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File photo of pharmacy shelves.
valproate

Timeframe still not decided for inquiry into epilepsy drug that can cause birth defects

The medicine was prescribed without warnings to patients for years after regulators knew about its risks.

A TIMEFRAME HAS still not been decided for a promised inquiry into the licensing of a drug to treat epilepsy that can cause harm to a foetus during pregnancy.

Nearly 17 months since the inquiry was announced, it has not begun and a timeframe has yet to be decided, the Department of Health has confirmed.

However, epilepsy charity Epilepsy Ireland says it is hopeful the inquiry, when it happens, will be able to give answers to families whose lives have been affected by the drug.

Valproate, a medicine used to treat epilepsy and bipolar disorder, can cause serious birth defects and developmental disorders to an infant if taken during pregnancy and women have been advised against using it unless no other treatment is possible.

The drug was prescribed in Ireland and elsewhere for years after the danger was discovered and many countries are now investigating its use.

In November 2020, Minister for Health Stephen Donnelly promised to hold an inquiry into the historical licensing and use of valproate in Ireland, where it is sold under the trade name Epilim. The inquiry is yet to commence.

In a statement to The Journal, the Department of Health said that “department officials are currently engaging with patient groups and other stakeholders regarding the terms of reference for an inquiry into the historical licensing and use of sodium valproate”.

“The timeframe for the inquiry has yet to be decided,” it said.

In response to a parliamentary question in March, Donnelly said that the details of the proposed inquiry and the establishment of a related stakeholder group were being considered by officials.

The department did not comment on the nature of the details under consideration when asked by The Journal.

The drug’s risk to infants has been made public in recent years, but campaigners in the UK found documents in the National Archives that indicated health regulators were aware of the risk as far back as 1973 but chose not to warn patients, saying it “could give rise to fruitless anxiety”.

The British Committee on Safety of Medicines (the equivalent of what is now the country’s Medicines and Healthcare Products Regulatory Authority) decided that the risk would be mentioned on data sheets for practitioners but excluded from package inserts “so that there would be no danger of patients themselves seeing it”.

A 2019 HSE report identified 3,126 people who were potentially exposed to valproate in utero between 1975 and 2015, of whom several hundred would have experienced a major congenital malformation or neurodevelopmental delay.

Speaking to The Journal, CEO of Epilepsy Ireland Peter Murphy said the inquiry will be important to understand how the drug was licensed and to answer questions about why it took so long for proper regulatory action responding to the risk associated with it in pregnancy.

“[It’s important] to move away from… the guilt that was involved for a lot of women who have children affected by valproate.

“There’s a certain amount of blame that people can attach to themselves for what’s happened and I think it’s vital that the inquiry addresses all of these issues, help people to understand that it wasn’t something that was the fault of the people involved,” Murphy explained.

As an advocacy and support charity for people with epilepsy, Epilepsy Ireland has engaged with the Department of Health about the proposed inquiry.

“To be fair to the department, they’ve listened to the concerns that ourselves and the families have had with their draft terms of reference,” Murphy said.

“There’s been a certain amount of back and forward and a certain amount of discussion on some of the key objectives or the key powers of the inquiry when it’s established. They have listened to what we’ve had to say and they’ve taken a lot of what we’ve had to say on board, which has been very welcome.”

He believes the terms of reference for the inquiry are almost ready, which would then allow a chairperson to be appointed and its work to commence.

“I think it’ll be a transparent way of looking at the history that’s happened and learning why it’s happened and getting answers, and importantly providing the families with some kind of a better future.”

In the UK, a two-year inquiry published a review in 2020 that criticised failures by manufacturers, regulators, clinicians and policymakers to uphold patient safety and to take action on the risks the drug poses.

A Sunday Times investigation explored the outstanding deficiencies in rectifying those failures, such as patients still receiving valproate in generic boxes without an information leaflet.

“That was something that was a problem here in Ireland before 2018 – pharmacists used to regularly prescribe or dispense valproate in plastic bags, sometimes without the leaflet,” Murphy said.

“That’s all been cleared up in Ireland – maybe there’s been one or two isolated incidents of this, but in general, the HPRA have resolved that issue. Almost all valproate is now dispensed in the original box with the patient information leaflet. There’s also cards the pharmacists are supposed to give out to people.”

However, Murphy said he isn’t confident that there aren’t still children being born who are affected by valproate being prescribed to their parent during pregnancy.

“The situation has improved a lot, everyone is more aware of it, there’s a lot of risk management steps that have been taken, particularly since 2018. But frankly, there’s a lot more that needs to be done on it,” he said.

“If you’re a woman of childbearing potential [taking valproate], you’re supposed to be on a pregnancy prevention programme. There are a number of different steps, one of which is an annual review that has to be done by your specialist, like a neurologist or epilepsy specialist nurse,” Murphy explained.

However, he said the resources aren’t in place to conduct those reviews with every relevant patient.

“There’s about 1,500 at the moment, many of whom would only be managed by their GP. They may have had epilepsy for many years and it may not be particularly active epilepsy so they may just be under GP care.

“They weren’t going to a neurologist, they weren’t going to go to a hospital clinic. These are all patients that have to be brought back into the hospital system but the capacity just hasn’t been there to actually do it.”

In 2020, a survey by Epilepsy Ireland of 150 women with epilepsy who took valproate found 17% were unaware of the potential impacts that valproate could have on a child.

And more recently, a study by the Royal College of Surgeons Ireland said only 60% of GPs ensured their patients understood the risks of the drug and used effective contraception.

In joint comments this week, Epilepsy Ireland and the Organisation for Anticonvulsant Syndromes (OACS) Ireland outlined that “urgency is needed from the Department, not just in terms of establishing the inquiry, but also with two other key safety measures we have been highlighting”.

“Namely, the appointment of specialist nurses to enable greater compliance with the PPP and the establishment of a ‘stakeholder group’ to address how risks can be further reduced.”

Women and girls taking valproate are advised not to stop taking it without first consulting with their doctor.

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