Concerns about government inaction on drugs known to cause birth defects

There are major concerns over the state’s failure to launch an investigation into a drug that has caused serious birth defects and developmental delays in at least 1,200 Irish babies.

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

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

Many women were never warned of the risks that taking the drug while pregnant would pose to their babies.

Affected families have expressed their dismay that two years after the promise, a government investigation into the drug has still not been launched.

Epilepsy Ireland said it was “incredible” that the state still hasn’t set up a long-promised advocacy group to ensure no women of childbearing age continue to take the drug without being aware of the risks.

Sodium valproate, manufactured by Sanofi, has been the focus of a public inquiry in the UK after it was estimated that 20,000 children could be affected by the drug.

Earlier this year, a court in France allowed families to join a class action lawsuit against the drug’s maker after it was believed to have caused neurodevelopmental disorders in more than 30,000 children. In 2018, a European regulator backed a ban on the drug’s use in pregnancy.

In 2020, Health Secretary Stephen Donnelly agreed to launch an inquiry into the drug’s approval and use in Ireland.

Two years later, however, the terms of reference for the extrajudicial investigation have still not been agreed. It is understood the Attorney General had raised concerns that have slowed the process.

The Organization for Anticonvulsant Syndromes (OACS) Ireland, a group of families affected by sodium valproate, said it had been working 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, a spokeswoman for OACS Ireland, said the organization was trying to agree on a mandate “that gets to the heart of why and how this was allowed to happen to around 1,250 families in Ireland; Families now caring for children with a range of severe and life-limiting disabilities caused by exposure to sodium valproate.

“Families want to know how this could have continued for decades.

“We want research that provides the answers families deserve; and indeed one that will act as a vehicle to ensure that no other woman or family is affected in the same way in the future.

“The pace at which this process is progressing is becoming increasingly frustrating and putting further strain on already vulnerable families.

“We want this investigation to be done, but we have made it clear to the department that we will not conduct a checkbox exercise that does not provide what our families need – answers.”

The government also pledged to set up an advocacy group that would bring together medical professionals and relevant organizations to ensure sodium valproate is never again prescribed without proper warning to women of childbearing potential. The interest group has yet to be set up.

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

Epilepsy Ireland chief executive Peter Murphy said there was “more than enough evidence” to show the advocacy group was badly needed. He said that in the two years since the group’s pledge, two studies by the Royal College of Surgeons in Ireland (RCSI) have shown that there is a need for more 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 effects the drug could have”.

“It is unbelievable that the state has not yet acted on this matter. In 2022, there remains a risk that a child could be born with valproate-related disabilities. That’s just unacceptable,” Murphy said.

A Department of Health spokeswoman said: “Department of Health officials are currently discussing with patient groups and other stakeholders about the terms of reference for an investigation into the historical licensing and use of sodium valproate.

“There is still no timetable for the start of the investigation.”

A Sanofi spokesman said: “Sanofi has an absolute priority to take appropriate steps to reduce the risk of all of our medicines.

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

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

https://www.independent.ie/irish-news/health/concern-over-states-inaction-on-drug-known-to-have-caused-birth-defects-41901954.html Concerns about government inaction on drugs known to cause birth defects

Fry Electronics Team

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