answers families deserve; and, indeed, one that will serve as a vehicle to ensure that no other woman or family is similarly affected in the future.

“The pace at which this process is evolving is becoming increasingly frustrating and putting additional pressure on already vulnerable families.

“We want this investigation to take place, but we have made it clear to the department that we will not facilitate a box-ticking exercise that does not provide what our families need – answers.”

The government has also promised to set up a stakeholder group that would bring together medical professionals and relevant organizations to try to ensure that sodium valproate is never again prescribed to women of childbearing age without the proper warnings. The stakeholder group has not yet been constituted.

“Given what we now know about the effects of sodium valproate, it is both infuriating and heartbreaking to think that a child could be born today in Ireland with preventative means.
disabilities from exposure to this drug and that a family should go through what we go through every day of our lives,” Ms Keely said.

Peter Murphy, chief executive of Epilepsy Ireland, said there was “more than enough evidence” to show the stakeholder group was urgently needed. He said that in the two years since the band’s pledge, two studies from the Royal College of Surgeons in Ireland (RCSI) have shown that there is a need to raise awareness among healthcare professionals about the risks of sodium valproate.

Mr Murphy said another study by his organization also showed that “a significant number of women were dangerously unaware of the potential impacts the drug could have”.

“It is incredible that the state has not yet acted on this issue. In 2022, the risk remains that a child could be born with valproate-related disabilities. This is simply unacceptable,” Mr. Murphy said.

A Department of Health spokeswoman said: “Department of Health officials are currently in discussions with patient groups and other stakeholders regarding the terms of reference for an investigation into the authorization and use history of sodium valproate.

“There is no timetable yet for the opening of the investigation.”

A Sanofi spokesperson said: “Taking appropriate steps to reduce the risks associated with all of our medicines is Sanofi’s top priority.

“We are committed to working with all concerned parties (regulators, prescribers, pharmacists and patients) to continue to educate about the risks and contraindications of valproate while continuing to make this essential medicine available to patients who need it. need.

When asked if Sanofi would cooperate with an Irish investigation, the spokesperson said: “We have not been contacted by any authority regarding a possible investigation in Ireland.”

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