AN IRISH WOMAN whose children have been left with disabilities as a result of the epilepsy drug sodium valproate is to give evidence to a European safety review in London today.
Following the public hearing, the European Medicines Agency will determine whether warnings about the drug’s risks to unborn babies are strong enough.
In 2014, the EMA put measures in place across Europe to strengthen the warnings and restrictions on the use of the drug in women and girls due to the risk of malformations and developmental problems in babies exposed to valproate in the womb.
The FACS (foetal anticonvulsant syndrome) Forum Ireland, an umbrella group of patients and disability organisations, estimates that sodium valproate has affected at least 400 children with birth defects and developmental issues since it was first licensed here in 1983.
Children exposed to the drug in the womb have a 30-40% chance of serious developmental disorders and/or physical disabilities in 10% of cases.
‘They will never have a normal life’
Karen Keely, from Ireland, has three adult sons who have been affected by exposure to the drug. She’s set to speak on behalf of a number of Irish families who have also been affected.
Speaking about the effects the drug has had on her and her sons Harry, Lee and Lorcan, Keely said:
“My family is living evidence of the risks and the devastating impact of this drug.
Two of my three boys require lifelong care and will never be able to have a normal life. They will never be able to get married or have children. They have been robbed of all the joys of life.
“None of us want future generations to be affected or ignored in the same way that we have. But if we continue on the same path, that is exactly what will happen.”
Today’s public hearing is in response to ongoing concerns regarding the effectiveness of the measures brought in back in 2014, and to consider whether further EU-wide action should be recommended to minimise the risks for women taking the drug.
Last week, data released by three UK epilepsy charities found that almost 70% of women taking the drug had not been given adequate information, while 20% said their healthcare professionals did not initiate a discussion about the risks.
Epilepsy Ireland conducted a number of surveys of women taking valproate and found that while doctor-patient communication is improving since 2014, just 54% of women surveyed since last December said they had discussions about the issues with their healthcare professionals.
One in five were still not aware of the new restrictions in place since 2014.
Calls for action in Ireland
Epilepsy Ireland’s CEO Peter Murphy will also be in attendance at today’s hearing on behalf of FACS Forum.
“A lot more needs to be done. Measures to reduce risk must be outcome-driven and measurable,” Murphy said.
“The use of valproate information resources should be mandatory and informed consent should be obtained when using the drug in women and girls.”
Murphy is calling for the establishment of a valproate register and a “properly resourced” public awareness campaign.
“Warnings must be displayed on the external packaging of the drug and importantly, medication should not be dispensed without original internal and external packaging,” he said.
In addition to seeking better risk reduction measures, the FACS Forum is calling on the government to identify the scale of the problem in Ireland, to assess the needs of the families affected and to put in place appropriate pathways for the diagnosis and treatment of the condition.
A toolkit has been produced by the HSE’s National Clinical Programmes for Epilepsy, Mental Health and Medicines Management, which aims to reinforce the safety message for healthcare professionals and patients.
In a statement on its website, the HSE says:
It is important that valproate therapies are not prescribed for girls or women of childbearing age unless other treatments are not effective or are not tolerated.
The appropriate information should be given to all women on valproate treatment and the checklist should be completed.Despite the rollout of the toolkit by the HSE, Keely said more needs to be done to help families who are suffering.
“The HSE has taken some measures to improve awareness of the risks and to improve communication between patients and health professionals, these have largely been tick-box exercises with little regard for delivering real change,” she said.
“The response has been unsatisfactory and there have been no efforts made to address the needs of families already affected.”
This is the first time the EMA’s safety committee – the Pharmacovigilance Risk Assessment Committee – has held a public hearing to review the safety of a medicine.